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Care Partners | What Should You Know About the Bispecific Antibody Treatment for Myeloma?

April 16, 2024/in Care Partner Programs, Care Partner Resources, Care Partner Resources Resources, Care Partner TK, Care Partner TK Bispecific, MM Newly Diagnosed, MM Resources ND, MM Resources WPS, MM Whole Patient Support, Multiple Myeloma /by Kara Rayburn

Care Partners | What Should You Know About the Bispecific Antibody Treatment for Myeloma? from Patient Empowerment Network on Vimeo.

What are care partners essential when a loved one is undergoing bispecific antibody therapy for myeloma? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute explains the bispecific antibody process, reviews potential patient side effects, and shares resources that can help support care partners.

Alexandra Distaso, MSN, FNP-BC is on the Multiple Myeloma Nursing Team at Dana-Farber Cancer Institute.

Download Resource Guide

See More from the Care Partner Toolkit

Related Resources:

What Is the Role of Bispecific Antibody Therapy in the Future of Myeloma Care?

What Myeloma Patients Need to Know About Bispecific Antibodies

Evolving Myeloma Treatment Options | Bispecific Antibody Therapy

Transcript:

Katherine:

Hello and welcome. I’m your host, Katherine Banwell.

Being a care partner can be a demanding role. From understanding a loved one’s diagnosis to participating in treatment decisions, navigating care with a loved one can be challenging. That’s why the Patient Empowerment Network created the Care Partner Toolkit series to provide care partners with advice and information so that they can feel empowered and confident during the process. In today’s program, we’re going to learn about bispecific antibodies, how this myeloma approach works, who it’s right for, and the important role that care partners play throughout the process.

Before we meet our guest, though, let’s review a few important details. The reminder email you received about this program contains a link to program materials. If you haven’t already, click that link to access the guide to help follow along during the webinar. At the end of this program, you’ll receive a link to a program survey. Please take a moment to provide feedback about your experience today in order to help you plan future webinars. And finally, before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you.

Well, let’s meet our guest, nurse practitioner Alexandra Distaso. Alexandra, welcome. Would you please introduce yourself?

Alexandra:

Hi, Katherine. Thank you for having me. Yes, my name is Alexandra Distaso. I am a nurse practitioner at Dana-Farber Cancer Institute in Boston. I’ve been a nurse practitioner for just about nine years, and I’ve been at Dana-Farber for eight of those years.

Katherine:

Well, thank you so much for joining us today. I’m looking forward to having a discussion with you. Alexandra, you work with myeloma patients and their care partners on a regular basis. What is your role on the healthcare team?

Alexandra:

Yeah, so as a nurse practitioner, I’m seeing patients every day in the clinic that I’m here. And we’re seeing patients for both their kind of monthly check-in visits prior to treatment, sick visits, symptom management visits. So, either that’s once a month for your routine visit, or a couple of times a month if you’re going through a transition of treatment or having some sort of side effects we need to work on a little bit more closely.

Katherine:

Well, as I mentioned today, we’re going to be focusing on bispecific antibody therapy. It’s a relatively new approach. What is it exactly?

Alexandra:

Yeah. So, bispecific antibodies are a really exciting new therapy in myeloma that we’ve had for within the last year.

So, we have three bispecific antibodies that are currently approved right now. And the way that they work is, the medication binds to the tumor site on your plasma cell, where the myeloma cell is, and it binds to a T cell, which is your immune system cell. And it kind of works to redirect the T cell, your immune system, to kill off the cancer cells in your body.

Katherine:

Okay. How has this treatment impacted the state of myeloma treatment and care?

Alexandra:

This has been a great option for patients who are now triple-class refractory and further into their myeloma journey. The development of these new drugs represents really kind of a new era in myeloma. We’re having a lot of patients who are now exposed to more therapies with using three or four drug therapies in the first-line setting. So, having an extra line of therapy now further down the road has been a great option for a lot of patients.

Katherine:

Well, who is this treatment approach approved for, and what are the eligibility requirements?

Alexandra:

So, one thing that’s great about bispecific antibodies is that there is not a lot of restriction on who we can use these therapies for. So, these are great for patients who are a little bit more frail or maybe aren’t up for something like a CAR T, or whose disease is a little further along, and they don’t have time to wait for something like CAR T, which requires collecting of cells and manufacturing. What’s great about these medications is that they’re off the shelf. They’re ready to go kinda when you need them. There are restrictions in terms of how many lines of therapy that you need to have had before you can currently get bispecifics.

So, right now, you need to have four prior lines of therapy, and that needs to include an immunomodulatory agent. So, something like a lenalidomide (Revlimid) or a pomalidomide (Pomalyst), a proteasome inhibitor like bortezomib (Velcade), and a monoclonal antibody like daratumumab (Darzalex) before you’re eligible for these.

Katherine:

Have there been any recent bispecific antibody research developments that patients should know about?

Alexandra:

So, there are at least three bispecific antibodies that are hopefully coming into approval in the next several months to year, cevostamab being one of them. It’s a very exciting time for myeloma with all of these medications being approved. Teclistamab (Tecvayli), elranatamab (Elrexfio), and talquetamab (Talvey) in the last year. There’s still a lot of research on bispecific antibodies, especially trying to bring them all outpatient instead of just having inpatient treatment, and in addition, looking at them with other medications, such as teclistamab with daratumumab.

Katherine:

Okay. Well, thank you for that, Alexandra. This gives us a good idea of what the therapy is, and how it works to treat myeloma. So, let’s dive into the process. How is this treatment administered, and what’s the frequency?

Alexandra:

So, currently, all of the bispecifics are given as subcutaneous injections.

And all of them do require a current hospitalization visit, somewhere between four and 10 days, depending on which medication you’re getting and what schedule you’ll be on. So, everyone is required to be in the hospital. Again, we’re trying to move that outpatient to minimize patients’ times in the hospital if we have to. And you get a lower dose with that first exposure to each of the medications, and then we build up the dose for the doses in the hospital into what will eventually be your outpatient weekly, or biweekly dosing.

Katherine:

Okay. Are there only certain medical centers that have this therapy? How widely available is it?

Alexandra:

So, right now, the step-up dosing, the inpatient hospitalization part of bispecifics is primarily only at academic medical centers. So, it is a little bit more restricted in that initial therapy. But what we are seeing is that a lot of the community practices are able to enroll and give these medications in the community.

So, some patients will come see us for a consult and the initial step up, but then they’re able to go back to their primary team after the first cycle so that they’re not commuting back and forth to Boston all the time.

Katherine:

That’s good to know. So, once the therapy has been given to a patient, what happens next?

Alexandra:

When you’re admitted for these initial step-up dosings, we closely monitor you for reactions in the hospital. That’s why we kind of are doing this in in-patient settings to monitor very closely for CRS and neurotoxicity, which we’ll talk about a little bit later. While you’re in the hospital, they’re checking your labs every day, they’re monitoring your vital signs, they’re doing silly questions like, “Do you know your name and the year,” to kind of monitor how you’re functioning. Once you have passed kind of the step-up dosing, either you’ll come back to me and your primary team at Dana-Farber, or we’ll communicate with your local team to set up your schedule for moving forward.

Katherine:

What are the short-term side effects associated with bispecific therapy?

Alexandra:

Yeah. So, the short-term side effects that we’re watching for are these reactions in the hospital called CRS, cytokine release syndrome, and neurotoxicity.

So, the CRS is an inflammatory response where cytokines are released and usually cause a fever. We monitor and make sure that the fever isn’t being caused by some sort of infectious process or there’s no other cause for the fever. And if not, then there are medications we can give to help reverse these side effects while you’re in the hospital.

So, the way that we treat that is, again, we’ll make sure that there’s no sort of infection or other reason for a fever. And if the patient continues to have the fevers and they have low blood pressure and changes in their oxygen needs, which is kinda what happens if this inflammation progresses, is we’ll give things like dexamethasone, a steroid, or another medication called tocilizumab to help kind of reverse the effects of the cytokine release.

Katherine:

Who else is on the healthcare team when someone receives these therapies?

Alexandra:

Yep. So, you’ll always meet with your oncologist or an oncologist at the academic medical center where you’re going to be getting the medication to go over potential side effects, what the treatment entails, and consent. We have nurses here that are specific to bispecific antibodies, that help coordinate with your local team if you’re going back to your local practice. We have the infusion nursing team who are the ones who are actually giving the bispecific antibody therapies. They explain kind of what to watch for at the site where the injection goes. And then we have pharmacists who are also available to meet with you and go over any questions you may have about the treatment.

Katherine:

What do we know about long-term side effects? Are there any?

Alexandra:

So, long term, what we’re really seeing is risk for infections. So, all of these medications lower your blood cell counts, and we have to watch for these opportunistic infections, fungal, bacterial, viral.

Which is why it’s important that we have everyone on supportive medications to try and prevent that from happening. But long term, that is certainly something that we’re seeing. With the talquetamab, there can also be some skin and taste changes, and those are not necessarily right at the inpatient dosing, but we can see that. But those are things we’re also managing in the months after the initial therapy.

Katherine:

Okay. Why is it so important that care partners let the healthcare team know of any changes that they see in their loved ones?

Alexandra:

I say this to my patients and their families all the time. They know their family member best, and they may be one to notice that they’ve been more tired, or their energy just isn’t the same, or they do have a little cough that maybe the patient hasn’t even really noticed. And those are all things that we want your observation, we want you to speak up about, because the sooner we address some of these problems, the less complications the patients may have.

Katherine:

What are the supportive medications for somebody who might be having side effects?

Alexandra:

Yeah, so with the talquetamab, which we’re primarily seeing a lot of skin side effects and mouth discomfort, a lot of the time we have special mouthwashes to prevent discomfort and irritation. Things like biotin to just keep the mouth moisturized. Steroid creams and nail ointments to help with sometimes some peeling of the skin. And then for all bispecifics, we have everyone on viral prophylaxis. Something like acyclovir (Sitavig or Zovarax) or valacyclovir (Valtrex). PJP prophylaxis. So, something like sulfamethoxazole and trimethoprim (Bactrim) or dapsone (Aczone). And almost all of our patients are on an IVIG infusion once a month to help support their immune system and prevent against infections.

Katherine:

Alexandra, you mentioned care partner looking for a cough, for instance, in a patient. What other things should care partners be looking for?

Alexandra:

Any kind of change in the patient’s baseline is always helpful to know. So, if people are feeling much more tired, even if you’re not due for your therapy, sometimes calling to say that they just don’t seem themselves, we can check their blood counts. And again, sometimes they might need a blood transfusion, or their white count might be quite low, and they might need some Neupogen or filgrastim to help kind of support their blood counts. So, really kind of notifying us, even if it doesn’t seem like a big thing, it’s always better to call.

Katherine:

Yeah. How long will a patient be on a therapy like this?

Alexandra:

So, we still don’t know exactly the long-term duration of response. I think the most recent update we have was a median of 18 to 22 months was the last report. Which is a great response for what we have in myeloma.

Katherine:

So, does the length of time a patient is on a therapy depend on the patient themselves, their comorbidities, et cetera?

Alexandra:

Sometimes they’re comorbidities, but it is usually more just how their myeloma responds. So, every month when you’re coming in for therapy, even if your therapy is weekly or biweekly, every month, we’re monitoring your myeloma markers, and every month we’ll go over those markers to make sure we’re still seeing a good response. Usually, we’ll do a PET scan or a skeletal survey to also monitor everyone’s bones and any other lesions, they may have.

Katherine:

What is considered an ideal response?

Alexandra:

An ideal response. A lot of times we’re seeing everyone’s light chains go to even an undetectable level. So, even if we see some partial responses where the light chains were, let’s say they were 100 and they’re going down into the normal range, that’s still wonderful.

If it stayed like that for months, we wouldn’t make any changes. But best-case scenario, we see them go to a level that we can’t detect them in the blood work.

Katherine:

As I mentioned, Alexandra, this program is aimed at helping care partners understand the process and how they can support their loved ones. What do you feel is the care partner’s role?

Alexandra:

I feel like the best way for care partners to support patients is to kind of take the time to learn about the myeloma and the therapy and try to do the best they can to just be there for not just moral and emotional support, but the other little things that they may need. Coordinating rides, if it’s a family member, asking friends for help.

And then other things like insurance phone calls can be incredibly time-consuming and taxing. Or waiting at the pharmacy to pick up medications. Any, even little things like that, I think take a huge load off the patients who are doing this day in and day out.

Katherine:

Yeah. Are there key questions that care partners should ask as they begin the process?

Alexandra:

I think the best thing that patients and caregivers can do is if they have questions prior to the visit is to make a list. ‘Cause, I’m guilty of this myself, as soon as I show up at my doctor’s office, I completely forget what I wanted to say. So, making a list prior to the appointment, I think, is hugely beneficial. And then I don’t think that it’s ever a bad thing to ask for the doctor or nurse practitioner or pharmacist, whoever you’re meeting with, to see if they can repeat themselves. We’re putting a lot of information into a very short period of time.

And to try and keep track of, again, schedule, supportive care medication, when you’re going to need to be in the hospital, how long, what your follow up will be, taking notes during the visit or asking to hear it again is always helpful. Not even just for the caregiver, but sometimes for the patient who’s still trying to wrap their head around some of the change in therapy.

Katherine:

Right. Yeah. That’s really good advice. As we’ve covered, it’s not always easy being a care partner. What would be your best advice for those who are caring for someone undergoing bispecific antibody treatment?

Alexandra:

I would say it’s hard to put out how important care members are to the entire care team. Again, not just for the logistical, getting the patients to appointments, getting their medication, but really having someone the patient feels comfortable to be able to lean on. And again, they may say, “I’m so overwhelmed in these visits, and I really need some help.

Could you ask these things?” Helping them keep track of all these medication changes and appointments and visits and any sort of even small things like grabbing them a water so that they’re staying hydrated. Those little things make such a difference to people. And I think doing those things, no matter how small they feel, really helps support the patients through these changes in therapy.

Katherine:

Besides yourself, what other staff members can care partners turn to for support?

Alexandra:

So, at our office, we have an amazing group of triage nurses who are available Monday to Friday all during office hours. We have after-hours. If your patient or family member spikes a fever and you’re worried they just don’t look good, there’s always a doctor on 24/7 that you can page to kinda ask for advice and see what to do from there. And again, we have infusion nurses who are giving these injections every day.

And they are wonderful resources on what you might feel later in the day, what that site might look like, side effects that might pop up. So, really, anyone wants to be there to answer questions to make it easier for the patient or the family.

Katherine:

Are there social workers or psychologists on the team as well?

Alexandra:

Yes. We have an amazing group of social workers at Dana-Farber. And one thing that I really like about the way our program is run is that we have a social worker who is dedicated specifically to myeloma. So, they’re very familiar with these medications and the hospitalization requirements, which can be extremely tough. And so having resources and just someone to talk to, both through social work and our psychosocial oncology department, is also a wonderful resource to have.

Katherine:

What about online resources? Do you have any recommendations?

Alexandra:

So, I think that the IMF, the International Myeloma Foundation, and the NCI, have amazing resources for patients.

Actually, the IMF has an entire caregiver support page with kind of caregiver self-help, and ways that you can care for the patient. Care for the caregiver, and care for the patient. I think the MMRF has wonderful resources, and they also have a lot of online forum videos about bispecific antibodies and the different treatments for myeloma that are available if you want to learn more. And then same thing with The Leukemia & Lymphoma Society. Excellent resources online.

Katherine:

Thank you so much for all of that. What about self-care for the care partner? Why is that so important?

Alexandra:

I feel like this is such a hard thing for people because it always gets put on the back burner. And I know a lot of the times it’s like when you’re on an airplane and they say, “Put your oxygen mask on yourself before you put it on anyone around you,” because you can’t help others if you’re running on empty. You really need to take care of yourself.

Make sure you’re not just functioning, that you’re eating and sleeping and hydrating and taking care of all your own personal needs, but also that you’re taking time for you to kind of reflect and have some time to decompress from everything you are trying to do to help your family member or loved one.

Katherine:

Why should care partners speak up and ask questions about how they’re taking care of the patient, what they can do to help the patient and themselves?

Alexandra:

Yeah, I think that these bispecific antibodies are new, and one great thing about them is that overall they are really well-tolerated in general. So, hopefully, it means the patient is feeling pretty good and having a really nice response to their therapy. But if they’re not feeling good, we want you to speak up at home. Again, sometimes patients are the last person that want to tell you there’s a problem ‘cause they’re worried about missing their therapy.

And I always tell patients it’s sometimes not safe, if you do have a cough, if you had had a fever, we want to be safe and maybe hold a dose of therapy to address maybe something else that’s going on and avoid further complications another week. So, if you’re noticing something, I always encourage people to speak up and let us know of any concerns they’re seeing at home.

Katherine:

Alexandra, we received some questions from audience members prior to the program. Amelia wants to know, are bispecific antibodies covered by Medicare?

Alexandra:

I believe they are. I would have to double-check, but I’m fairly certain some of our patients have Medicare and have had bispecific antibodies.

Katherine:

Okay, so for the patient who is getting the bispecific antibody treatment, what are the lifestyle alterations that we as care partners need to make? Any changes to their diet?

Alexandra:

No. I mean, a lot of patients definitely want to maximize anything they can do to make themselves feel better and help their myeloma respond. But what we’ve seen is that there’s not one particular diet or cutting out one particular food that’s going to make a long-term or significant impact on any cancer therapy. The best thing that you can do in terms of diet or lifestyle is to try and just maintain a healthy lifestyle to balance all your other medical needs. You want to make sure your blood pressure is in good control.

You want to make sure if you have diabetes, that your blood glucose is in a good range. Because having those things be in good control is going to make your therapy and potential complications more manageable.

Katherine:

Okay. Can bispecific antibodies cause anemia?

Alexandra:

Yes. So, bispecific antibodies, all of the three that are approved, can cause lower blood counts in all of your blood counts. Red cells, white cells, and platelets.

I will say we’ve usually seen that happen more at the beginning of therapy, and then as patients are on the therapy longer, their counts do tend to recover. So, whether that is from just the initial disease response, or it might be from the cytokine release syndrome, we see low blood counts with that, we don’t always 100 percent know. But it certainly can lower all of your blood counts.

Katherine:

Okay. Gina asks, is there any home equipment we will need to help during treatment?

Alexandra:

Nothing is required. So, you’re not required to have any sort of medical devices at home. Well, I’ll take it back. I would like everyone to have a thermometer so that if you do feel sick, you can at least check your temperature. Sometimes having a blood pressure cuff or an oxygen monitor at home, that can be helpful if you’re not feeling well, just to see if things are out of range. But there’s definitely not a requirement for those things at home.

Katherine:

Okay. What can care partners do to help the patient have a more positive outlook during therapy, especially when they’re feeling down and depressed?

Alexandra:

Sometimes I think the best thing that you can do is acknowledge that this is really hard. I mean, changing therapy, having myeloma, going through a hospital stay is really challenging. And sometimes patients just need to hear, “This is a really hard situation, and you’re doing a great job. Taking all your medication, going to the hospital for these treatments, coming to your follow-ups.” Even those small things, giving encouragement and acknowledging how hard that is, even if it seems like it’s not a big thing, can really give a patient a different perspective on how things are going.

Katherine:

Are there support groups specifically for care partners?

Alexandra:

We do have a care group, a support group here at Dana-Farber that is for care partners, run by our social work team. I think it is both now virtual and live, but I’m not positive if they’ve gone back to in-person support groups yet. But I do think the American Cancer Society has some good online groups as well.

Katherine:

Okay, that’s good to know. Thank you. So, before we end the program, Alexandra, I’d like to get your thoughts about the topic. What message do you want to leave the audience with?

Alexandra:

I would tell them that bispecific antibody therapies are a great option for patients in the current myeloma setting. I know that being in the hospital for a week is an incredibly big ask, especially after everything patients are going through with their treatments and then having their disease progress. But the inpatient stay for the long term, hopefully, outpatient benefit of a quick injection every other week with minimal toxicity is certainly worth it. And so I would try to keep an open mind about bispecifics and get excited about them.

Katherine:

Thank you so much for joining us today, Alexandra. We really appreciate it.

Alexandra:

Thank you so much for having me.

Katherine:

And thank you to all of our partners. If you would like to watch this webinar again, there will be a replay available soon. You’ll receive an email when it’s ready. And don’t forget to take the survey immediately following the webinar.

It will help us as we plan programs in the future. To access tools to help you become a proactive care partner, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for being with us.

Elevate | What Role Can YOU Play in Your Myeloma Treatment and Care?

April 9, 2024/in Elevate Myeloma, Elevate Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

Elevate | What Role Can YOU Play in Your Myeloma Treatment and Care? from Patient Empowerment Network on Vimeo.

How can you elevate your overall myeloma care and treatment? Myeloma expert Dr. Sikander Ailawadhi discusses advances in myeloma care, the importance of patient participation in myeloma treatment decisions, and shares key advice and resources for self-advocacy.

Dr. Sikander Ailawadhi is a hematologist and oncologist specializing in myeloma at Mayo Clinic in Jacksonville, Florida. Learn more about Dr. Ailawadhi.

Download Resource Guide

See More from Elevate Myeloma

Related Resources:

Self-Advocacy in Myeloma Care | Advice From an Expert

Myeloma Combination Therapy | What Patients Should Know

What Should You Know About Emerging Myeloma Treatment Options?

Transcript:

Katherine:

Hello and welcome. I’m your host, Katherine Banwell. It’s no secret that the quality of care that patients receive can vary depending on a number of factors and patients who are educated about their condition and involved in their care may have improved outcomes. That’s why the Patient Empowerment Network developed the Elevate Series, which aims to help patients and care partners be informed about their disease and more confident participating in conversations with their healthcare team.

In today’s program, we’re going to hear from an expert to learn more about myeloma and hear tips and advice for accessing better overall care. Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. Well, let’s meet our guest today. Joining us is Dr. Sikandar Ailawadhi. Dr. Ailawadhi, welcome. Would you please introduce yourself?

Dr. Ailawadhi:

Yes. Thanks a lot, Katherine. Thanks for this opportunity. To all our viewers, listeners, I’m Sikandar Ailawadhi. I’m one of the hematologists oncologists at Mayo Clinic in Jacksonville, Florida. So, at this Jacksonville, Florida site of Mayo, I lead our myeloma group, and we have a very comprehensive program with inpatient outpatient treatment and lots of clinical trials, cell therapy, et cetera. I look forward to the discussion.

Katherine:

Well, thank you so much for joining us today. I know you’re a busy man. I’d like to start by discussing your role as a researcher. You’re on the front lines of advancements in the myeloma field. So, what led you here, and why is it so important to you?

Dr. Ailawadhi:

Yeah. So, Katherine, thanks for asking that question because before jumping into the disease state and clinical trials and data, et cetera, I think it’s important for all of us to keep in mind what kind of brought us here or what kind of keeps driving us further. So, I think for me, the decision to come to the field of multiple myeloma was very strongly influenced by my mentors.

My mentor who shaped my career and also got me interested in this area. I think during my training, it was the time that newer drugs were just beginning to come about. So, the field of myeloma was just beginning to change. And since then, obviously, there have been lots of advancements, lots of research, clinical trials, new drugs, so that the outlook for not only the myeloma patients has improved quite a bit.

But also, for physicians, researchers, us academicians who work in this field, the opportunities are much, much more. And because I trained at a large academic center, I – and again, with working with my mentor, I got so interested in the clinical research because frankly giving the available drugs is one thing but being at that cutting edge where you can bring newer drugs to life, newer drugs to our patients’ lives, that was what was most important for me and is the driving force for my work today.

Katherine:

Thank you for that explanation, Dr. Ailawadhi. I appreciate it. So, when it comes to choosing therapy for myeloma, it’s important to work with your healthcare team to identify what might be best for you. How would you define shared decision-making and why is this so critical to properly managing life with myeloma?

Dr. Ailawadhi:

Excellent question, Katherine. Shared decision-making or a process in which the physician, the health care team, and the patient, their caregivers, everybody comes together, shared, to make a decision that we feel is in the best interest for that patient at that time. That is the whole concept.

Whenever we think about treatment decisions, in our mind, the three main components that have to be considered every single time. Not just newly diagnosed or relapsed or third line or whatever, every single time a treatment decision has been taken, we must consider patient-related factors. What is their preference? What are their goals? Do they have caregiver support? How far do they live? Do they want IV? Pills? Any side effects that are there?

Comorbidities? Other issues? Financial conditions? Everything comes into play, patient-related factors. Then, there are disease-related factors. How fast is the disease growing? Is this new? Is this old disease, high-risk, low-risk, or standard risk? Or what has been given before, et cetera. So, patient and disease-related. And the number three is the treatment-related factors. What is being considered for the patient? What are the ins and outs, pros, and cons?

All of this has to be laid out in front of the patient and preferably also their caregiver if the patient has someone who they can share their decision with.

And when we put all of that in the mix, we come up with a decision which is hopefully in the patient’s best interest. They are more likely to go through with it. They are informed. They are involved in their care. And then, hopefully, if the patient starts on a treatment that they are interested in, knowledgeable about, and committed to, we’ll be able to keep the patient on that longer term and get the best benefit out of it.

So, in my mind, the main reason for shared decision-making is to make sure my patient is committed to that treatment. They understand that treatment. And we make this kind of bond between us as clinicians and our teams and the patient and their home team, their family team, their caregiver team so that everybody is working together with a singular goal. Right treatment for the right patient at the right time because it must be patient-centric, not research or clinician, or drug-centric.

Katherine:

Yeah. Okay. That’s good advice. What are myeloma treatment goals, and how are they determined?

Dr. Ailawadhi:

So, I think the myeloma treatment goals can be very different depending on what vantage points you’re looking from. My treatment goal is to provide the best treatment for my patient that has least side effects, gets a deep control, and my patient’s able to live long with a good quality of life. Okay. But that’s my goal. I need to figure out what my patient’s goals are, and sometimes our patient’s goals are very different. A patient’s goal might be that they want to really avoid side effects. Well, they want to live, lead their quality of life, and keep traveling. And this happens on a day-to-day basis.

Just the other day, one of the patients said, “Well, I really want to keep driving around in my RV with my wife, because that is what we had wanted to do at this point of our life. What can you do to help me control my disease, but keep me driving my RV?” And we literally had to figure out where all they were traveling. We identified clinics close to them and connected with physicians so that they could continue their treatment wherever they were. So, the patient’s goals are very important, and in fact, I would say they are paramount. So, understanding what the patient wants. They may be wanting to control pain. They may be wanting to just live longer.

They may be wanting to delay treatment so that they could watch their daughter’s soccer game. I’m just saying that the goals can be very different. It is important to lay them out. Every time you’re making a treatment decision, the goals should be laid out into short-, mid-, and long-term goals. I should bring my goals to the discussion. The patient should bring their goals to the discussion, and we come up with whatever is the best answer for them that suits them.

Katherine:

So, you’re trying to maintain an open dialogue, an open line of communication, yeah.

Dr. Ailawadhi:

Absolutely.

Katherine:

What sort of tests should be done following a myeloma diagnosis?

Dr. Ailawadhi:

Generally, when myeloma is suspected, we need to know what the basic blood counts are, something that is called a CBC, complete blood count. We’re looking for anemia, low white blood cells, low clotting cells, or platelets. We want to do serum chemistries or blood chemistries, looking for kidney function, liver function, electrolytes, calcium, et cetera.

Then, we want to do some kind of an imaging of the body. Generally, routine X-rays are no longer done, and the most preferred is a PET-CT scan, a PET scan. We do PET-MRIs frequently. So, there are different tests available, but you want a good test to know what’s the state of bones and presence of any lesions or tumors. And then, the important question comes is doing a bone marrow biopsy.

The reason for doing a bone marrow biopsy, and even if somebody has had a biopsy done from a compression fracture, et cetera, that diagnosed myeloma, a bone marrow biopsy still should be done. It gives us a lot of pieces of information.

It tells us what is the percentage of plasma cells in the bone marrow. So, what is the disease burden we are starting with? Secondly, that bone marrow biopsy specimen can be sent for what is called a FISH testing, which is fluorescent in situ hybridization.

It is basically looking for any mutations in the cancer cells. Based on those mutations, myeloma can be classified into standard or high-risk myeloma. And sometimes our treatment choices are differed based on whether somebody is standard or high-risk. So, blood work, basic counts – and I skipped over one of the things. Right after chemistries, I wanted to add also are myeloma markers.

There are typically three lab tests of myeloma markers. One is called protein electrophoresis. It can be run in blood and urine. Ideally, it should be run in both. One is immunoglobulin levels, which gives us the level of IgG, IgA, IgM, et cetera. And the third one is serum-free light chains, which is kappa and lambda light chains. Neither one – none of these tests eliminates the needs for the other.

So, everybody, in the beginning, should have complete blood count, blood chemistries, SPEP or serum protein electrophoresis, urine electrophoresis, immunoglobulins, light chains, imaging, and then a bone marrow. This completes the workup. Then, based on that, the treatment can be determined.

Katherine:

Well, you mentioned lab work. How often should tests and blood work be done?

Dr. Ailawadhi:

Good question. Very, very important question because we see very frequently that the patients come in, they’re getting treatment somewhere, and every single time the patient steps foot in the door of that institution or wherever they’re going, they got a blood draw. That’s how they start their day. It’s needed more frequently in the beginning but needed less frequently later on.

Generally, the myeloma markers, those protein electrophoresis, immunoglobulins, light chains, they are frequently done just about every month. Generally, in myeloma, one month, three to four weeks is one cycle. So, at the beginning of every cycle, you want to know how good your response was. So, the myeloma markers once a month.

The blood counts and chemistries in the first month, first one to two months, they can be done every other week or so just to make sure counts are fine, no need for transfusions, kidney/liver is okay, et cetera. But after the first couple of months, when the body is used to the drugs when the patient is settled with the treatment, frankly, once-a-month labs are good enough. We don’t really need labs on every single treatment visit. Because the other thing that happens is some of these drugs can lower the blood counts normally during treatment, but they have a rest period at the end of the cycle when the counts recover.

So, if somebody does labs in the middle of the cycle when the counts are expected to be down but not an issue, treatments are stopped, and growth factors are given. And this is done, but that is not really necessary. So, first couple of one to two cycles, maybe every other week to make sure counts are okay. Myeloma markers monthly, but after the first couple of months when things are settled, once a month should be sufficient.

Katherine:

Okay. What questions should patients be asking about their test results?

Dr. Ailawadhi:

Yeah. Very, very, very important. In fact, whenever I’m speaking in a patient caregiver symposium or anything, I spend a lot of time on these test results because frankly, a lot of times it sounds like jargon and the people talk about, “Oh, my ratio is going up,” or the doctor is saying, “Hey, your immunoglobulins are normal. You’re in remission.” But so, I think the patients need to understand and ask from their doctors, “What is my marker of the disease that you will be following?” And I’ll tell you that immunoglobulins, that IgG or IgA level, is nearly never the marker. It’s either M spike or light chains, generally one of those.

So, the patients need to understand what is their marker. They also need to know what did their bone marrow show. What was the percentage and what was the FISH result or cytogenetic result? I think other than the tests, I will also add the patients need to ask their doctor a lot of these questions that you’re asking me. How frequently are the labs going to be done? Why is it important? Why was a certain treatment selected? What is the expected outcome? What are the chances that I can go into remission? How long does the intense treatment stay?

When does it go to some kind of a maintenance? Et cetera, et cetera. Basically, you want to understand everything about the disease and its treatment. It is overwhelming. This is a lot of information. A lot of times the patients may say, “Well, I got a diagnosis. I got a treatment started. I just need to move on.” That’s right. But once you spend all that time initially understanding your diagnosis and the treatment and the disease, it’ll make the rest of the journey much, much easier.

Katherine:

That’s really helpful as we drill down a little further. What are the types of treatments available for people with myeloma?

Dr. Ailawadhi:

So, myeloma has a lot of treatments available. We can classify these treatments into different classes of drugs, or we can classify the treatment as early lines or late lines of therapy. Or we can classify these treatments into cellular therapy or targeted therapy or chemotherapy. There are ways of classifying it. What I would suggest is we should think about classes of drugs. We have something called proteasome inhibitors. That class has three drugs FDA-approved. We have something called immunomodulatory drugs. That class has three drugs also approved, but generally, we use two.

Then, there are something called monoclonal antibodies. There are three drugs approved there as well.

There are cellular therapies or CAR T-cell therapy. There are two of them approved. There is also a stem cell transplant that is used as a part of treatment sometimes but is different from CAR T. Then, there are other immunotherapy, something called T-cell engagers, in which also there are three drugs approved. In fact, as I’m saying to you, I’m trying to think…yeah, wow. Every class has three drugs. That’s so weird. And then, there are some other classes of drugs. There is something called exporting inhibitors. There is a drug there. All said and done, there are these different classes of drugs.

There are some guiding principles for myeloma treatment. Generally, three to four drug combinations or regimens are better than two drugs. So, a patient should be in the initial therapy or later lines. Also, preferably be getting a three-drug combo. And I forgot to mention steroids, which are an important part of every regimen in myeloma, almost every regimen. So, three drugs or four drugs are better than two. That’s important to keep in mind. Longer durations of treatment are generally considered better. We should not tinker with the regimen’s recipe too soon. As long as the patient is tolerating for a longer duration before making any major changes like maintenance.

Generally, maintenance in myeloma is not a response-assessed thing like, “Oh, you’ve responded in two months. We should go to maintenance.” Generally, in myeloma, maintenance transition is a time-dependent thing. Okay, you’ve had six or nine months or 12 months. We can go to maintenance, sort of a thing. So, even if somebody has responded, they may need the same treatment for a longer period of time to keep the disease quiet.

And so, I think these are the different categories of drugs. We pick and choose from different categories to combine and make a regimen. The CAR T-cell therapy, the two CAR Ts that are approved, or the three T-cell engagers that are approved, they are all currently used as single agents. They are not combined with anything, not even with steroids.

Katherine:

Yeah, I see. How do clinical trials fit into a treatment plan?

Dr. Ailawadhi:

Okay, that’s an extremely important question, and you’re asking it from a person in my clinic about two-thirds of the patients who are on treatment at any given time are on clinical trials. So, I am very heavily, I shouldn’t say biased, but a proponent of clinical trials. In my opinion, clinical trials are a part and parcel of treatment for every single patient. In fact, when you look at the NCCN guidelines, which are National Comprehensive Cancer Network, which is large institutions across the country, and they make guidelines for all cancers, it is mentioned in every single setting that clinical trials should always be considered.

So, I personally feel that whenever the patient is coming up with a treatment decision, we talked about shared decision-making in the beginning, it’s important for them to ask at every single juncture, “Do you have any clinical trials available for me?

And if you don’t have any clinical trials available, are there any clinical trials that I should consider, even if it means going to a different place and getting an opinion?” I know logistically it’s challenging, but we should at least know our options. So, in my opinion, clinical trials should be considered at every single juncture, because that is how patients get access to either a new drug, a new treatment, or a different way of using the current drugs, which might actually improve upon their current state. So, everybody all the time should consider clinical trials.

Katherine:

That’s great information, Dr. Ailawadhi. Thank you for that. I’d like to add that if you’re interested in learning more about emerging treatments, such as CAR T-cell therapy, PEN has a number of resources available for you, and you can find these at powerfulpatients.org/myeloma, or by scanning the QR code on your screen.

So, the symptoms of myeloma, as well as the side effects of certain medications, can vary greatly among those being treated. How do you approach symptom management with your patients?

Dr. Ailawadhi:

It is extremely important that we focus on the symptoms, whether it’s coming from the disease or it’s coming from the treatment. Because frankly, if a person is responding to the treatment, you want them to stay on the treatment for a longer duration of time, so the disease can stay controlled.

If we don’t handle the symptoms from the treatment or the side effects that are happening or if the disease is causing too many symptoms, it is more likely that either we’ll start cutting down the drug too much or stopping the treatment, et cetera, and then the disease just comes back. In some cases, that is necessary, but generally we would like to modulate the treatment or address the symptoms.

So, one important piece that we should do, or at least we try to do over here, is that every single time that we talk to the patient for any of the visits – while there is enough time spent on, “Well, these are your labs, your diseases responding markers, SPEP, and M spike, and light chain,” and all that stuff – we spend a lot of time asking about symptoms.

It is, I understand, challenging to cover everything, but to familiarize what drugs cause what kind of symptoms, and at least making sure that we ask those from the patient. For example, IMiDs like lenalidomide (Revlimid) can cause some diarrhea, can cause fatigue, can cause sleepiness. Well, I must ask about diarrhea from all my lenalidomide patients.

Bortezomib (Velcade) can cause neuropathy. It can give rise to shingles. I must ask my patients for every bortezomib-treated patient. “Hey, do you have any neuropathy numbness, or tingling?

Are you taking your medication to prevent shingles, et cetera?” I’m just saying we may not be able to do a comprehensive review of every single symptom from every single patient, but whatever the target side effects are important to know every single time. We educate the patients about these side effects so that they are aware of them, and they can report these side effects. And then, if the side effects are happening, any symptoms are happening, then is it to the point that we need to stop the treatment?

Frequently, we do take drug holidays for a few weeks just to make sure, okay, we know is it coming from the drug or the disease? And every now and then, we realize, well, the drug was not even causing the symptom, because we stopped it, and the symptom stayed. Or so then, why stop the drug? There’s no point stopping it if I can’t control the symptom. So, understanding whether it’s coming from disease or drug or something else, addressing them, making the changes appropriately to lower the dose, space them out, et cetera. All of that is done. And of course, like I said, importantly, educating the patient is so very important. I’ll add one quick thing. We focus on the drug-related effects.

As you rightly mentioned, Katherine, the disease itself can cause a lot of symptoms. So, generally, when I see a new myeloma patient, in the first couple of visits, we’ve done all the testing, we’ve discussed the treatment, and we’ve addressed some of the basic symptoms like pain, for example. That is big in myeloma.

But then, when the patient has started treatment, generally within the first two months, the focus that our clinic has is we need to control any side effects, and we need to address any symptoms that are being left over from the disease. And that’s when we start referring patients to interventional radiology for any bone procedures or palliative care for pain control or neurology for neuropathy, whatever so that we are controlling all the symptoms.

And that’s when we hopefully get the patient as close to their baseline as possible.

Katherine:

I would like to talk more about self-advocacy, Dr. Ailawadhi, managing the worry associated with a diagnosis, concerns about relapse, side effects. It can lead to emotional symptoms like anxiety and fear for many. So, why is it important for patients to share any worries they’re having with their healthcare team?

Dr. Ailawadhi:

Yes. Extremely important. See, nobody’s thinking, “Okay, I’m going to have cancer today.” Nobody’s prepared for it ever. Cancer is always a diagnosis that comes out of the blue, blindsides us, and then suddenly we have to change the rest of our life because of it. Not only our life, our caregiver’s life, family’s life, everything changes.

So, it is okay to admit that it is difficult. It is okay to admit that we need help. And, Katherine, I like your kind of the use of the word, self-advocacy, although I want to qualify it.

A lot of times we say patients got to be their own advocates. But if a patient doesn’t know what to ask, they’re going to be lost. My thought is it is okay to – the first and foremost that a patient or their caregiver can do is please report your symptoms or how you’re feeling. And those symptoms could be physical, those could be psychological.

Please report what are you feeling, what are the symptoms. On a drug, what are the side effects, et cetera, so that your healthcare team can try to address them. Don’t ever assume, “I am on chemotherapy. I should have diarrhea.” No. Don’t think, “I’m on chemotherapy. Other patients outside in the waiting room look sicker than I. I feel embarrassed to ask a question.”

We hear this so many times. A lot of patients will say, “I feel embarrassed to ask that I’m going through this symptom, because I see sicker people outside.” Yeah, but know when I’m with you as a patient, you are it. I’m not thinking about anybody else. And I don’t want anybody else’s decision to obscure or cloud our relationship at that visit. Please report your symptoms. Please ask for help. To me, that is good enough self-advocacy. Self-advocacy is not saying, “I should get this treatment, not that treatment.” But self-advocacy could mean, are there clinical trial options? I know I live far away from a large center. Could I get a tele-visit with a large center? Could I get a second opinion from someone? Those are all very, very reasonable questions, and by asking those questions, a patient is advocating for themselves.

Katherine:

As you alluded, there’s a whole healthcare team working with each patient, and there’ll be people on that team who can help support a patient’s emotional needs. So, one thing that’s on the mind of many viewers is the financial aspect of care. And you mentioned that earlier everyone’s situation is different, of course, but where can patients turn if they need resources for financial support

Dr. Ailawadhi:

Very important question. I can tell you every day when I come into my office, my nurse has a stack of documents ready for my signature. Every single day. Today, there was only one, but there could be different numbers. And these are generally from foundations from diagnosis confirmations, et cetera. Things that we are filling on and signing on behalf of our patients so that they are able to receive resources, whether it’s from a pharmaceutical manufacturer, a foundation, or society that has funding available, et cetera. I should start by saying, Katherine – and I feel embarrassed to admit this, but I should start by saying, I may not have all the answers for my patient during that visit.

But I think the very important piece where we can start is asking the patient, “Is this causing any financial strain on you?” As I mentioned earlier, we don’t think about, “Oh, I’m going to have cancer today. Let me prepare for that.” Or “I’m going to have cancer five years down the road. Let me prepare for that.” We’re not always ready for this. It’s okay. It’s important for me to ask if there is a problem, and it’s important for the patient to admit there’s a problem or say, “Well, I’m having difficulty with copayments.” And whatever may be difficult for one may be okay for the other. So, I shouldn’t assume. So, that discussion must happen.

Generally, in our setup, what happens is if the patient brings up a concern, if I identify a concern, or if we think something may be going on, but we’re not very sure about it, we tend to bring in our social workers. The social workers are typically the ones who are able to do that discussion with the patient, talk about what are the resources available. What are the foundations that we can apply to? We have patient navigators who can do the similar things. So, the patient navigator, social worker, there are different individuals who will be able to provide much more granular information. I also strongly suggest patients to join support groups.

There are lots of resources, which I may not be aware of during our visit with a patient, but I can connect to the social worker, their patient navigators, and online support.

Katherine:

Thank you for that. It’s great advice. As we close the program, what would you like to leave the audience with? Why are you hopeful?

Dr. Ailawadhi:

First of all, I should admit, yes, I’m very, very hopeful for myeloma. I started my work with myeloma or my time working in this field in somewhere around the year 2000 or around that year. In the early 2000s, the average survival of a myeloma patient despite treatment was about two to three years.

Today, while national data is suggesting somewhere in the vicinity of 10ish years, give or take, all of us who are myeloma-focused physicians and have specialized centers that we work in, we have many patients who are living in excess of 10 years and pushing the envelope. In fact, my longest survivor is now maybe 34, 35 years with myeloma, and she’s not even been on treatment for a few years.

This is what gives me hope. That it’s not only that patients are living longer, more and more patients are living with less disease burden, better quality of life, and in a lot of cases, not even on a treatment. Our myeloma world is now going from everybody should be treated forever and ever to there are many a clinical trial that are testing the hypothesis of, “Can we stop treatment? Who needs to be treated? Could we be getting closer to that elusive cure that we all are looking for in myeloma?”

So, to me, the hope is newer drugs that are better tolerated, providing better quality of life for patients. And in a lot of cases, the patients are not even on treatment. That is where we think we are making a change and making a difference. And you had started by asking me, “What is the driving force?” That to me is the driving force of why we get excited to come to work every morning, because we know that we can help someone else, and we can learn something new.

Katherine:

That’s very promising, Dr. Ailawadhi. Thanks so much for taking the time to join us today.

Dr. Ailawadhi:

Absolutely. Thanks a lot for this opportunity.

Katherine:

And thank you to all of our collaborators. To learn more about myeloma and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for being with us today.

Self-Advocacy in Myeloma Care | Advice From an Expert

April 3, 2024/in Evolve Myeloma, Evolve Myeloma Advocacy, MM Newly Diagnosed, MM Programs, MM Videos ND, MM Videos WPS, MM Whole Patient Support, Multiple Myeloma /by Kara Rayburn

Self-Advocacy in Myeloma Care | Advice From an Expert from Patient Empowerment Network on Vimeo.

What questions should myeloma patients ask their doctor about a treatment plan? Myeloma expert Dr. Omar Nadeem shares key advice and emphasizes the importance of patients engaging with their healthcare team in treatment decisions.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Download Resource Guide

See More from Evolve Myeloma

Related Resources:

Clinical Trials for Myeloma Treatment | Essential Information for Patients

What Should Myeloma Patients Ask About Developing Research?

Personalized Medicine for Myeloma Treatment | What Patients Should Know

Transcript:

Katherine:

What questions should patients be asking their provider about a proposed treatment plan?

Dr. Nadeem:

Yeah. I think because myeloma therapy’s so nuanced and much of this is still in clinical trials or under investigation about what to do with some of these results, I would say, as a whole, it’s important to know which tests the physician looks at to determine how you’re doing, and kind of what their assessment of that result is. So, for example, if somebody’s had a 50 percent reduction in the amount of abnormal protein in the blood, is that sufficient, or should we be aiming for a number that’s much higher than that?

Some of that depends on kind of where they are in their treatment course, but that’s a very sort of reasonable question to ask your physician is that where do you see my response now, let’s say six months into therapy, and is this adequate, and what is now, after we have all this information, what is my roadmap going forward to try to keep this disease in check?

Katherine:

Yeah. Well, that’s great advice, Dr. Nadeem. Thank you. I’d like to turn to self-advocacy, Dr. Nadeem. Why is it so important that patients engage in their care treatment decisions?

Dr. Nadeem:

Yeah. As I mentioned, myeloma therapy is so individualized now and we can sit here, look at the trial data, get very into the weeds and technical about this therapy with this approach as X or Y higher response rate.

Or MRD-negative rate, but in reality, we’re dealing with people and we’re dealing with people that have lives.

They have all their priorities, and until you share that with us, it’s very difficult for us to know exactly what’s important to you. So, what I may consider to be kind of the “best therapy” for you may not make sense for you because of all the priorities that you may have, and I think it’s so important to advocate for yourself and not be afraid to bring that up to your physician because I think many patients kind of hold that stuff in for a long time because they don’t want it to impact their care. But I would argue the other way around.

Tell us. Tell us exactly what you prioritize. Tell us if you can’t be out of commission for work for X amount of time because of a stem cell transplant. We now have options. We now have options for patients because of all these amazing new therapies for myeloma and we can come up with a very individualized treatment plan for you based on your priorities.

Katherine:

If a patient is feeling like they’re not getting the best care or they’re uncomfortable with the care they’re receiving, what steps should they take to change that?

Dr. Nadeem:

Yeah, I think that’s very difficult because this is a complex system. Medical systems are getting even more and more complex. They’re busy. Everybody’s busy: busy offices, labs, radiology. We’re all feeling that. It doesn’t matter where you are. So, I think it’s important to raise those concerns, number one, to your practice that you’re being seen at because they would like to see that feedback, right? So, kind of see what is something that they can perhaps improve upon. I think it’s always important, like we just said, to advocate for yourself and raise some of these issues and not be afraid of that.

We’re all in this together, right, so I think ultimately, we’re all trying to take the best care of you and we would need to know which part of that may or may not be working so well.

Personalized Medicine for Myeloma Treatment | What Patients Should Know

April 3, 2024/in Evolve Myeloma, Evolve Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

Personalized Medicine for Myeloma Treatment | What Patients Should Know from Patient Empowerment Network on Vimeo.

What is personalized medicine, and how can myeloma patients access this type of care? Myeloma expert Dr. Omar Nadeem defines personalized medicine and shares how test results can impact myeloma care and treatment options.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Download Resource Guide

See More from Evolve Myeloma

Related Resources:

Self-Advocacy in Myeloma Care | Advice From an Expert

Myeloma Research Highlights From ASH 2023

What Should Myeloma Patients Ask About Developing Research?

Transcript:

Katherine:

Well, Dr. Nadeem, we’ve been hearing the term personalized medicine more frequently in recent years. How would you define personalized medicine for myeloma, and how can patients access this type of care?

Dr. Nadeem:

Yeah, personalized medicine or precision medicine is a term that we’ve really sort of used for many oncologic conditions over the last decade or so. I would say, for multiple myeloma, in terms of identifying a target within the myeloma cell that’s unique to the patient.

And then deploying a certain therapy to that patient because of that target is still lacking. We do have one example where patients have, for example, an 11;14 translocation, which we see in about 15 percent of myeloma patients.

There’s an agent called venetoclax (Venclexta) that is very active against that particular cohort of patients, although that is still not approved to be used, but that’s one example where that agent specifically benefits that type of myeloma. Other than that, most of the therapies that we have benefit essentially everybody with myeloma, which is great, but it’s not so personalized.

Where I would say there’s the most personalization happening now, at least in my practice, is looking at which types of therapies an individual patient may receive. What I mean by that is if somebody’s in an excellent response, with quadruplet-based induction therapy, I have a very real discussion with them about the pros and cons of stem cell transplant.

We make those decisions in real time depending on how the patient doing, depending on how their response is.

And then kind of deciding a whole kind of what are the kind of risks and benefits and what makes sense for that individual patient. Similarly, when you go on to maintenance therapy, maintenance therapy means that after you’ve gone through the initial phase of your myeloma therapy and the disease is under control, what type of therapy can we keep you on to keep it under control for as long as possible? Historically, that has been lenalidomide or Revlimid. Now we’re adding drugs such as daratumamab (Darzalex) and other agents to Revlimid to see if that can further prolong the response to that initial therapy.

So, all those decisions are so individualized that you have to discuss with your provider what makes sense for you and what are the pros and cons of doing one approach versus the other.

Katherine:

Well, if we’re talking about in-depth testing, how do the results of that testing affect treatment options?

Dr. Nadeem:

So, right now we use conventional blood tests to get a sense of response in the vast majority of patients. That includes the serum protein electrophoresis and the serum free light chain assay.

Most patients have detectable levels of these proteins, abnormal proteins in the blood at diagnosis and then you can follow them using a blood test. There’s a subset of patients that have disease only that shows up on scans. So, we then kind of incorporate some of those scans and then, also, utilize the bone marrow results both in the beginning and in subsequent analyses to kind of give a big-picture composite response assessment for that particular patient. Nowadays, there are also other tools that we’re using, such as MRD, or minimal residual disease.

That is a test that is done on a bone marrow biopsy to determine, if you don’t have detectable protein in the blood, do you have myeloma cells present at the deepest level possible? And if you do versus if you don’t, trials have shown that there is a difference in terms of prognosis. Now, while that hasn’t fully been utilized yet to make treatment decisions in patients that are not on clinical trials, we do get prognostic information out of it, and nowadays, more and more of those trials are using these MRD tests to determine what to do with treatment.

And I think that’s how it’s going to be in the future. So, having those extra tests available but, again, important to discuss with your provider what is the utility of this test. How are we going to use this information for your individual case to make some decisions?

Next Generation Myeloma Treatment Options

April 3, 2024/in Evolve Myeloma, Evolve Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

Next Generation Myeloma Treatment Options from Patient Empowerment Network on Vimeo.

What new myeloma therapies are showing promise? Myeloma expert Dr. Omar Nadeem shares an update on emerging myeloma treatment research, including CELMoDs, and shares advice for a having a treatment plan roadmap.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Download Resource Guide

See More from Evolve Myeloma

Related Resources:

Personalized Medicine for Myeloma Treatment | What Patients Should Know

Myeloma Research Highlights From ASH 2023

What Should Myeloma Patients Ask About Developing Research?

Transcript:

Katherine:

Are there other emerging myeloma therapies that are showing promise?

Dr. Nadeem:

Yes. So, I think over the last few years, most of the buzz has been with these immunotherapies. And, again, more work to be done there to see whether combinations, different schedules, different targets, different types, will show more and more benefit in each of these myeloma disease settings.

But we also have simultaneous development of other agents that are not in this sort of immunotherapy T-cell redirecting therapy realm. We have newer versions of our classic immunomodulatory drugs, such as lenalidomide (Revlimid) or pomalidomide (Pomalyst).

We now have their next generation agents, called CELMoD drugs and there’s two of them in development. One of them is called iberdomide; one is called mezigdomide.

These are, again, kind of building up on the success of some of these previous therapies that are kind of cornerstone therapies for myeloma patients and because these are essentially better agents, they’re more targeted, and they also have greater response rates as single agents and as combinations.

We’re hoping that these would be approved in the not-so-distant future and then perhaps will replace some of these immunomodulatory drugs that we have currently utilized in newly diagnosed and relapsed myeloma. Essentially what this means is things are just getting better and better and better as we get newer versions of some of these therapies. So, those are, I would say, kind of next in line in terms of hopeful approvals.

And then we’ll add to some of the options that we have for myeloma patients.

Katherine:

How can patients and care partners stay informed about the latest myeloma research?

Dr. Nadeem:

Yeah, it’s a lot of moving parts all the time. From one six-month interval to the next, you tend to have nowadays perhaps some drug approvals, which is amazing, but if not updates of all these sort of combination trials, etcetera, of where these things are going. I think kind of talking to your physician, obviously, about some of these updates is really critical. As I mentioned before, having a roadmap in your mind about what the myeloma therapy for you might look like going forward, wherever you are in your disease state, is always important because it gives you time to sort of think about it, learn about it, prepare for it.

Some of these therapies really require an effort from the patient and their caregivers because, for example, for CAR-T cells. If you’re not near a center, you may have to relocate for a month.

And it’s very difficult, and we fully understand that and try to help as much as we can, but that’s the kind of commitment that it takes. So, talking to your physician, obviously content like this, reviewing this as much as you can. Online patient support groups are great because you learn from the other patients’ experiences. So, the good news now is we have so many channels of communication, but you have to in a way, in the end, discuss with your physician and verify things you may find on your own.

Katherine:

Exactly, yeah. You want to make sure you’re getting facts rather than fiction.

Dr. Nadeem:

Yeah. That’s right.

Evolving Myeloma Treatment Options | Bispecific Antibody Therapy

April 3, 2024/in Evolve Myeloma, Evolve Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

Evolving Myeloma Treatment Options | Bispecific Antibody Therapy from Patient Empowerment Network on Vimeo.

What are bispecific antibodies, and how are they advancing myeloma care? Dr. Omar Nadeem of Dana-Farber Cancer Institute discusses the role of this new therapy in myeloma care, shares an update on ongoing bispecific antibody research, and compares this treatment to CAR T-cell therapy.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Download Resource Guide

See More from Evolve Myeloma

Related Resources:

What Is the Role of Bispecific Antibody Therapy in the Future of Myeloma Care?

Myeloma Research Highlights From ASH 2023

What Should Myeloma Patients Ask About Developing Research?

Transcript:

Katherine:

Well, another therapy that has emerged in myeloma is bispecific antibodies. What patient type is this therapy right for?

Dr. Nadeem:

So, bispecific antibodies are great because they’re off the shelf. What that means is that CAR-T cells, we first have to collect the T cells and we then have to send them off to be manufactured, and that manufacturing process can take up to a month, sometimes even longer, for some of the current available CAR-T products.

And then, after the cells are returned to the facility, we then give usually three days of chemotherapy to try to suppress some of the immune systems of the patients. So, that way, when the cells are administered, they can expand robustly and do essentially what they need to do.

So, that whole logistical process can take a couple of months by the time you identify somebody for CAR-T cells and then, from that moment until they can actually be treated. With bispecific antibodies, if we think somebody’s ready to go, you can basically get it as soon as we can have somebody ready to go either in our clinic or on the in-patient facility.

So, they’re much easier. They also utilize T cells to attack myeloma cells. We now have three approved bispecific antibodies. Two of them are targeting BCMA, the same exact target that we have in CAR-T cells, and one of them is now targeting a new target called GPRC5D, which is also highly expressed on myeloma cells.

So, having all these bispecific antibodies available is excellent because patients can have access to them a lot faster and now we’re trying to answer the question of sequencing. Can you give bispecific antibodies after CAR-T cells for example? Can you give one bispecific antibody after another, especially if there’s a different target that we now have available?

As a whole, though, bispecific antibodies tend to have lower response rates than CAR-T cells, particularly cilta-cel (Carvykti), which is cilta-cel that has a very high response rate of close to 100 percent.

Most bispecific antibodies have response rates somewhere around 70 or so percent, so about two-thirds of patients respond to these therapies, again, in that fifth line or four or more lines of therapy. So, in that space, that’s the response rate. And across the board, generally speaking, patients benefit from these bispecific antibodies approximately a year on average. Some of the studies have shown longer benefit, and it also depends somewhat on response to therapy.

Patients that have a really deep response can go even way longer than that. So, it is quite mixed in terms of how somebody may do on these bispecific antibodies, but those are the numbers.

Katherine:

Well, it sounds like bispecific antibodies have really transformed myeloma treatment options.

Dr. Nadeem:

Absolutely, and what goes hand in hand in this.

I mentioned the logistics of CAR T, but then there’s also the supply and availability of CAR-T cells. Since the approval, the demand for CAR-T cells has been very high because of all these excellent results, but the supply really hasn’t been there. So, even at a center as busy as ours, we can only treat a handful of patients with CAR T-cell therapies compared to bispecific antibodies, where that is essentially an injection similar to many other approved myeloma agents that you can just readily treat patients with. So, CAR-T cells, while I think, again, have higher efficacy, with that comes slightly higher toxicity as well. It’s a very different kind of treatment program.

And then, patients get a treatment-free interval, which you don’t see yet with bispecific antibodies. On the other hand, bispecific antibodies are readily available, slightly lower response rates, slightly lower toxicity when it comes to at least the traditional T-cell directing toxicities. And then you have, again, the readily available nature of it, which I think is hugely beneficial for patients.

Katherine:

You talked about some specifics regarding bispecific antibodies, but are there updates in bispecific antibody research that you’d like to share?

Dr. Nadeem:

Yeah, so, again, kind of following the theme of what we just said about CAR-T cells, can you bring these antibody therapies earlier? And there’s ongoing trials now looking at it in newly diagnosed multiple myeloma and early relapses, and then we presented our data at ASH this previous year looking at it in high-risk smoldering myeloma. We treated patients with teclistimab (Tecvayli), which is a BCMA bispecific antibody that is approved for relapse refractory patients. And what we demonstrated in that study is that people that got teclistimab had a 100 percent response rate with an MRD-negative rate. So, kind of as deep of a response as we can measure, also at 100 percent.

So, this is something that we had not seen before. When their immune systems are a lot healthier, they may benefit more. So, hopefully we’ll see confirmation of these results in other trials.

Particularly in the newly diagnosed space because we do think that these antibody therapies have such huge potential to treat patients, and then hopefully we’ll have durable responses. So, I do think that some of this paradigm may shift over the next few years, and then there’s also combinations that are currently being studied: combinations with traditional myeloma therapies, such as monoclonal antibodies, other immunomodulatory agents, or proteasome inhibitors. All these combination trials are now ongoing to see can you improve upon some of those numbers that I highlighted before with single-agent bispecific antibody therapy.

Katherine:

Can you share the pros and cons of bispecifics and how it compares to CAR T?”

Dr. Nadeem:

Yeah. I think we mentioned earlier that as a whole, they’re very similar. They’re both T-cell re-directing therapies, in many circumstances, with the same exact target of the myeloma cell, but because this isn’t a cell infusion – this is a cell injection – that you receive that redirects your T cells to the myeloma cells, you tend to see a little bit of a lower toxicity signal when it comes to the cytokine release syndrome incidents and severity. You see lower neurological toxicity, usually, than you do with CAR T-cell products as a whole.

With that comes slightly lower efficacy than you see with at least some of our CAR-T products, but if you respond to therapy, then the durability of response can be as good as you can achieve with CAR-T cells. One thing to note about the bispecifics, though, is that it is continuous therapy, so you are getting it on some regular schedule. Right now the approval is for it to be given weekly and then go to every two weeks after six months of therapy if you’re basically in a good response.

A lot of that is to try to mitigate the risk of infection. So, that is one of the biggest things that we have seen with bispecifics more so than CAR-T cells. Because it is continuous administration of these therapies, that really suppresses your immune system significantly, and infection rates are quite high. So, we typically give other ways to try to mitigate that using immunoglobulin infusions to try to boost up your immune system. Typically, we do that once a month for patients, making sure you’re on the right prophylactic medications and then really adjusting the therapy and the schedule to you depending on your tolerability.

So, as we said before, it’s an excellent option. I think bispecific antibodies are going to be the mainstay of myeloma therapy going forward because CAR-T cells, again, we can’t really treat everybody with CAR-T cells just simply because of the dynamics of how the process is. So, having the bispecific antibodies available for patients is excellent.

Evolving Myeloma Treatment Options | CAR T-Cell Therapy

April 3, 2024/in Evolve Myeloma, Evolve Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

Evolving Myeloma Treatment Options | CAR T-Cell Therapy from Patient Empowerment Network on Vimeo.

What is CAR T-cell therapy, and who is it right for? Dr. Omar Nadeem of Dana-Farber Cancer Institute discusses the role of this therapy in myeloma care and shares an update in ongoing CAR T-cell therapy clinical trial research.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Download Resource Guide

See More from Evolve Myeloma

Related Resources:

Clinical Trials for Myeloma Treatment | Essential Information for Patients

Personalized Medicine for Myeloma Treatment | What Patients Should Know

What Should Myeloma Patients Ask About Developing Research?

Transcript:

Katherine:

Well, I’d like to talk about some new and emerging therapies in myeloma, starting with CAR T-cell therapy. Can you talk about who this treatment option might be appropriate for?

Dr. Nadeem:

So, yeah, just to kind of give folks background, CAR T-cell therapy is a form of immunotherapy, where we take out an individual’s T-cells and then re-program them, essentially, to recognize myeloma cells. Right now there’s two approved CAR-T products for multiple myeloma, both in the relapse refractory setting. It’s really for patients that have had four or more lines of therapy.

So, that’s a lot of different combinations that we currently have available. Those therapies stop working before patients are actually eligible for CAR-T cells at the moment. Both of these CAR T-cell products have been gamechangers in terms of improving prognosis for patients.

The good thing about CAR-T cells is that it is a one-and-done treatment. So, patients, when they go through that initial phase of therapy, they are then off therapy, although we are now starting to study certain therapies that we may administer after CAR-T cells to get them to last even longer than they currently do, but that’s still in, for example, that’s one of the clinical trials or many of the clinical trials that are currently ongoing now, to try to answer that question.

So, a lot of patients can be eligible for CAR-T cells. They have to have the prerequisite amount of therapies. Again, there are some sort of baseline fitness characteristics that we look at for patient’s ability to tolerate it. But as a whole, I consider CAR T-cell therapy more broadly applicable to myeloma patients than compared to, let’s say, a stem cell transplant.

Katherine:

How has this therapy revolutionized myeloma care?

Dr. Nadeem:

Yeah, before the first approval, now a few years ago, in this space we didn’t really have anything like this to offer patients. So, many of the combinations and other compounds that were in clinical trials would have a response rate somewhere around, let’s say, 30 percent. So, 30 percent of patients may respond to that therapy in that space, and that may only last a few months, and that was considered successful not that long ago. Now, with CAR T-cell therapy and bispecific antibodies, these therapies are highly efficacious.

You see response rates of 70 to 100 percent in some of these immunotherapies, and what that’s translating into is patient’s disease staying away for a year or two years, even three years in some of these clinical trials. And again, this is completely unprecedented compared to what we had before.

Katherine:

I understand that there are a number of clinical trials for different types of CAR T, or even using it earlier in the disease. Can you share updates in CAR T-cell therapy research?

Dr. Nadeem:

Yeah, so, exactly as you pointed out, there have been trials already, actually, that have been completed, Phase III studies looking at CAR T-cell therapies in earlier relapses. So, patients that have had either one of two lines of therapy.

Both our CAR-T therapies have been compared to standard of care in that space and have shown superiority, and this is something that we all have been kind of waiting for to see if you deploy it earlier, perhaps you’re going to see even greater benefit, and that seems to be the case in some of these trials, and now we’re awaiting, hopefully, approval of some of these CAR T-cell therapies to be administered earlier because in fifth line, it’s very different than treating patients in second or third line, which I think will really vastly improve our ability to deliver this therapy to many patients, as it can be quite challenging for patients that are in fifth line, to allow them to go through the process of CAR-T cells and then having them be administered.

I was looking at it head-to-head with stem cell transplant, as I mentioned before, and this is in the context of quadruplet and induction therapy followed by either CAR-T cells or stem cell transplant, and then followed by maintenance therapy. So, really trying to see if I can overcome what we typically have achieved with stem cell transplantation.

We also are doing some studies even before that. So, patients, again, in high-risk smoldering myeloma, which we know have an increased risk of developing newly diagnosed disease in the next few years, perhaps that could be the time where we can give some of these immunotherapies, and that’s some work that we have going on at our center.

Clinical Trials for Myeloma Treatment | Essential Information for Patients

April 3, 2024/in Evolve Myeloma, Evolve Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

Clinical Trials for Myeloma Treatment | Essential Information for Patients from Patient Empowerment Network on Vimeo.

How do clinical trials advance treatment options for myeloma? Dr. Omar Nadeem discusses the important role of clinical trials in improving patient care, key questions to ask your care team about trial participation, and the benefits of seeing a myeloma specialist.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Download Resource Guide

See More from Evolve Myeloma

Related Resources:

Next Generation Myeloma Treatment Options

Personalized Medicine for Myeloma Treatment | What Patients Should Know

Myeloma Research Highlights From ASH 2023

Transcript:

Katherine:

I’d like to start with the importance of a patient’s healthcare team. What are the benefits to seeking care with a myeloma specialist, even if it’s just for a second opinion or a consult?

Dr. Nadeem:

Yeah, so, myeloma is a little less than 2 percent of all cancers, and it’s the second most common blood cancer, so certainly not rare. With that being said, if you go to a general community practice, they don’t typically see too, too many patients with this disease. So, alongside that, we have so many different treatment options and combinations and these, as I mentioned, immune therapies.

And other therapies that are only actually carried out at academic centers for now, such as stem cell transplants, and CAR T-cell therapy.

I think it’s important to kind of meet with an academic provider just to get a sense of what the patient may be facing, both in that immediate time, but also in the future, because a lot of myeloma therapy is lifelong. And in that case, you do have to come up with a plan for your whole treatment in a way early. So, it’s important to kind of one: hear it from another person, and then two: really sort of figure out what the outlook would look like for the individual patient.

With that being said, many of our myeloma regimens that are approved can very easily be given at the local provider, and that’s usually our preference, for patients to be treated closer to home. So, ultimately, this is another way for patients to get input about their treatment program, but also talk about the future.

Katherine:

That makes sense. Specialists at academic medical centers are typically more involved in research and clinical trials.

And patient participation is essential to advancing medicine. So, how do clinical trials impact myeloma care?

Dr. Nadeem:

Well, everything that we have available today for myeloma therapy was once in a clinical trial. So, all these promising therapies usually start in early phase studies and move on to Phase II and Phase III studies, and then those are the ones that the FDA uses to approve a particular combination.

So, it all depends on kind of where someone is in their disease course. It also kind of depends on what their preferences may be in terms of taking on something that is beyond standard of care. So, as part of any clinical trial in whatever phase it may be, whether its newly diagnosed multiple myeloma, even smoldering myeloma, which is one step before that, relapsed/refractory myeloma…

At each step of the way, there are clinical trials that are there trying to improve upon what’s already out here, right? So, we are, despite all these amazing advances, unfortunately, the disease is still not curable for a vast majority of patients.

In that case, how do we move to that cure, or how do we kind of advance the disease even beyond this? And a clinical trial is a way to do that.

Katherine:

What type of patient is most appropriate for a clinical trial?

Dr. Nadeem:

So, there are criteria that each clinical trial uses in terms of eligibility. Some of that has to do with the disease characteristic itself, kind of where somebody is in their disease course, but many times it’s also patients’ fitness, organ status in terms of kidney function, their blood count to some extent, heart function, etcetera. There are some sort of minimal prerequisite guidelines that we have to enroll patients in trials. So, it really, again, depends on where somebody is in their disease course and what they may be willing to take on beyond what may be offered to them as part of standard of care.

Katherine:

What questions should patients be asking if they’re entrusted in participating in a clinical trial?

Dr. Nadeem:

I think the important thing is to sort of first recognize what’s available to them as part of standard of care and then what the clinical trial is trying to answer.

So, for example, if it’s newly diagnosed multiple myeloma, we now have quadruplet regimens that we give to patients at the time of their diagnosis, and then the next natural question for eligible patients that now comes up is whether they should do a stem cell transplant or not.

And alongside that goes with all these advances in immune therapies, such as CAR T-cell therapies and bispecific antibodies. And there are now trials looking at those therapies and comparing them, for example, to stem cell transplant to try to answer the question “Can we get even beyond something like a stem cell transplant?”

So, that’s one example of a trial where a patient may be interested in saying “Okay, well, a transplant may be my standard path, but what if I try to enroll in this study and get randomized, for example, to the CAR-T arm? Then, perhaps, I’m getting access to some of these therapies early and maybe that’s going to improve my outcomes.”

Evolving Myeloma Treatment Options: How You Can Access Cutting-Edge Care

March 27, 2024/in Evolve Myeloma, Evolve Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Resources ND, MM Resources TC, MM Treatments and Clinical Trials, Multiple Myeloma /by Kara Rayburn

Evolving Myeloma Treatment Options: How You Can Access Cutting-Edge Care from Patient Empowerment Network on Vimeo.

With the quickly evolving landscape of myeloma treatment and care, it’s important to work with your healthcare team to determine a care plan. In this program, Dr. Omar Nadeem discusses the latest updates in research and clinical trials, the role of new and emerging therapies– including bispecific antibodies and CAR T-cell therapy–and shares advice for accessing quality myeloma care.

Dr. Omar Nadeem is the Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Associate Director of the Multiple Myeloma Clinical Research Program at the Dana-Farber Cancer Institute. Learn more about Dr. Nadeem.

Download Resource Guide

See More from Evolve Myeloma

Related Resources:

What Is the Role of Bispecific Antibody Therapy in the Future of Myeloma Care?

Questions to Ask Your Doctor About CAR T-Cell Therapy

Considering CAR T-Cell Therapy for Myeloma? Key Questions to Ask Your Doctor

Transcript:

Katherine:

Hello, and welcome. I’m your host, Katherine Banwell. As patients collaborate on treatment decisions with their healthcare team, it’s important that they understand all of their options and how these options may be impacted by research developments. That’s why the Patient Empowerment Network created the Evolve series, to arm you with the latest information and help you feel empowered and confident during conversations about your myeloma care.

In today’s program, we’re going to hear from an expert in the field about the evolving treatment landscape and discuss how you can play an active role in your care. Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what may be best for you. Well, let’s meet our guest today. Joining us is Dr. Omar Nadeem. Dr. Nadeem, welcome. Would you please introduce yourself.

Dr. Nadeem:

Thank you. Hi, everyone. My name is Omar Nadeem from the Dana-Farber Cancer Institute. It’s my pleasure to be here.

Katherine:

Thank you so much for joining us today. Before we get into our discussion, would you share with the audience how the field of myeloma care has changed over the course of your career?

Dr. Nadeem:

Yeah, and things are changing so rapidly. My career started after my training in 2015 and at that time, daratumumab (Darzalex) just had its approval in relapsed/refractory multiple myeloma. That, along with several other monoclonal antibodies a few immunomodulatory drugs and proteasome inhibitors.

At that time, it felt like myeloma was at the forefront of significant advances and change in practice, which it was. Little did we know that we were right around the corner with the next renaissance of myeloma therapy, which is these immunotherapies that have been approved over the last three to four years now. So, safe to say things are changing so, so fast and it’s leading to excellent outcomes for patients.

Katherine:

Yeah, it’s great news. So positive. I’d like to start with the importance of a patient’s healthcare team. What are the benefits to seeking care with a myeloma specialist, even if it’s just for a second opinion or a consult?

Dr. Nadeem:

Yeah, so, myeloma is a little less than 2 percent of all cancers, and it’s the second most common blood cancer, so certainly not rare. With that being said, if you go to a general community practice, they don’t typically see too, too many patients with this disease. So, alongside that, we have so many different treatment options and combinations and these, as I mentioned, immune therapies.

And other therapies that are only actually carried out at academic centers for now, such as stem cell transplants, and CAR T-cell therapy. I think it’s important to kind of meet with an academic provider just to get a sense of what the patient may be facing, both in that immediate time, but also in the future, because a lot of myeloma therapy is lifelong. And in that case, you do have to come up with a plan for your whole treatment in a way early. So, it’s important to kind of one: hear it from another person, and then two: really sort of figure out what the outlook would look like for the individual patient.

With that being said, many of our myeloma regimens that are approved can very easily be given at the local provider, and that’s usually our preference, for patients to be treated closer to home. So, ultimately, this is another way for patients to get input about their treatment program, but also talk about the future.

Katherine:

That makes sense. Specialists at academic medical centers are typically more involved in research and clinical trials.

And patient participation is essential to advancing medicine. So, how do clinical trials impact myeloma care?

Dr. Nadeem:

Well, everything that we have available today for myeloma therapy was once in a clinical trial. So, all these promising therapies usually start in early phase studies and move on to Phase II and Phase III studies, and then those are the ones that the FDA uses to approve a particular combination.

So, it all depends on kind of where someone is in their disease course. It also kind of depends on what their preferences may be in terms of taking on something that is beyond standard of care. So, as part of any clinical trial in whatever phase it may be, whether its newly diagnosed multiple myeloma, even smoldering myeloma, which is one step before that, relapsed/refractory myeloma.

At each step of the way, there are clinical trials that are there trying to improve upon what’s already out here, right? So, we are, despite all these amazing advances, unfortunately, the disease is still not curable for a vast majority of patients.

In that case, how do we move to that cure, or how do we kind of advance the disease even beyond this? And a clinical trial is a way to do that.

Katherine:

What type of patient is most appropriate for a clinical trial?

Dr. Nadeem:

So, there are criteria that each clinical trial uses in terms of eligibility. Some of that has to do with the disease characteristic itself, kind of where somebody is in their disease course, but many times it’s also patients’ fitness, organ status in terms of kidney function, their blood count to some extent, heart function, etcetera. There are some sort of minimal prerequisite guidelines that we have to enroll patients in trials. So, it really, again, depends on where somebody is in their disease course and what they may be willing to take on beyond what may be offered to them as part of standard of care.

Katherine:

What questions should patients be asking if they’re entrusted in participating in a clinical trial?

Dr. Nadeem:

I think the important thing is to sort of first recognize what’s available to them as part of standard of care and then what the clinical trial is trying to answer.

So, for example, if it’s newly diagnosed multiple myeloma, we now have quadruplet regimens that we give to patients at the time of their diagnosis, and then the next natural question for eligible patients that now comes up is whether they should do a stem cell transplant or not.

And alongside that goes with all these advances in immune therapies, such as CAR T-cell therapies and bispecific antibodies. And there are now trials looking at those therapies and comparing them, for example, to stem cell transplant to try to answer the question “Can we get even beyond something like a stem cell transplant?”

So, that’s one example of a trial where a patient may be interested in saying “Okay, well, a transplant may be my standard path, but what if I try to enroll in this study and get randomized, for example, to the CAR-T arm? Then, perhaps, I’m getting access to some of these therapies early and maybe that’s going to improve my outcomes.”

Katherine:

Well, I’d like to talk about some new and emerging therapies in myeloma, starting with CAR T-cell therapy. Can you talk about who this treatment option might be appropriate for?

Dr. Nadeem:

So, yeah, just to kind of give folks background, CAR T-cell therapy is a form of immunotherapy, where we take out an individual’s T-cells and then re-program them, essentially, to recognize myeloma cells. Right now there’s two approved CAR-T products for multiple myeloma, both in the relapse refractory setting. It’s really for patients that have had four or more lines of therapy.

So, that’s a lot of different combinations that we currently have available. Those therapies stop working before patients are actually eligible for CAR-T cells at the moment. Both of these CAR T-cell products have been gamechangers in terms of improving prognosis for patients.

The good thing about CAR-T cells is that it is a one-and-done treatment. So, patients, when they go through that initial phase of therapy, they are then off therapy, although we are now starting to study certain therapies that we may administer after CAR-T cells to get them to last even longer than they currently do, but that’s still in, for example, that’s one of the clinical trials or many of the clinical trials that are currently ongoing now, to try to answer that question.

So, a lot of patients can be eligible for CAR-T cells. They have to have the prerequisite amount of therapies. Again, there are some sort of baseline fitness characteristics that we look at for patient’s ability to tolerate it. But as a whole, I consider CAR T-cell therapy more broadly applicable to myeloma patients than compared to, let’s say, a stem cell transplant.

Katherine:

How has this therapy revolutionized myeloma care?

Dr. Nadeem:

Yeah, before the first approval, now a few years ago, in this space we didn’t really have anything like this to offer patients. So, many of the combinations and other compounds that were in clinical trials would have a response rate somewhere around, let’s say, 30 percent. So, 30 percent of patients may respond to that therapy in that space, and that may only last a few months, and that was considered successful not that long ago. Now, with CAR T-cell therapy and bispecific antibodies, these therapies are highly efficacious.

You see response rates of 70 to 100 percent in some of these immunotherapies, and what that’s translating into is patient’s disease staying away for a year or two years, even three years in some of these clinical trials. And again, this is completely unprecedented compared to what we had before.

Katherine:

I understand that there are a number of clinical trials for different types of CAR T, or even using it earlier in the disease. Can you share updates in CAR T-cell therapy research?

Dr. Nadeem:

Yeah, so, exactly as you pointed out, there have been trials already, actually, that have been completed, Phase III studies looking at CAR T-cell therapies in earlier relapses. So, patients that have had either one of two lines of therapy.

Both our CAR-T therapies have been compared to standard of care in that space and have shown superiority, and this is something that we all have been kind of waiting for to see if you deploy it earlier, perhaps you’re going to see even greater benefit, and that seems to be the case in some of these trials, and now we’re awaiting, hopefully, approval of some of these CAR T-cell therapies to be administered earlier because in fifth line, it’s very different than treating patients in second or third line, which I think will really vastly improve our ability to deliver this therapy to many patients, as it can be quite challenging for patients that are in fifth line, to allow them to go through the process of CAR-T cells and then having them be administered.

I was looking at it head-to-head with stem cell transplant, as I mentioned before, and this is in the context of quadruplet and induction therapy followed by either CAR-T cells or stem cell transplant, and then followed by maintenance therapy. So, really trying to see if I can overcome what we typically have achieved with stem cell transplantation.

We also are doing some studies even before that. So, patients, again, in high-risk smoldering myeloma, which we know have an increased risk of developing newly diagnosed disease in the next few years, perhaps that could be the time where we can give some of these immunotherapies, and that’s some work that we have going on at our center.

Katherine:

Well, another therapy that has emerged in myeloma is bispecific antibodies. What patient type is this therapy right for?

Dr. Nadeem:

So, bispecific antibodies are great because they’re off the shelf. What that means is that CAR-T cells, we first have to collect the T cells and we then have to send them off to be manufactured, and that manufacturing process can take up to a month, sometimes even longer, for some of the current available CAR-T products. And then, after the cells are returned to the facility, we then give usually three days of chemotherapy to try to suppress some of the immune systems of the patients. So, that way, when the cells are administered, they can expand robustly and do essentially what they need to do.

So, that whole logistical process can take a couple of months by the time you identify somebody for CAR-T cells and then, from that moment until they can actually be treated. With bispecific antibodies, if we think somebody’s ready to go, you can basically get it as soon as we can have somebody ready to go either in our clinic or on the in-patient facility. So, they’re much easier. They also utilize T cells to attack myeloma cells. We now have three approved bispecific antibodies. Two of them are targeting BCMA, the same exact target that we have in CAR-T cells, and one of them is now targeting a new target called GPRC5D, which is also highly expressed on myeloma cells.

So, having all these bispecific antibodies available is excellent because patients can have access to them a lot faster and now we’re trying to answer the question of sequencing. Can you give bispecific antibodies after CAR-T cells for example? Can you give one bispecific antibody after another, especially if there’s a different target that we now have available?

As a whole, though, bispecific antibodies tend to have lower response rates than CAR-T cells, particularly Cilta-cel (Carvykti), which is cilta-cel that has a very high response rate of close to 100 percent.

Most bispecific antibodies have response rates somewhere around 70 or so percent, so about two-thirds of patients respond to these therapies, again, in that fifth line or four or more lines of therapy. So, in that space, that’s the response rate. And across the board, generally speaking, patients benefit from these bispecific antibodies approximately a year on average. Some of the studies have shown longer benefit, and it also depends somewhat on response to therapy.

Patients that have a really deep response can go even way longer than that. So, it is quite mixed in terms of how somebody may do on these bispecific antibodies, but those are the numbers.

Katherine:

Well, it sounds like bispecific antibodies have really transformed myeloma treatment options.

Dr. Nadeem:

Absolutely, and what goes hand in hand in this.

I mentioned the logistics of CAR T, but then there’s also the supply and availability of CAR-T cells. Since the approval, the demand for CAR-T cells has been very high because of all these excellent results, but the supply really hasn’t been there. So, even at a center as busy as ours, we can only treat a handful of patients with CAR T-cell therapies compared to bispecific antibodies, where that is essentially an injection similar to many other approved myeloma agents that you can just readily treat patients with. So, CAR-T cells, while I think, again, have higher efficacy, with that comes slightly higher toxicity as well. It’s a very different kind of treatment program.

And then, patients get a treatment-free interval, which you don’t see yet with bispecific antibodies. On the other hand, bispecific antibodies are readily available, slightly lower response rates, slightly lower toxicity when it comes to at least the traditional T-cell directing toxicities. And then you have, again, the readily available nature of it, which I think is hugely beneficial for patients.

Katherine:

You talked about some specifics regarding bispecific antibodies, but are there updates in bispecific antibody research that you’d like to share?

Dr. Nadeem:

Yeah, so, again, kind of following the theme of what we just said about CAR-T cells, can you bring these antibody therapies earlier? And there’s ongoing trials now looking at it in newly diagnosed multiple myeloma and early relapses, and then we presented our data at ASH this previous year looking at it in high-risk smoldering myeloma. We treated patients with teclistimab (Tecvayli), which is a BCMA bispecific antibody that is approved for relapse refractory patients. And what we demonstrated in that study is that people that got Teclistimab had a 100 percent response rate with an MRD-negative rate. So, kind of as deep of a response as we can measure, also at 100 percent.

So, this is something that we had not seen before. When their immune systems are a lot healthier, they may benefit more. So, hopefully we’ll see confirmation of these results in other trials.

Particularly in the newly diagnosed space because we do think that these antibody therapies have such huge potential to treat patients, and then hopefully we’ll have durable responses. So, I do think that some of this paradigm may shift over the next few years, and then there’s also combinations that are currently being studied: combinations with traditional myeloma therapies, such as monoclonal antibodies, other immunomodulatory agents, or proteasome inhibitors. All these combination trials are now ongoing to see can you improve upon some of those numbers that I highlighted before with single-agent bispecific antibody therapy.

Katherine:

Oh, I was just going to ask you the next question, which is are there other emerging myeloma therapies that are showing promise?

Dr. Nadeem:

Yes. So, I think over the last few years, most of the buzz has been with these immunotherapies. And, again, more work to be done there to see whether combinations, different schedules, different targets, different types, will show more and more benefit in each of these myeloma disease settings.

But we also have simultaneous development of other agents that are not in this sort of immunotherapy T-cell redirecting therapy realm. We have newer versions of our classic immunomodulatory drugs, such as lenalidomide (Revlimid) or pomalidomide (Pomalyst).

We now have their next generation agents, called CELMoD drugs and there’s two of them in development. One of them is called iberdomide; one is called mezigdomide.

These are, again, kind of building up on the success of some of these previous therapies that are kind of cornerstone therapies for myeloma patients and because these are essentially better agents, they’re more targeted, and they also have greater response rates as single agents and as combinations.

We’re hoping that these would be approved in the not-so-distant future and then perhaps will replace some of these immunomodulatory drugs that we have currently utilized in newly diagnosed and relapsed myeloma. Essentially what this means is things are just getting better and better and better as we get newer versions of some of these therapies. So, those are, I would say, kind of next in line in terms of hopeful approvals.

And then we’ll add to some of the options that we have for myeloma patients.

Katherine:

How can patients and care partners stay informed about the latest myeloma research?

Dr. Nadeem:

Yeah, it’s a lot of moving parts all the time. From one six-month interval to the next, you tend to have nowadays perhaps some drug approvals, which is amazing, but if not updates of all these sort of combination trials, etcetera, of where these things are going. I think kind of talking to your physician, obviously, about some of these updates is really critical. As I mentioned before, having a roadmap in your mind about what the myeloma therapy for you might look like going forward, wherever you are in your disease state, is always important because it gives you time to sort of think about it, learn about it, prepare for it.

Some of these therapies really require an effort from the patient and their caregivers because, for example, for CAR-T cells. If you’re not near a center, you may have to relocate for a month.

And it’s very difficult, and we fully understand that and try to help as much as we can, but that’s the kind of commitment that it takes. So, talking to your physician, obviously content like this, reviewing this as much as you can. Online patient support groups are great because you learn from the other patients’ experiences. So, the good news now is we have so many channels of communication, but you have to in a way, in the end, discuss with your physician and verify things you may find on your own.

Katherine:

Exactly, yeah. You want to make sure you’re getting facts rather than fiction.

Dr. Nadeem:

Yeah. That’s right.

Katherine:

Well, Dr. Nadeem, we’ve been hearing the term personalized medicine more frequently in recent years. How would you define personalized medicine for myeloma, and how can patients access this type of care?

Dr. Nadeem:

Yeah, personalized medicine or precision medicine is a term that we’ve really sort of used for many oncologic conditions over the last decade or so. I would say, for multiple myeloma, in terms of identifying a target within the myeloma cell that’s unique to the patient.

And then deploying a certain therapy to that patient because of that target is still lacking. We do have one example where patients have, for example, an 11;14 translocation, which we see in about 15 percent of myeloma patients.

There’s an agent called venetoclax (Venclexta) that is very active against that particular cohort of patients, although that is still not approved to be used, but that’s one example where that agent specifically benefits that type of myeloma. Other than that, most of the therapies that we have benefit essentially everybody with myeloma, which is great, but it’s not so personalized.

Where I would say there’s the most personalization happening now, at least in my practice, is looking at which types of therapies an individual patient may receive. What I mean by that is if somebody’s in an excellent response, with quadruplet-based induction therapy, I have a very real discussion with them about the pros and cons of stem cell transplant. We make those decisions in real time depending on how the patient doing, depending on how their response is.

And then kind of deciding a whole kind of what are the kind of risks and benefits and what makes sense for that individual patient. Similarly, when you go on to maintenance therapy, maintenance therapy means that after you’ve gone through the initial phase of your myeloma therapy and the disease is under control, what type of therapy can we keep you on to keep it under control for as long as possible? Historically, that has been lenalidomide or Revlimid. Now we’re adding drugs such as daratumamab and other agents to Revlimid to see if that can further prolong the response to that initial therapy.

So, all those decisions are so individualized that you have to discuss with your provider what makes sense for you and what are the pros and cons of doing one approach versus the other.

Katherine:

Well, if we’re talking about in-depth testing, how do the results of that testing affect treatment options?

Dr. Nadeem:

So, right now we use conventional blood tests to get a sense of response in the vast majority of patients. That includes the serum protein electrophoresis and the serum free light chain assay.

Most patients have detectable levels of these proteins, abnormal proteins in the blood at diagnosis and then you can follow them using a blood test. There’s a subset of patients that have disease only that shows up on scans. So, we then kind of incorporate some of those scans and then, also, utilize the bone marrow results both in the beginning and in subsequent analyses to kind of give a big-picture composite response assessment for that particular patient. Nowadays, there are also other tools that we’re using, such as MRD, or minimal residual disease.

That is a test that is done on a bone marrow biopsy to determine, if you don’t have detectable protein in the blood, do you have myeloma cells present at the deepest level possible? And if you do versus if you don’t, trials have shown that there is a difference in terms of prognosis. Now, while that hasn’t fully been utilized yet to make treatment decisions in patients that are not on clinical trials, we do get prognostic information out of it, and nowadays, more and more of those trials are using these MRD tests to determine what to do with treatment.

And I think that’s how it’s going to be in the future. So, having those extra tests available but, again, important to discuss with your provider what is the utility of this test. How are we going to use this information for your individual case to make some decisions?

Katherine:

What questions should patients be asking their provider about a proposed treatment plan?

Dr. Nadeem:

Yeah. I think because myeloma therapy’s so nuanced and much of this is still in clinical trials or under investigation about what to do with some of these results, I would say, as a whole, it’s important to know which tests the physician looks at to determine how you’re doing, and kind of what their assessment of that result is. So, for example, if somebody’s had a 50 percent reduction in the amount of abnormal protein in the blood, is that sufficient, or should we be aiming for a number that’s much higher than that?

Some of that depends on kind of where they are in their treatment course, but that’s a very sort of reasonable question to ask your physician is that where do you see my response now, let’s say six months into therapy, and is this adequate, and what is now, after we have all this information, what is my roadmap going forward to try to keep this disease in check?

Katherine:

Yeah. Well, that’s great advice, Dr. Nadeem. Thank you. PEN has also created a downloadable office visit planner to help you organize your thoughts and communicate effectively with your healthcare team. You can find these at Powerfulpatients.org/myeloma.

I’d like to turn to self-advocacy, Dr. Nadeem. Why is it so important that patients engage in their care treatment decisions?

Dr. Nadeem:

Yeah. As I mentioned, myeloma therapy is so individualized now and we can sit here, look at the trial data, get very into the weeds and technical about this therapy with this approach as X or Y higher response rate.

Or MRD-negative rate, but in reality, we’re dealing with people and we’re dealing with people that have lives. They have all their priorities, and until you share that with us, it’s very difficult for us to know exactly what’s important to you. So, what I may consider to be kind of the “best therapy” for you may not make sense for you because of all the priorities that you may have, and I think it’s so important to advocate for yourself and not be afraid to bring that up to your physician because I think many patients kind of hold that stuff in for a long time because they don’t want it to impact their care. But I would argue the other way around.

Tell us. Tell us exactly what you prioritize. Tell us if you can’t be out of commission for work for X amount of time because of a stem cell transplant. We now have options. We now have options for patients because of all these amazing new therapies for myeloma and we can come up with a very individualized treatment plan for you based on your priorities.

Katherine:

If a patient is feeling like they’re not getting the best care or they’re uncomfortable with the care they’re receiving, what steps should they take to change that?

Dr. Nadeem:

Yeah, I think that’s very difficult because this is a complex system. Medical systems are getting even more and more complex. They’re busy. Everybody’s busy: busy offices, labs, radiology. We’re all feeling that. It doesn’t matter where you are. So, I think it’s important to raise those concerns, number one, to your practice that you’re being seen at because they would like to see that feedback, right? So, kind of see what is something that they can perhaps improve upon. I think it’s always important, like we just said, to advocate for yourself and raise some of these issues and not be afraid of that.

We’re all in this together, right, so I think ultimately, we’re all trying to take the best care of you and we would need to know which part of that may or may not be working so well.

Katherine:

Let’s get to a few audience questions that we received prior to the program. This one is from Rita. “Is there an age limit on CAR T-cell therapy?”

Dr. Nadeem:

So, no, there isn’t. A lot of age-related cutoffs that we’ve historically used for transplants or even the CAR T originally don’t really apply because we all know there’s patients that are in their late 70s that may be more fit and robust than somebody in their 50s. We see this all the time. So, frailty is something that we assess quite a bit in patients in determining whether they can handle some of the toxicities that may come from these therapies. So, there’s no age cutoff.

Again, we look at certain other medical problems you may have, how fit you are, your organ function and things like that, but ultimately the goal is can you tolerate the chemotherapy you get before CAR-T cells and then can you tolerate some of the acute toxicities of CAR-T cells, such as the cytokine release syndrome, some risk of neurological toxicity, things like that. All of those are usually short-term, and if you feel confident that we can get you through that, then you’re eligible.

Katherine:

Yeah. Laura sent in this question: “I’m considering bispecific antibody therapy. I know some of the side effects are similar to CAR T-cell therapy. Can you share the pros and cons of bispecifics and how it compares to CAR T?”

Dr. Nadeem:

Yeah. I think we mentioned earlier that as a whole, they’re very similar. They’re both T-cell re-directing therapies, in many circumstances, with the same exact target of the myeloma cell, but because this isn’t a cell infusion – this is a cell injection – that you receive that redirects your T cells to the myeloma cells, you tend to see a little bit of a lower toxicity signal when it comes to the cytokine release syndrome incidents and severity. You see lower neurological toxicity, usually, than you do with CAR T-cell products as a whole.

With that comes slightly lower efficacy than you see with at least some of our CAR-T products, but if you respond to therapy, then the durability of response can be as good as you can achieve with CAR-T cells. One thing to note about the bispecifics, though, is that it is continuous therapy, so you are getting it on some regular schedule. Right now the approval is for it to be given weekly and then go to every two weeks after six months of therapy if you’re basically in a good response.

A lot of that is to try to mitigate the risk of infection. So, that is one of the biggest things that we have seen with bispecifics more so than CAR-T cells. Because it is continuous administration of these therapies, that really suppresses your immune system significantly, and infection rates are quite high. So, we typically give other ways to try to mitigate that using immunoglobulin infusions to try to boost up your immune system. Typically, we do that once a month for patients, making sure you’re on the right prophylactic medications and then really adjusting the therapy and the schedule to you depending on your tolerability.

So, as we said before, it’s an excellent option. I think bispecific antibodies are going to be the mainstay of myeloma therapy going forward because CAR-T cells, again, we can’t really treat everybody with CAR-T cells just simply because of the dynamics of how the process is. So, having the bispecific antibodies available for patients is excellent.

Katherine:

Thank you for this information, Dr. Nadeem. And please continue to send in your questions to questions@powerfulpatients.org and we’ll work to get them answered on future programs.

We’ve definitely learned today that the field of myeloma care is advancing quickly. As we close out the program, what would you like to leave the audience with? Why are you hopeful?

Dr. Nadeem:

Yeah. I think you all can see the tremendous progress that’s been made and, again, I still think it’s sort of the tip of the iceberg. These immunotherapies that are really showing this kind of activity, we’re just learning about them, and we’re going to improve them, not just the way we administer them. We’re going to make them even better and better and better and our hope is that a cure is not so far in the future. And perhaps even now we can cure a subset of patients if we deploy some of these therapies in the right person at the right time. So, I think that is really what I am hopeful for, that we have all these options available.

Now it’s up to us to figure out which one fits in where and then, as we do that, hopefully we’ll see even better and better outcomes. And my hope is, over time, that this is a disease that we can cure at least in a subset of patients, which means that they get fixed duration therapy with whatever that we have.

And then they’re done, and then hopefully never have to have therapy for this disease because it’ll be gone, and then, in patients that develop a disease relapse, we then treat them with some of these other agents. So, this is starting to hopefully mirror what we see in other blood cancers, such as lymphoma, for example, where you give the initial therapy and cure a subset of patients. Hopefully we can get there with myeloma in the not-so-distant future.

Katherine:

It’s a very promising outlook to leave our audience with. Dr. Nadeem, thank you so much for joining us today.

Dr. Nadeem:

Thank you so much for having me.

Katherine:

And thank you to all of our collaborators. To learn more about myeloma and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for joining us today.

PODCAST: Thrive | Considering CAR T-Cell Therapy for Myeloma? What You Should Know

March 20, 2024/in Empowered! Podcast, MM Podcasts TC, MM Treatments and Clinical Trials, Multiple Myeloma /by Kara Rayburn

Dr. Beth Faiman, a myeloma expert and researcher, discusses factors that should be considered when deciding to undergo CAR T-cell therapy, advice for preparing for and after the process, and why a good support team is essential. Dr. Faiman also shares research updates in CAR T-cell therapy, and alternatives options to this myeloma treatment.

Dr. Beth Faiman is an Adult Nurse Practitioner in the department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic. Learn more about Dr. Faiman.

See More From Thrive CAR T-Cell Therapy

Download Resource Guide

Transcript:

Katherine Banwell:

Welcome. I’m your host, Katherine Banwell. As patients navigate their myeloma care, it’s essential for them to feel formed when engaging with their care team. That’s why the Patient Empowerment Network developed the Thrive series, to share support and educational resources so that patients can feel confident at every stage of their care. In today’s program, we’re going to hear from a renowned myeloma expert as we discuss CAR-T therapy. Before we meet today’s guest, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you.

Well, joining us today is Dr. Beth Faiman. Dr. Faiman, welcome. Would you please introduce yourself?

Dr. Beth Faiman:

Thank you so much, Katherine, and it’s such an honor and a pleasure to be here today. My name is Beth Faiman. I am a nurse practitioner and a PhD researcher at the Cleveland Clinic in Cleveland, Ohio, where I have worked since 1994, in the field of myeloma mostly. Thank you.

Katherine Banwell:

Excellent. Thank you so much for joining us today. As I mentioned, today’s program is part of our Thrive series. So, from your perspective, what does it mean to thrive with myeloma?

Dr. Beth Faiman:

So, to thrive with myeloma is something that when I started managing patients in the 1990s individuals didn’t live very long, maybe two to three years, because we did not have good therapies. Now, we talk about living well with myeloma, thriving with myeloma. It just makes me so happy. I think for plants. I think of flowers that can grow in the right environment. I had a plant in my office recently that somebody had gifted me, and it sat there and tried to soak up the little bit of sunlight that it could muster and just wasn’t doing well.

So, I brought it home and I put it in a big window. That plant is beautiful now and I just love looking at it and thinking about it. And it reminds me of how if you’re in your right environment with multiple myeloma you surround yourself with friends, families, coworkers, church friends, or places of worship, then you can really thrive in that environment or you can grow. And even though you have a cancer diagnosis, that is not – and I hate to use the D-word – a death sentence anymore. You can live many years and live well with myeloma in the right environment like my little plant.

Katherine Banwell:

That’s a great idea to think about. Thank you. Well, we’ve covered this in recent webinars but it’s worth sharing again. Can you give us an overview of the process and timeline for someone choosing CAR T-cell therapy for myeloma treatment?

Dr. Beth Faiman:

Yes. So, CAR T-cell therapy, when we first started discussing this in the mid-2000s, I thought this was science fiction.

Taking somebody’s own cells, engineering them to be fighters against the cancer cells. I thought it was science fiction. But now, we have two FDA approved therapies for multiple myeloma. It’s Ide-cel, which was approved in 2021 and Cilta-cel, approved in 2022.

Now, the process is lengthy and I know you’ve covered this before but from my perspective, I think if you want to take something home form this webinar, plan early. So, you need to have three prior lines of therapy as a myeloma patient to qualify for this treatment. But you can start planning for it ahead of time.

So, it’s not available in every center. So, you want to start researching what the closest center would be for you to have this therapy. Many different patient support networks will have these centers on their websites. So anyhow, you find out.

“Okay. I want to learn more about a CAR T-cell therapy.” Then you have to meet with a specialist. So, you get that education, have that referral, and meet with a specialist at a center that does CAR T-cell therapy. And that might be where you got your initial transplant if you’ve then returned to the community. After that, then we find a slot for you when it’s ready. So, there is that process of financial, physical, social things that are checked in the background. You meet with a social worker, nurses, etc.

Once you’ve confirmed that you’re going to go through this process – now, it might be three, six, nine months in the future, if you’re a planner – but if you want to just gain information, it’s that harvesting and storing of the cells. That’s where I try to tell people age is not a number. You can be at any age and you qualify for this therapy. We’ve had people well into their late 70s to early 80s who have gotten these therapies.

Long story short, it’s a process.

You get your cells harvested and then while they’re being manufactured into fighters, they take the T cells from your blood through an apheresis machine and freeze them, send them off, make them into fighters, and then reinfuse them in your bloodstream. It’s a long process. It can take anywhere from two to three months from when you decide it’s right for you.

Katherine Banwell:

Well, thank you for explaining that. That’s really important. It puts into perspective. It’s a big undertaking. But also, quite manageable, I think, right, with the right team and support. Who are the members?

Dr. Beth Faiman:

Absolutely. The family members, friends, and, of course – I like to use the words the multidisciplinary team. That’s your physicians, your social workers, nurses, nurse practitioners like me, pharmacists, and then all your other specialists.

So really, mounting that team from diagnosis and throughout your whole journey as a myeloma patient can really enrichen your life and help you thrive in that environment.

Katherine Banwell:

Yeah. It sounds like there’s a lot of support for someone going through this process and that the care partner also plays a critical role on the care team, right?

Dr. Beth Faiman:

Oh, absolutely. So, I am a big advocate for care partner though not everybody has a caregiver. So, it can be a formal caregiver, somebody’s spouse, daughter, son, significant other. Or it can be an informal caregiver. So, I’ve had patients that – because you need to have a care partner to qualify for CAR T-cell therapy, because patients need to be monitored for about 30 days afterwards. So, that might be pulling in friends from your place of worship, people from the community, and then also people from the cancer center.

Some of the larger centers that do the CART-cell therapy have a network setup where you get this list of people that have volunteered to drive you to appointments or maybe arrange for Uber help to drive you back and forth. I am not plugging Uber or Lyft, but a rideshare company. And so, finding out those resources can help anyone – just about anyone – access these CAR T-cell therapies, because you can have a long-term remission. Think about somebody who’s been through treatment A, B, C, or D and then now, “Gosh, maybe my life is going to be shortened.”

Not necessarily. If this is the right recipe to control their myeloma then they can get 11, 24 months off of everything – just antibiotics – and be monitored. And so, it puts them at a position where if you can get the care partner, get a care team, to support you then you can have access to a potentially life extending with good quality of life therapy.

Katherine Banwell:

Yeah. I’m sure many of our viewers today are wondering who the therapy is right for and when is it most appropriate in the course of myeloma? Could you address that?

Dr. Beth Faiman:

Yeah, absolutely. So, currently, you have to have had three prior lines of therapy with drugs such as a CD38, which is – daratumumab (Darzalex) is a name of a medication.

You have to have a drug such as lenalidomide (Revlimid) as well as a drug like bortezomib (Velcade). And you have to have had three lines of therapy. So, that’s how you can access the therapy. But if you’re willing to participate in a well-designed clinical trial there are studies with CAR T-cell therapy earlier on.

So, one of the things that we’re advocating in the myeloma world is clinical trials. We haven’t gotten to where we are in 2024 with the advances in sciences, the advances in living longer and living well with myeloma, without the brave people before us that have participated in clinical trials.

So, people who it’s right for would be if they qualify for a clinical trial before their third or fourth line of therapy or if they’ve had three or four prior lines of therapy. And there are other points to that which I’m sure we’ll talk about later on.

Katherine Banwell:

In your opinion, what are three key considerations that myeloma patients and care partners should think about related to the CAR T-cell therapy approach?

Dr. Beth Faiman:

Oh, gosh. Well, I would like to say that always when you’re selecting a therapy, think of the physical, the financial, and the social implications of that therapy. So, physically is the medication too strong for you? Are you too weak to take it? Or is it just right for you? So, finding the right medication for the right patient at the right dose at the right time. So, the physical component. The financial component is also very important. So, maybe your insurance now won’t cover it but then there’s open enrollment in Medicare towards the end of the year or you can find financial support reimbursement through many of our generous organizations that will provide grants for certain medications.

And then, the social. Do you have a care partner, as we discussed? The importance of being monitored for 30 days. If you don’t have a formal care partner, is there some system that we can help support you through so that you can have the different supports throughout. It’s not only that beginning part where you’re gaining the information – and I think of it like a timeline. The beginning part, you’re thinking about gathering information to the – in that process of getting yourselves back because of the side effects, which I think have been talked about in a prior webinar.

And then, the post-monitoring where you go back to your community, taking antibiotics, antiviral medications, etc., to keep you living well longer. So, it’s a process.

Katherine Banwell:

Well, it’s great advice, Dr. Faiman, thank you. I’d also like to add that if you’re considering CAR T-cell therapy, the Patient Empowerment Network has a wealth of information on this topic, including resource guides and interviews with experts like Dr. Faiman.

And you can find those at powerfulpatients.org/myeloma. So, Dr. Faiman, when a patient is talking with their care team about CAR T-cell therapy, what questions should they be asking to help determine if CAR-T is even right for them?

Dr. Beth Faiman:

Katherine, that’s an excellent question. So, let’s just say that somebody from Patient Empowerment Network heard about CAR T-cell therapy for myeloma and then sought out a local institution that might be conducting that procedure. So then, they come for that visit and what you mentioned was just spot on, getting a list of questions together. What we do at my institution, as well as many throughout the country, is a process called shared decision-making.

You might’ve talked about this on prior webinars, but shared decision-making occurs when that healthcare team, such as the physician, nurse practitioner, pharmacist, whoever, shares information with the patient and their care partner.

You mutually share information to arrive at a decision. So, many studies have been done on shared decision-making. It’s done in many different areas. And so, through that sharing of information, you might think of different questions.

Some of the things that I try to proactively offer – we all have our list of things that we educate our patients on, but some of the things I proactively will recommend to patients and their care partners when you’re seeking an opinion at these centers is, “How long will I be sick? What are the biggest side effects of the medication I have to worry about?” Asking your care team – I know it sounds silly, but are they aware of all your prior health concerns, especially if you’re coming for an evaluation.

Maybe you have peripheral neuropathy where you have numbness and tingling in your fingers or toes or a history of kidney disease. Your kidneys look fine now but maybe a few years ago at the myeloma diagnosis the kidneys had a temporary failing and now they’re better so they’d want to protect you with future medications. How long will you have to take medications after the CAR-T procedure? There’s antiviral medicines, antibacterial medications, and medications called IVIG, which strengthens your immune system.

And then, finally, asking about the infection protection afterwards. Do you have to get vaccinated again against pneumococcal, shingles, and all of those other things that we do. The cellular therapy guidelines suggest timepoint for one, three, five, etc., months after CAR T-cell procedure to get revaccinated. So, who’s going to do that for you?

How are you going to know what to get? So, make sure that they give you a timeline, calendars, and set expectations for what you need to do as a patient and then you’ll help them set expectations for what they need to do to provide you the accurate education.

Katherine Banwell:

Well, talking about what to expect after CAR T-cell therapy, would you tell us what some of the potential side effects are?

Dr. Beth Faiman:

Oh, absolutely. So, CAR T-cell therapy – again, it harnesses your immune system using your T cells. Your T cells are so important in your immune system to be programmed as fighters. And as people age, or as long as – after they’ve had myeloma or other kinds of cancers, those T cells just don’t work as well. So, what we want to do is engineer them and program them with what we call a viral vector to be fighters. So, those T cells, as I mentioned, are harvested, stored, and then manufactured to go.

And I tell people it’s like that Pac-Man video game. It goes around in your bloodstream just kind of eating away at the myeloma cells. So, you don’t take any medications. You don’t go in for IVs every week or twice weekly, or taking pills at home to treat the myeloma. It’s what we consider a one-and-done thing. So, if it works for you, it can keep you in remission for quite some time. But if it doesn’t work then there still are other therapies down the road.

So, the CAR T-cell therapy is something that is an option but there are other therapies out there in many cases. There’s something called a bispecific antibody. There are three currently approved for multiple myeloma now. So, maybe a CAR T-cell therapy doesn’t seem right for you because you’re not in a good remission or the cancer’s too active right now so you don’t have the time to wait for manufacturing of the cells and putting them back in your bloodstream.

Those bispecifics will fill that gap. So, when you’re discussing the options, aside from clinical trials and other drugs, the bispecific antibody is very similar. One of the things that I wanted to highlight is that nowadays we’re into these things called sequencing. So, we’re trying to figure out what order to give these super effective drugs. Should we give the bispecific antibodies first or should we give the CAR T-cell therapy first? And in most centers, if you have time to wait and you’re planning, the CAR T-cell therapy is right for most people and then the bispecifics would come later.

Katherine Banwell:

All right. So, after CAR T-cell therapy is completed, what potential side effects might people experience, and what should they look for?

Dr. Beth Faiman:

Absolutely. I think of things in short-term and long-term side effects. So, the short term, you’re going to be admitted to the hospital and you have a risk for – when we get those T cells back – that cytokine release syndrome, or it’s abbreviated CRS – where you’re body’s immune system’s fighting.

I tell folks it’s kind of like if you got a vaccine for a flu vaccine or pneumonia and you had a reaction it’s just way worse. So, you can get a high fever – the big first sign of this CRS. Usually, the providers will jump in with giving you a medication called tocilizumab (Actemra) or a similar drug that blocks IL-6, which is a chemical that is triggered when we get the CRS. And then, it stops those symptoms. And so, most of us know how to do that and will approve your insurance to get access to that tocilizumab or similar drug when we approve your CAR T-cell therapy.

So, that CRS can get you really, really sick. You can get low oxygen levels in your blood. You can get a high fever and you can drop your blood pressure. But most CAR T-cells centers, the nurses and the staff are very well-trained to monitor this every eight hours, in most cases.

Another rare side effect we worry about is ICANS and it’s a neurotoxicity kind of thing.

It can be with CRS or without CRS. But they’ll ask you to do things like write your name on a piece of paper every eight hours or tell me – draw a clock or count backwards from 100. And so, if you have any deviation, even minor, from what you reported back beforehand then we worry about neurotoxicity. Now, that’s short term but that’s the reason why you can’t drive a car for 30 days is because it could be delayed.

The CRS can start with the one thing, the ide-cel usually occurs within one day so most people are admitted to the hospital for that CAR T-cell therapy. The Cilta-cel, it onsets to about seven days. So, some people get the cilta-cel outpatient and then are monitored daily, whether in person or through virtual telehealth monitoring.

But at any rate, those are the short-term. Long-term, we worry about low blood counts maybe for the first month afterwards. And then, those will come back to normal. And then, we worry about infection. So, I mentioned the antibacterial, antiviral, which is usually a medicine called acyclovir (Zovirax), which most myeloma patients will have been on anyhow. And then, that IVIG to protect against viruses and bacteria when your immune system is so low.

But fortunately, if we control the CRS, it usually comes with the CRS, although it can be independent. We try not to give steroids, because we don’t want it to interrupt the CAR T-cell process. But many institutions will give that tocilizumab for ICANS. And if that doesn’t get better then they’ll give you a steroid, such as dexamethasone (Decadron).

And so, that will usually reverse itself pretty quickly. Longer term, after 30 days, you can get with the Carvykti, particularly something called Parkinsonian things where you can get a little bit shaky or something like that. Again, it’s very rare and I have had hundreds of people who have undergone the CAR T-cell procedure at my institution. And knock on wood, fortunately, I’ve not seen first-hand that side effect. And I think it’s because we’re so good now at treating the – preventing the ICANS and CRS as best as we can while they’re inpatient and doing real close following.

One other thing I want to note is if somebody who’s watching this does go in the hospital for any reason, get up and walk around and stay strong, as well as you can, during the procedure. You might be bored if you’re in the hospital anyhow, but try to stay as strong as you can in the hospital. It’ll help your post recovery for sure.

Katherine Banwell:

Well, what about more mild side effects like fatigue and changes in appetite?

Dr. Beth Faiman:

Absolutely. So, the fatigue and the changes in appetite are generally mild for most but I see it, in my experience, if your myeloma’s acting up really quickly, if you’re having a rapid disease progression, the medications that we give you to control the myeloma during this bridging therapy phase might cause some of that as well, not necessarily the CAR T-cell process. But think about it. We’re using your own cells engineered to be fighters.

And so, that first month or two is probably when you’re going to be the most tired as your body is being programmed to fight against the myeloma cells. That fatigue tends to get better. And as I mentioned just a moment earlier, the importance of just walking around in the halls, getting out of bed when you’re in the hospital, that can really help your post recovery. It doesn’t seem like much, but there have been many studies about how muscle mass declines, energy declines when you’re hospitalized.

And we want you to be as strong as you can and thrive as much as you can for when you’re out you can then do the things you want to do at a quicker pace.

Katherine Banwell:

Right. That’s great advice. Beyond monitoring of any issues, what can someone expect related to returning to life as they knew it before the diagnosis? Is there a timeline for resuming lifestyle and activity?

Dr. Beth Faiman:

Yeah. So, I should say I because it’s from my perspective. I am a real strong advocate. I tell people to do what you feel like you can physically do. We know that myeloma can affect the bones and put your bones at risk for breaking and so we give you medicines to protect it. So, I do put some restrictions however on physical activity in terms of, “I don’t want you to bench press 40 pounds or 20 pounds,” in most cases. And depending on what the bones look like on x-ray, I’ll even restrict it to about five to 10 pounds.

If you think about it, that’s a bag of potatoes. So, you don’t want to put too many restrictions on for everybody. But talk to your healthcare provider about what your specific restrictions are with physical activity. Because I don’t really put any restrictions on but I encourage things like riding a bike, especially a stationary bike in your own home, so that if you fall off – hopefully, you won’t fall off a stationary bike. But if you injure yourself, then you’re able to be in a place that somebody can help you.

But riding a bike. Also, exercising in water. Water therapy is a great weight bearing exercise and there are times of day where you can go when the YMCAs or YWCAs aren’t as busy – or community centers. So, you’re less at risk for bacterial or other illnesses. But during that first month, I try to limit their exposure to people because you’re at risk for the different viruses that are all over the place, the bacterial infections.

So, that first month is the critical period where I try to say, “Okay, try to lay low. Let’s get you through this period. Your immune system will start getting stronger on its own after this period.” And then, that month two you start feeling like doing more. You go to the grocery store. You maybe go to eat out at a restaurant but pick a time of day that’s less busy. So, go for an early dinner. There’s no shame in eating at 5:00 p.m. if you want to go out. And then, get a table in the corner with your own wipes. And so, that’s where your immune system is getting stronger.

And then, by month three, I think most people will feel much, much better and much, much stronger. And if you can keep moving throughout this whole time, then you’ll be stronger on the way out.

Katherine Banwell:

Dr. Faiman, from what you’ve described, undergoing CAR T-cell therapy can be a very intense process. Why would someone consider this option over another myeloma treatment option?

Dr. Beth Faiman:

Yeah. So, the CAR T-cell therapies have really transformed myeloma, in my opinion.

When we first started using CAR T-cell therapies, there was a long wait list because people who had had three, five, seven, 10, 12 prior therapies, they had very few other options. So, we had ethically assigned scores to people as to who – we’d get one or two slots a month and then we’d have 80-some people on this list. And we’re thinking, “How do we allocate who’s going to get this therapy?” And it’s because you can have a nice, long remission off of all therapy.

It’s a great, great option for most people. Again, I would hope that we can get this moved further into the disease trajectory. There are actually two studies. One was a KarMMa study. It was published in the New England Journal of Medicine in 2023, early part of 2023.

And it showed that when people get this therapy earlier, the Ide-cel first, you can have a longer remission. So, we’re talking about three, four, five or more prior lines of therapy you can get about 11 months with the Ide-cel.

You could even get a longer remission off of all therapy if you move it earlier. Same with Cilta-cel. We had studies and different cohorts and you can be in a long remission. So, think of somebody who’s – myeloma’s incurable. It’s very treatable but it’s incurable for most. And so, you go from the expectation of staying on treatment until disease progression, much like other chronic conditions like diabetes. We don’t stop medicine for diabetes or high blood pressure.

And it’s the same with myeloma and many of the cancers that we treat these days. And so, a CAR T-cell therapy will give patients the option of having that disease free interval where you can go and travel the world. I have patients that have bought RVs after their CAR T-cell therapy and now they’re going around the world – well, not the world. But around the United States.

Katherine Banwell:

The country.

Dr. Beth Faiman:

The country. And just really enjoying life and taking that time off and being realistic, knowing that we have to do bloodwork every month to make sure the myeloma’s still in remission because it can come back. But at least it’s sleeping for right now. So, you can go out and enjoy your life and take those trips and enjoy the little things and the big things.

Katherine Banwell:

Yeah. Well, thank you for that advice. I’d like to get to a few audience questions that were sent in prior to the program. Alice asks, can you share more information about T-cell collection? A recent webinar mentioned that myeloma must be in good control. Can you share specifics about the bridging therapy prior to infusion?

Dr. Beth Faiman:

Yes. So, again, the process is the lengthy process as we mentioned before. But for the actual T-cell collection, we will have approved you to get the therapy. Financially, we’ve cleared you. Socially, you’ve gotten your support systems and now we’re getting those cells out.

We use a process called apheresis where a temporary catheter is placed under the skin, and it separates your white blood cells and then returns the red bloods and plasma back into the blood. And it sorts out those T cells. The process itself, you’re on the machine for anywhere for two or three hours. Hopefully, it’ll just be one day’s time. And then, they’ll manufacture those cells.

So, during that period where we’ve put your cells and sent them away to wherever’s going to be doing the manufacturing, you’re going to need to get a treatment that’s going to keep you in remission from the myeloma. And it’s not going to prevent you from getting those cells safely back. So, we don’t want anything that’s too toxic for most people. So, what we’re doing now is we have that information that early on is better for myeloma to get these treatments. And so, the hope that bridging therapy won’t be as common of a thing anymore.

Because now we’re selecting people that are – the myeloma’s just starting to act up. Let’s get those cells out, send them off, so we don’t have to do bridging therapy. We can just keep you – add a medication or take away another medication to keep you in remission. So, that’s the goal of bridging therapy. What’s that bridge to get your cells back in for some people? It might be a chemotherapy type of a thing. But for other people it’s just trying to get you that CAR T-cell collection and manufacturing so we don’t really have to change everything all up.

And we’ve been very fortunate now that the wait lists have cleared in most institutions. CAR-T cell is available at more centers across the country and so we don’t have that backlog. And so, fortunately, bridging therapy will hopefully be a little bit less of a thing.

Katherine Banwell:

We have another question. This one from Rita. What kind of monitoring takes places in the months following CAR T-cell therapy and what kinds of medicines are required afterward?

Dr. Beth Faiman:

Oh, excellent. So, the monitoring is usually on the short-term, within the first 30 to 60 days afterwards, oftentimes depending on what your blood counts are showing. You might have to get blood counts tested more frequently. So, that complete blood count shows you the white cells, the red cells. The white cells fight infection. Red cells carry oxygen. Platelets clot the blood. That’s a marker of how well your bone marrow is functioning. It also can be – those innocent bystanders can go low temporarily after this procedure.

So, definitely those CBCs need to be tested, for some people weekly and for some people every other week. And your healthcare team will tell you how often. After that first two to three months and your blood counts are all in good shape, then we can just go oftentimes to a monthly monitoring of the myeloma labs. So, that’s the CBC and the chemistry panel but also the paraproteins in the blood and the urine get monitored.

There’s also another test called a CD4 count that’s something that you wouldn’t have had beforehand. The CD4 count is an immune count that we want to be over 200. Oftentimes, you’ll be on an antibiotic called Bactrim or an inhaled called pentamidine to lessen the chance of a certain kind of infection called PJP, or pneumocystis. So, those are those atypical infections that we’re now seeing with CAR-T cell and other therapies.

And as I mentioned, acyclovir to protect against shingles is a medication but you’re not going to be on any anti-myeloma medications other than maybe a bone strengthener if you get that intermittently. Fortunately, after CAR-T cell, you don’t have any anti myeloma therapy as long as you’re in remission.

Katherine Banwell:

We also received this question from a viewer named Rob. If you receive CAR-T therapy, how long does it last and have you seen remission for a long time?

Dr. Beth Faiman:

So, I’d like to tell Rob that I’ve seen a little bit of a remission and I’ve seen long-time remissions. Unfortunately, it goes back to the biology of the disease. People that have a more aggressive type of myeloma tend to not have as long of a remission but that’s not always the case. So, if you have what’s called a standard type of myeloma, which fortunately about 80 percent of the people have a standard or good type of myeloma, you can get an 11- to 24-month remission if you’ve had many prior therapies.

Now, if we’re moving the CAR-T earlier lines of therapy, as in those two studies that I briefly mentioned with the Ide-cel and the Cilta-cel studies that are moving it to one to three prior lines of therapy, people are getting longer remissions.

Unfortunately, I do not have a crystal ball. I can look at your disease genetics. I can look at how deep your remission status is and I can generally predict based on other studies how long of a remission you might get, but it’s not a guarantee. What works for one person might not work for the other so you take it with a grain of salt. We just say, “Gosh, this is a great therapy. We need to offer it to you while we have that window of opportunity. You’re in a good remission. We have a slot for you. We’re going to pick the best product for you. Let’s give you this option.”

You might be one of those exceptional responders that are in remission for several years, which I do have people that have been in remission several years, fortunately.

Katherine Banwell:

Okay. Well, thank you so much for the thoughtful responses to those questions. As we close out today’s program, can you talk about some of the ongoing research in CAR T-cell therapy and what you’re excited about?

Dr. Beth Faiman:

Oh, my gosh. I am so excited about CAR T-cell therapy research. There are these what we call CRISPR gene edited technology, which is really personalizing the treatment in CAR-T.

There’s what we call an off-the-shelf approach where we don’t have to manufacture one’s T cells to be a fighter. So, these CAR T-cell therapies are the kinds of clinical studies where if you are in a position where you want to hopefully get an earlier access to a great therapy, this CRISPR edited at – Caribou is what it’s called, that we have at my institution. That might be right for you.

There’s also the different targets. For example, the Ide-cel and the Cilta-cel target what’s called BCMA or B-cell maturation antigen. Basically, the BCMA is expressed mostly on cancer cells and less so on healthy cells.

And so, that’s what the target is for these current CAR-Ts. We have different targets. So, what does that mean for you? If you had a CAR T-cell therapy against BCMA or a bispecific against BCMA now we have these different targets so that gives you other options for remissions status. So, if you can, I am a big, strong advocate for clinical trials. Like I said, it’s getting better access. You have a healthcare team. There’s so much stigma associated with clinical trials, but every single person is a candidate for some sort of a trial or another.

So, talk to your healthcare team or you can go to clinicaltrials.gov and then all the patient care organizations – International Myeloma Foundation, Multiple Myeloma Research Foundation, has access to clinical trial information as well for patients. So, yes, lots of good things. New targets. Off-the-shelf so you don’t have to manufacture. So, that represents new treatment options for many patients.

Katherine Banwell:

Dr. Faiman, thank you so much for taking the time to join us today.

Dr. Beth Faiman:

My pleasure. Thank you for having me.

Katherine Banwell:

And thank you to all of our collaborators. To learn more about myeloma and to access tools to help you become a more proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for being with us.

CAR T-Cell Therapy | Care and Monitoring Post-Treatment

March 19, 2024/in MM Newly Diagnosed, MM Programs, MM Thrive CAR T, MM Thrive CAR T Support, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

CAR T-Cell Therapy | Care and Monitoring Post-Treatment from Patient Empowerment Network on Vimeo.

How are myeloma patients monitored after CAR T-cell therapy? Myeloma expert and researcher Dr. Beth Faiman explains the testing that takes place following CAR T-cell therapy, how long monitoring will occur, and medications that are commonly prescribed for post-CAR T-cell therapy care.

Dr. Beth Faiman is an Adult Nurse Practitioner in the department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic. Learn more about Dr. Faiman.

See More From Thrive CAR T-Cell Therapy

Related Resources:

Recovering From CAR T-Cell Therapy | What Can Myeloma Patients Expect?

CAR T-Cell Therapy for Myeloma | What Are the Advantages?

What Side Effects Are Possible Following CAR T-Cell Therapy?

Transcript:

Katherine Banwell:

What kind of monitoring takes places in the months following CAR T-cell therapy, and what kinds of medicines are required afterward?

Dr. Beth Faiman:

Oh, excellent. So, the monitoring is usually on the short-term, within the first 30 to 60 days afterwards, oftentimes depending on what your blood counts are showing. You might have to get blood counts tested more frequently. So, that complete blood count shows you the white cells, the red cells. The white cells fight infection. Red cells carry oxygen. Platelets clot the blood. That’s a marker of how well your bone marrow is functioning. It also can be – those innocent bystanders can go low temporarily after this procedure.

So, definitely those CBCs need to be tested, for some people weekly and for some people every other week. And your healthcare team will tell you how often. After that first two to three months and your blood counts are all in good shape, then we can just go oftentimes to a monthly monitoring of the myeloma labs. So, that’s the CBC and the chemistry panel but also the paraproteins in the blood and the urine get monitored.

There’s also another test called a CD4 count that’s something that you wouldn’t have had beforehand. The CD4 count is an immune count that we want to be over 200. Oftentimes, you’ll be on an antibiotic called Bactrim or an inhaled called pentamidine to lessen the chance of a certain kind of infection called PJP, or pneumocystis. So, those are those atypical infections that we’re now seeing with CAR-T cell and other therapies.

And as I mentioned, acyclovir (Zovirax) to protect against shingles is a medication but you’re not going to be on any anti-myeloma medications other than maybe a bone strengthener if you get that intermittently. Fortunately, after CAR-T cell, you don’t have any anti-myeloma therapy as long as you’re in remission.

CAR T-Cell Therapy for Myeloma | What Are the Advantages?

March 19, 2024/in MM Newly Diagnosed, MM Programs, MM Thrive CAR T, MM Thrive CAR T Understanding, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

CAR T-Cell Therapy for Myeloma | What Are the Advantages? from Patient Empowerment Network on Vimeo.

How has CAR T-cell therapy transformed care for myeloma patients? Myeloma expert and researcher Dr. Beth Faiman shares results from the KarMMa study that compared CAR T-cell therapy versus a standard regimen, and the benefits of this therapy over time.

Dr. Beth Faiman is an Adult Nurse Practitioner in the department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic. Learn more about Dr. Faiman.

See More From Thrive CAR T-Cell Therapy

Related Resources:

Advice for Myeloma Patients Undergoing CAR T-Cell Therapy

Is CAR T-Cell Therapy Right for You? Questions to Ask Your Myeloma Care Team

Recovering From CAR T-Cell Therapy | What Can Myeloma Patients Expect?

Transcript:

Katherine Banwell:

Dr. Faiman, from what you’ve described, undergoing CAR T-cell therapy can be a very intense process. Why would someone consider this option over another myeloma treatment option?

Dr. Beth Faiman:

Yeah. So, the CAR T-cell therapies have really transformed myeloma, in my opinion.

When we first started using CAR T-cell therapies, there was a long wait list because people who had had three, five, seven, 10, 12 prior therapies, they had very few other options.

So, we had ethically assigned scores to people as to who – we’d get one or two slots a month and then we’d have 80-some people on this list. And we’re thinking, “How do we allocate who’s going to get this therapy?” And it’s because you can have a nice, long remission off of all therapy.

It’s a great, great option for most people. Again, I would hope that we can get this moved further into the disease trajectory. There are actually two studies. One was a KarMMa study. It was published in the New England Journal of Medicine in 2023, early part of 2023.

And it showed that when people get this therapy earlier, the Ide-cel first, you can have a longer remission. So, we’re talking about three, four, five or more prior lines of therapy you can get about 11 months with the Ide-cel.

You could even get a longer remission off of all therapy if you move it earlier. Same with Cilta-cel. We had studies and different cohorts and you can be in a long remission. So, think of somebody who’s – myeloma’s incurable. It’s very treatable but it’s incurable for most. And so, you go from the expectation of staying on treatment until disease progression, much like other chronic conditions like diabetes. We don’t stop medicine for diabetes or high blood pressure.

And it’s the same with myeloma and many of the cancers that we treat these days. And so, a CAR T-cell therapy will give patients the option of having that disease free interval where you can go and travel the world. I have patients that have bought RVs after their CAR T-cell therapy and now they’re going around the world – well, not the world. But around the United States.

Katherine Banwell:

The country.

Dr. Beth Faiman:

The country. And just really enjoying life and taking that time off and being realistic, knowing that we have to do bloodwork every month to make sure the myeloma’s still in remission because it can come back. But at least it’s sleeping for right now. So, you can go out and enjoy your life and take those trips and enjoy the little things and the big things.

Recovering From CAR T-Cell Therapy | What Can Myeloma Patients Expect?

March 19, 2024/in MM Newly Diagnosed, MM Programs, MM Thrive CAR T, MM Thrive CAR T Understanding, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

Recovering From CAR T-Cell Therapy | What Can Myeloma Patients Expect? from Patient Empowerment Network on Vimeo.

What can myeloma patients expect after undergoing CAR T-cell therapy? Myeloma expert and researcher Dr. Beth Faiman discusses returning to life after the CAR T process, advice for physical activity, and immune system concerns during recovery.

Dr. Beth Faiman is an Adult Nurse Practitioner in the department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic. Learn more about Dr. Faiman.

See More From Thrive CAR T-Cell Therapy

Related Resources:

Advice for Myeloma Patients Undergoing CAR T-Cell Therapy

What Side Effects Are Possible Following CAR T-Cell Therapy?

CAR T-Cell Therapy | Care and Monitoring Post-Treatment

Transcript:

Katherine Banwell:

Beyond monitoring of any issues, what can someone expect related to returning to life as they knew it before the diagnosis? Is there a timeline for resuming lifestyle and activity?

Dr. Beth Faiman:

Yeah. So, I should say I because it’s from my perspective. I am a real strong advocate. I tell people to do what you feel like you can physically do. We know that myeloma can affect the bones and put your bones at risk for breaking and so we give you medicines to protect it. So, I do put some restrictions however on physical activity in terms of, “I don’t want you to bench press 40 pounds or 20 pounds,” in most cases. And depending on what the bones look like on x-ray, I’ll even restrict it to about five to 10 pounds.

If you think about it, that’s a bag of potatoes. So, you don’t want to put too many restrictions on for everybody. But talk to your healthcare provider about what your specific restrictions are with physical activity. Because I don’t really put any restrictions on but I encourage things like riding a bike, especially a stationary bike in your own home, so that if you fall off – hopefully, you won’t fall off a stationary bike. But if you injure yourself, then you’re able to be in a place that somebody can help you.

But riding a bike. Also, exercising in water. Water therapy is a great weight bearing exercise and there are times of day where you can go when the YMCAs or YWCAs aren’t as busy – or community centers. So, you’re less at risk for bacterial or other illnesses. But during that first month, I try to limit their exposure to people because you’re at risk for the different viruses that are all over the place, the bacterial infections.

So, that first month is the critical period where I try to say, “Okay, try to lay low. Let’s get you through this period. Your immune system will start getting stronger on its own after this period.” And then, that month two you start feeling like doing more. You go to the grocery store. You maybe go to eat out at a restaurant but pick a time of day that’s less busy. So, go for an early dinner. There’s no shame in eating at 5:00 p.m. if you want to go out. And then, get a table in the corner with your own wipes. And so, that’s where your immune system is getting stronger.

And then, by month three, I think most people will feel much, much better and much, much stronger. And if you can keep moving throughout this whole time, then you’ll be stronger on the way out.

CAR T-Cell Therapy | Key Considerations for Myeloma Patients

March 19, 2024/in MM Newly Diagnosed, MM Programs, MM Thrive CAR T, MM Thrive CAR T Preparing, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

CAR T-Cell Therapy | Key Considerations for Myeloma Patients from Patient Empowerment Network on Vimeo.

Myeloma expert and researcher Dr. Beth Faiman shares key considerations when planning for CAR T-cell therapy. Dr. Faiman reviews which patients qualify for CAR T-cell therapy, key aspects for patients to consider, and resources for clinical trials and CAR T-cell therapy information.

Dr. Beth Faiman is an Adult Nurse Practitioner in the department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic. Learn more about Dr. Faiman.

See More From Thrive CAR T-Cell Therapy

Download Resource Guide

Related Resources:

Planning for CAR T-Cell Therapy | Advice for Myeloma Patients

Considering CAR T-Cell Therapy? Key Advice From an Expert

What Side Effects Are Possible Following CAR T-Cell Therapy?

Transcript:

Katherine Banwell:

I’m sure many of our viewers today are wondering who the therapy is right for, and when is it most appropriate in the course of myeloma? Could you address that?

Dr. Beth Faiman:

Yeah, absolutely. So, currently, you have to have had three prior lines of therapy with drugs such as a CD38, which is – daratumumab (Darzalex) is a name of a medication.

You have to have a drug such as lenalidomide (Revlimid) as well as a drug like bortezomib (Velcade). And you have to have had three lines of therapy. So, that’s how you can access the therapy. But if you’re willing to participate in a well-designed clinical trial there are studies with CAR T-cell therapy earlier on.

So, one of the things that we’re advocating in the myeloma world is clinical trials. We haven’t gotten to where we are in 2024 with the advances in sciences, the advances in living longer and living well with myeloma, without the brave people before us that have participated in clinical trials.

So, people who it’s right for would be if they qualify for a clinical trial before their third or fourth line of therapy or if they’ve had three or four prior lines of therapy.

And there are other points to that which I’m sure we’ll talk about later on.

Katherine Banwell:

In your opinion, what are three key considerations that myeloma patients and care partners should think about related to the CAR T-cell therapy approach?

Dr. Beth Faiman:

Well, I would like to say that always when you’re selecting a therapy, think of the physical, the financial, and the social implications of that therapy. So, physically is the medication too strong for you? Are you too weak to take it? Or is it just right for you? So, finding the right medication for the right patient at the right dose at the right time. So, the physical component.

The financial component is also very important. So, maybe your insurance now won’t cover it but then there’s open enrollment in Medicare towards the end of the year or you can find financial support reimbursement through many of our generous organizations that will provide grants for certain medications.

And then, the social. Do you have a care partner, as we discussed? The importance of being monitored for 30 days. If you don’t have a formal care partner, is there some system that we can help support you through so that you can have the different supports throughout. It’s not only that beginning part where you’re gaining the information – and I think of it like a timeline. The beginning part, you’re thinking about gathering information to the – in that process of getting yourselves back because of the side effects, which I think have been talked about in a prior webinar.

And then, the post-monitoring where you go back to your community, taking antibiotics, antiviral medications, etc., to keep you living well longer. So, it’s a process.

Katherine Banwell:

Well, it’s great advice, Dr. Faiman, thank you. I’d also like to add that if you’re considering CAR T-cell therapy, the Patient Empowerment Network has a wealth of information on this topic, including resource guides and interviews with experts like Dr. Faiman. And you can find those at powerfulpatients.org/myeloma.

What Side Effects Are Possible Following CAR T-Cell Therapy?

March 19, 2024/in MM Newly Diagnosed, MM Programs, MM Thrive CAR T, MM Thrive CAR T Understanding, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

What Side Effects Are Possible Following CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.

Myeloma expert and researcher Dr. Beth Faiman shares an overview of both rare and mild side effects that may affect people who have undergone CAR T-cell therapy. Dr. Faiman also discusses patient monitoring and explains methods to help combat potential issues caused by CAR T-cell therapy.

Dr. Beth Faiman is an Adult Nurse Practitioner in the department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic. Learn more about Dr. Faiman.

See More From Thrive CAR T-Cell Therapy

Related Resources:

Advice for Myeloma Patients Undergoing CAR T-Cell Therapy

What You Need to Know About Accessing CAR T-Cell Therapy

Considering CAR T-Cell Therapy? Key Advice From an Expert

Transcript:

Katherine Banwell:

So, after CAR T-cell therapy is completed, what potential side effects might people experience, and what should they look for?

Dr. Beth Faiman:

Absolutely. I think of things in short-term and long-term side effects. So, the short term, you’re going to be admitted to the hospital and you have a risk for – when we get those T cells back – that cytokine release syndrome, or it’s abbreviated CRS – where you’re body’s immune system’s fighting.

I tell folks it’s kind of like if you got a vaccine for a flu vaccine or pneumonia and you had a reaction it’s just way worse. So, you can get a high fever – the big first sign of this CRS. Usually, the providers will jump in with giving you a medication called tocilizumab (Actemra) or a similar drug that blocks IL-6, which is a chemical that is triggered when we get the CRS. And then, it stops those symptoms. And so, most of us know how to do that and will approve your insurance to get access to that tocilizumab or similar drug when we approve your CAR T-cell therapy.

So, that CRS can get you really, really sick. You can get low oxygen levels in your blood. You can get a high fever and you can drop your blood pressure. But most CAR T-cells centers, the nurses and the staff are very well-trained to monitor this every eight hours, in most cases.

Another rare side effect we worry about is ICANS, and it’s a neurotoxicity kind of thing.

It can be with CRS or without CRS. But they’ll ask you to do things like write your name on a piece of paper every eight hours or tell me – draw a clock or count backwards from 100. And so, if you have any deviation, even minor, from what you reported back beforehand then we worry about neurotoxicity. Now, that’s short term but that’s the reason why you can’t drive a car for 30 days is because it could be delayed.

The CRS can start with the one thing, the Ide-cel usually occurs within one day so most people are admitted to the hospital for that CAR T-cell therapy. The Cilta-cel, it onsets to about seven days. So, some people get the Cilta-cel outpatient and then are monitored daily, whether in person or through virtual telehealth monitoring.

But at any rate, those are the short-term. Long-term, we worry about low blood counts maybe for the first month afterwards. And then, those will come back to normal. And then, we worry about infection. So, I mentioned the antibacterial, antiviral, which is usually a medicine called acyclovir (Zovirax), which most myeloma patients will have been on anyhow. And then, that IVIG to protect against viruses and bacteria when your immune system is so low.

But fortunately, if we control the CRS, it usually comes with the CRS, although it can be independent. We try not to give steroids, because we don’t want it to interrupt the CAR T-cell process. But many institutions will give that tocilizumab for ICANS. And if that doesn’t get better then they’ll give you a steroid, such as dexamethasone (Decadron).

And so, that will usually reverse itself pretty quickly. Longer term, after 30 days, you can get with the Carvykti, particularly something called Parkinsonian things where you can get a little bit shaky or something like that. Again, it’s very rare and I have had hundreds of people who have undergone the CAR T-cell procedure at my institution. And knock on wood, fortunately, I’ve not seen first-hand that side effect. And I think it’s because we’re so good now at treating the – preventing the ICANS and CRS as best as we can while they’re inpatient and doing real close following.

One other thing I want to note is if somebody who’s watching this does go in the hospital for any reason, get up and walk around and stay strong, as well as you can, during the procedure. You might be bored if you’re in the hospital anyhow, but try to stay as strong as you can in the hospital. It’ll help your post recovery for sure.

Katherine Banwell:

Well, what about more mild side effects like fatigue and changes in appetite?

Dr. Beth Faiman:

Absolutely. So, the fatigue and the changes in appetite are generally mild for most but I see it, in my experience, if your myeloma’s acting up really quickly, if you’re having a rapid disease progression, the medications that we give you to control the myeloma during this bridging therapy phase might cause some of that as well, not necessarily the CAR T-cell process. But think about it. We’re using your own cells engineered to be fighters.

And so, that first month or two is probably when you’re going to be the most tired as your body is being programmed to fight against the myeloma cells. That fatigue tends to get better. And as I mentioned just a moment earlier, the importance of just walking around in the halls, getting out of bed when you’re in the hospital, that can really help your post recovery. It doesn’t seem like much, but there have been many studies about how muscle mass declines, energy declines when you’re hospitalized.

And we want you to be as strong as you can and thrive as much as you can for when you’re out you can then do the things you want to do at a quicker pace.

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