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

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.

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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? Resource Guide

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

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.

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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.  

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

What Is the Role of Bispecific Antibody Therapy in the Future of Myeloma Care? from Patient Empowerment Network on Vimeo.

From the 2023 American Society of Hematology (ASH) annual meeting in San Diego, Dr. Peter Forsberg discusses how new data and learnings around bispecific antibodies may allow this newer myeloma therapy to be used more broadly in the clinical setting.

Dr. Peter Forsberg is associate professor of medicine at the University of Colorado School of Medicine and is a specialist in multiple myeloma. More about Dr. Forsberg.

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Transcript:

Dr. Peter Forsberg:

The role of bispecific antibodies is one that’s evolving quickly. We’ve had new therapies approved over the past 12 months. We may get more approvals in the future. And we’re certainly going to get increasing data around using those treatments in our clinics outside of the controlled clinical trial setting as well as maybe information around more diverse utilization in different treatment settings.   

So, I think these are going to be medicines that are used much more broadly in the future than they are now. Right now, they have a really impactful role in a certain group of patients.  

I think that’s going to become something that’s broader in the future. And I really do think there’s something that’s going to help us to improve on already a really good group of options in earlier relapsed settings and maybe even upfront treatment of myeloma in the future. 

So, a lot to be figured out, a lot of refinement in the future about how and when to use these treatments. But it’s very clear that they’re going to have a huge impact in different settings.  

Dr. Peter Forsberg | Myeloma Research News From the 2023 ASH Annual Meeting

Dr. Peter Forsberg | Myeloma Research News From the 2023 ASH Annual Meeting from Patient Empowerment Network on Vimeo.

Myeloma specialist Dr. Peter Forsberg reviews highlights from the 2023 American Society of Hematology (ASH) annual meeting. Dr. Forsberg shares what this promising news means for patients as well as advice for talking to your doctor about emerging therapies.

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Transcript:

Dr. Peter Forsberg:

My name is Peter Forsberg. I’m an associate professor at the University of Colorado. I am a specialist in multiple myeloma and other plasma cell disorders. And I’m here at ASH, where it’s always the most exciting time of the year for those of us in the hematology and hematologic/oncology community, where we are getting all the breaking information around all kinds of diseases.  

But a really exciting time in terms of new findings for myeloma and the other diseases we deal with.   

I think it covers a really broad spectrum. That’s been one of the really exciting things about myeloma over the past decade really is that we’ve had developments in so many different directions in terms of new therapies, new options for patients who need later line treatments, new options improving early line therapy.  

Certainly exciting to have a couple of very big studies that are being presented this year, two Phase III trials that look at four drug combinations in the newly diagnosed myeloma setting, which both show fantastic effectiveness. So, hopefully, really going to help expand that for patients with new myeloma to get really the best treatment out of the gate. And then, really maturing data around new immune therapies, both in the settings where they’re currently approved, which are sometimes later lines for myeloma patients. And then, more data on earlier lines for those therapies where they’re likely to be used in the very near future.   

At this meeting and over the past year, and ASH is always a big summation of a lot of the research that’s going on at any given time, the breakthroughs that are happening in myeloma, the innovation that’s happening in myeloma is very impactful for patients. It’s giving us great, improved options for earlier line patients allowing them to live better, live longer, preserving quality of life and then, giving us diverse new options in relapsed myeloma where we’ve had good tools but the broadening of that toolbox is very exciting.   

And it allows new and really effective options across all kinds of patient types. So, it’s really impactful across different settings.  

Patients shouldn’t hesitate to ask what are the new and developing treatment options, to ask their physicians are there new treatment options for myeloma that might be a fit for me now or in the future? Don’t hesitate to think about what might come down the road, even if you’re in a steady place with your myeloma because things are changing quickly.  

Our options now are different than they were six or 12 months ago and they’re going to be different six or 12 months from now.  

So, don’t hesitate to ask what’s new, what’s coming, should I meet with a myeloma specialist to discuss some of those specific options and whether they’re a fit for me. So, don’t hesitate to be the squeaky wheel a little bit and say what might be out there for me now or in the future.  

Expert Perspective | Understanding the Recent FDA CAR T-Cell Therapy Warning

Expert Perspective | Understanding the Recent FDA CAR T-Cell Therapy Warning from Patient Empowerment Network on Vimeo.

The Food and Drug Administration (FDA) announced in December 2023 that it is investigating reports of secondary cancers in some patients who have undergone CAR T-cell therapy, noting that “the overall benefits of these products continue to outweigh their potential risks for their approved uses.” Timothy Schmidt, a myeloma specialist, shares his perspective on the recent news.

Dr. Timothy Schmidt is an Assistant Professor in the Department of Medicine, Division of Hematology, Medical Oncology and Palliative Care at the University of Wisconsin School of Medicine and Public Health. More about Dr. Schmidt.

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Transcript:

Dr. Timothy Schmidt:

So, in terms of the FDA update about CAR T-cell therapies, there was a recent warning, essentially, about an increased risk for a specific type of lymphoma involving T cells. And we don’t really know a whole lot about this just yet. But what we do know is that these events are rare and that we need to investigate it further. I think as of right now, this is not a huge area of concern for most of us, myself included. 

When we have patients who are candidates for CAR T-cell therapy in multiple myeloma, generally, this means that patients are in need of a very effective treatment to get their disease under control and to do so for a long period of time. And the potential benefit of this therapy dramatically outweighs any of these kinds of long-term consequences or these newer things that are starting to develop. Now, I do think that this is something that we’re going to need to continue to keep an eye on. And we certainly can’t ignore this, especially as we start to move CAR T-cell therapy into earlier lines of therapy. 

But as of right now, I would not weigh this very heavily in my decision whether to do a CAR T-cell therapy for somebody with multiple myeloma.