Tag Archive for: bispecific antibodies

Advice for Setting Myeloma Treatment Goals and Collaborating on Care Decisions

Advice for Setting Myeloma Treatment Goals and Collaborating on Care Decisions from Patient Empowerment Network on Vimeo.

This animated video defines common myeloma treatment goals, provides an overview of available myeloma therapies, and includes advice for making care decisions and the importance of being your own advocate.

See More from Collaborate Myeloma

Related Resources:

Collaborate | Being an Empowered Myeloma Patient

Understanding Myeloma | How You Can Collaborate in Your Care

Understanding Myeloma | How You Can Collaborate in Your Care

The Benefits of Shared Decision-Making for Myeloma Care


Transcript:

Bianca: 

Hi! I’m Bianca, a nurse specializing in myeloma. In this video, we’ll discuss myeloma therapy and explain how to work with your healthcare team so that you can choose a care plan best suited for YOUR myeloma. 

I’d also like to introduce you to Suzanne. Suzanne is a patient advocate living with myeloma.  

Suzanne: 

Thanks, Bianca. I’m happy to share my own experience and to talk about how I worked with my healthcare team to decide on a care plan. 

When my doctor and I were first considering my options, we started by setting treatment goals. Bianca, can you define treatment goals?  

Bianca: 

Sure! Each patient is unique, so it may vary by person. You should collaborate WITH your healthcare team to determine YOUR treatment goals. Common goals of myeloma treatment may include: 

  • Reducing and managing your symptoms. 
  • Slowing the progression of the disease. 
  • Inducing remission. 
  • And, helping you live longer while maintaining quality of life.

Suzanne: 

Thanks for explaining this. When I discussed treatment goals with my doctor, I pointed out that I still wanted to be able to play pickleball with my friends, and to care for my young grandchildren. We reviewed options that could allow me to stay as active as possible and manage my myeloma at the same time. 

Bianca: 

That’s a great point, Suzanne. It’s also important to remember that your treatment goals can change throughout the course of your myeloma. Discuss them regularly, not just with your care team but also your care partner – that can be a family member or even a close friend. 

Suzanne: 

That’s right. I discussed my care with my husband AND my adult children – it’s important to keep your support team in the loop.  

And it’s also essential to understand the treatment options available to you. Bianca, what are the types of therapy available to treat myeloma? 

Bianca: 

There are a number of different classes of therapy, which include: 

  • Proteasome inhibitors; 
  • Immunomodulatory therapies or IMiDs; 
  • Monoclonal antibodies; 
  • Stem cell transplants; 
  • There are also the new and recently approved therapies such as bispecific antibodies and CAR (Chimeric Antigen Receptor) T-cell therapy; 
  • And, of course, clinical trials.   

Clinical trials can be a good option for patients at any stage of disease, often giving patients early access to a viable and cutting-edge therapy. When considering treatment, you should ask your doctor if there is a clinical trial that may be right for you.  

Suzanne: 

Good point! When I was deciding on a therapy, my doctor and I, along with my husband, discussed the risks and benefits of each approach as well as the potential outcome of each option. My doctor also walked through the clinical trials that were available to me. 

Bianca, given all of the options, how do you decide which therapy is appropriate for a particular patient? 

Bianca: 

That’s a great question. As mentioned in our previous video, results of in-depth testing, which determine if a patient has low-risk or high-risk myeloma, can affect your choices. Other factors that impact treatment decisions may include: 

  • Your age, overall health, and any pre-existing conditions. 
  • Potential side effects of the treatment. 
  • Previous therapies that may have been used to treat your myeloma. 
  • The financial impact of a treatment plan. 
  • And the patient’s lifestyle and preference.  

Suzanne: 

That’s right. And, you shouldn’t hesitate to weigh in on what YOUR preference is. Do your own research so you understand each treatment approach, then work WITH your healthcare team to determine what might be best for you.  

Bianca: 

That’s excellent advice, Suzanne. So, when making treatment decisions, you should: 

  • Work with your healthcare team to understand your treatment goals. 
  • Talk with your doctor about all available treatment options. 
  • And, inquire about any clinical trials that may be right for you. 
  • Then, discuss the pros and cons of each option. 
  • Bring a care partner with you to appointments and take time post-visit to discuss the proposed plan and treatment options. 
  • And, always remember that you have a voice in your care. Speak up and ask questions. You are your own best advocate. 

Suzanne: 

Great advice, Bianca. Don’t forget to visit powerfulpatients.org/myeloma to learn more. Thank you for joining us!  

How Can Bispecific Antibody Therapy Care Partners Be Proactive?

How Can Bispecific Antibody Therapy Care Partners Be Proactive? from Patient Empowerment Network on Vimeo.

What are some ways for myeloma bispecific antibody therapy care partners to be proactive? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute shares lifestyle modifications, reasons to speak up and ask questions, and advice for care partners to take proactive steps for both the patient care and self-care during bispecific antibody therapy. 

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

Bispecific Antibody Therapy | Managing Side Effects

Bispecific Antibody Therapy | Managing Side Effects

Transcript:

Katherine:

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 bur ner. 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 because 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 have 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, during treatment, are there any lifestyle changes that need to be made? Like diet, for instance?  

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. 

Bispecific Antibody Therapy Support | Care Team Members and Resources

Bispecific Antibody Therapy Support | Care Team Members and Resources from Patient Empowerment Network on Vimeo.

What should myeloma patients know about bispecific antibody therapy support? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute discusses care team members and support resources for bispecific antibody therapy patients and care partners. 

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

How Can Bispecific Antibody Therapy Care Partners Be Proactive?

How Can Bispecific Antibody Therapy Care Partners Be Proactive?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

Bispecific Antibody Therapy | Managing Side Effects

Bispecific Antibody Therapy | Managing Side Effects

Transcript:

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. 

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

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

How can a myeloma care partner support a bispecific antibody therapy patient? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute explains ways that care partners can offer logistical and emotional support and shares tips for staying well-informed and organized during the treatment journey.

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

How Can Bispecific Antibody Therapy Care Partners Be Proactive?

How Can Bispecific Antibody Therapy Care Partners Be Proactive?

How Has Bispecific Antibody Therapy Impacted Myeloma Care?

How Has Bispecific Antibody Therapy Impacted Myeloma Care?

Bispecific Antibody Therapy Support | Care Team Members and Resources

Bispecific Antibody Therapy Support | Care Team Members and Resources

Transcript:

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. 

Bispecific Antibody Therapy | What Is the Treatment Duration and Response?

Bispecific Antibody Therapy | What Is the Treatment Duration and Response? from Patient Empowerment Network on Vimeo.

What can myeloma bispecific antibody therapy patients expect for treatment duration and response? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute discusses treatment factors that may impact response, common monitoring tests during treatment, and what might be considered an ideal therapy response.

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

How Can Bispecific Antibody Therapy Care Partners Be Proactive?

How Can Bispecific Antibody Therapy Care Partners Be Proactive?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

Bispecific Antibody Therapy Support | Care Team Members and Resources

Bispecific Antibody Therapy Support | Care Team Members and Resources

Transcript:

Katherine:

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 their 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. 

Bispecific Antibody Therapy | Managing Side Effects

Bispecific Antibody Therapy | Managing Side Effects from Patient Empowerment Network on Vimeo.

What should myeloma bispecific antibody therapy patients know about managing side effects? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute discusses common short-term and long-term side effects, members of the healthcare team, medications for managing side effects, and how care partners can support bispecific antibody patients.

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

Bispecific Antibody Therapy Support | Care Team Members and Resources

Bispecific Antibody Therapy Support | Care Team Members and Resources

Transcript:

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. 

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 (Talvey), 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. 

How Is Bispecific Antibody Therapy Administered?

How Is Bispecific Antibody Therapy Administered? from Patient Empowerment Network on Vimeo.

How is myeloma bispecific antibody therapy given to patients? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute explains how the treatment is administered in the body, hospital types to access the treatment, and what patients should expect for the procedure and monitoring.

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

What Is the Role of a Care Partner in Bispecific Antibody Therapy?

Bispecific Antibody Therapy | Managing Side Effects

Bispecific Antibody Therapy | Managing Side Effects

Transcript:

Katherine:

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. 

Bispecific Antibodies for Myeloma | Patient Eligibility Requirements

Bispecific Antibodies for Myeloma | Patient Eligibility Requirements from Patient Empowerment Network on Vimeo.

What are the myeloma patient eligibility requirements for bispecific antibodies? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute discusses patient types that work well with bispecific antibody therapy, patient eligibility requirements, and updates about research developments with bispecifics.

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

Bispecific Antibody Therapy | What is the Treatment Duration and Response?

How Is Bispecific Antibody Therapy Administered?

How Is Bispecific Antibody Therapy Administered?

Bispecific Antibody Therapy | Managing Side Effects

Bispecific Antibody Therapy | Managing Side Effects

Transcript:

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 kind of 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. 

How Has Bispecific Antibody Therapy Impacted Myeloma Care?

How Has Bispecific Antibody Therapy Impacted Myeloma Care? from Patient Empowerment Network on Vimeo.

What has been the impact of bispecific antibody therapy for myeloma care? Nurse practitioner Alexandra Distaso from Dana-Farber Cancer Institute discusses how bispecific antibody therapy fights cancer and patient situations that are served especially well by the therapy.

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

See More from The Care Partner Toolkit: Bispecific Antibodies

Related Resources:

Bispecific Antibodies for Myeloma | Patient Eligibility Requirements

Bispecific Antibodies for Myeloma | Patient Eligibility Requirements

How Is Bispecific Antibody Therapy Administered?

How Is Bispecific Antibody Therapy Administered?

Bispecific Antibody Therapy | Managing Side Effects

Bispecific Antibody Therapy | Managing Side Effects

Transcript:

Katherine:

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. 

Understanding Myeloma Therapy Targets BCMA and GPRC5D

Understanding Myeloma Therapy Targets BCMA and GPRC5D from Patient Empowerment Network on Vimeo.

What are myeloma targets, and how do they impact the effectiveness of therapy? Dr. Krina Patel explains how treatments like bispecific antibodies and CAR T-cell therapy are using myeloma targets such as BCMA (B-cell maturation antigen) and GPRC5D (G protein-coupled receptor 5D) to kill myeloma cells. 

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma.

Related Resources:

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

Transcript:

Katherine:

We know that the currently approved bispecific antibody therapies target BCMA and GPRC5D. What are these targets precisely and how do they impact the effectiveness of the treatment? 

Dr. Krina Patel:

No, it’s a great question.  

And, again, so BCMA we’ve had for a little bit longer.  

We’ve known about it for a little bit longer, B cell maturation antigen, which definitely we’ve used as much as we can. So, we’ve had CAR Ts for it. We’ve had bispecifics for it. We’ve had antibody drug conjugates that we’ve attached to it. 

So, it’s a really good target that is mostly just on myeloma cells and on very few other cells in the body, for the most part, which is why it makes such a great target. The side effects really should happen only specifically against the myeloma; so, less side effects in terms of toxicity. That’s not 100 percent the case.  

BCMA is in some other tissues, like maybe the nerves, and that’s why maybe we see this toxicity sometimes, potentially in the GI system. Some patients can have it in other places. If you have myeloma in, let’s say, areas like the kidney. If you have a plasmacytoma, it can go to the kidney, things like that.  

But again, for the most part, mostly on myeloma. And what’s really important about these targets is, once you get a treatment for it, what happens to that target. So, that’s a little bit different between these two targets. So, BCMA is a part of the proliferation of myeloma cells. So, it actually helps the myeloma cell survive. And so, the myeloma cells really want that BCMA on there. Now, for CAR T, for the most part, we don’t see people losing BCMA. We might see it go down in the myeloma cells that are left. For some patients, the expression can go down. But for the most part, we’ll see it come back up a few months later if the myeloma’s coming back.  

The way that resistance happens with BCMA is that, when people are on bispecifics, the other treatment, we can sometimes see the BCMA get mutated. And then, maybe the other therapies we have won’t go after it any more.  

So, again, it’s not common, but that’s sorta something we look at when we talk about sequencing therapy or which therapy should we use first. Then, GPRC5D’s a little different.  

So, again, mostly just on myeloma cells. But here, we do know it’s on something called epithelial cells, which is skin, nails, tongue. And that’s why some of the side effects that we see, especially with the bispecific that’s a standard of care already, talquetamab, is skin and nail changes. So, people can get sloughing of their hands and nails; that can get disrupted. And then, taste. People can actually have some significant taste loss, to the point that they can have weight loss from it.  

So, this is why that part is so important that if we have patients with these side effects, we need to hold the drug or decrease it; so, make sure we can turn those around. And then, the way GPRC5D is we think that it’s a little bit more likely that you can lose it once you get a treatment with GPRC5D that the myeloma can actually learn how to shed the antigen.  

So, again, this really becomes important when we talk about combination and sequencing of all these different therapies we have and what’s the best way to do it so that patients can have the best response and the longest response.

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care? from Patient Empowerment Network on Vimeo.

What progress is being made in furthering advancing CAR T-cell therapy for myeloma? Dr. Krina Patel discusses the manufacturing process for CAR T-cells, research updates for manufacturing CAR T-cells faster, and the benefits of bridging therapy for some patients. 

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma.

Related Resources:

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment?

Advances in Managing CAR T-Cell Therapy Side Effects

Advances in Managing CAR T-Cell Therapy Side Effects

Transcript:

Katherine:

Are there other advances in CAR T-cell therapy that patients should know about?  

Dr. Krina Patel:

Yeah, so I think part of the issue right now is manufacturing and how long it takes for patients to get those cells. So, we use it to our advantage in the sense that earlier-line patients will have bridging therapy that we can give them while we’ve collected their cells and they’re being made; it takes are 4 to 6 weeks, or even eight weeks sometimes that we can give them a therapy that can knock their myeloma down before they get the CAR T.  

And again, this is really important that we have options available. So, in fifth-line we don’t have very many options available. So, a lot of my patients, we really are just struggling to keep the myeloma controlled, try to bring it down before they get their CAR T. We’re hoping that that CAR T comes in any day.  

When it goes earlier, I’m hopeful that now we’ll have options to actually bridge patients better because we’ll have more therapies they haven’t had. And the reason that bridging is so important is it really does decrease toxicity, some of the serious toxicity with see with CAR T; significantly decreases it.

And the efficacy. We see patients will do much better for longer if they have less myeloma going in than lot of myeloma going in. And so, again, I think because of that time, if we could get those cells earlier, that just makes it so much easier for all our patients to make sure that they’re able to get the cells. So, there’s quite a few different trials looking at fast CAR T production.  

And so, there’s the PH383, I think. I can’t remember the number exactly. But this is one of the studies that was happening at Dana-Farber, and Dr. Sperling has presented couple time. The cells are made within just 24, 48 hours. And then, they actually go in and as they’re killing the myeloma, they grow.  

So, they grow inside the body which is really, really, I think, a interesting way to develop CAR Ts for the future, make it more applicable and accessible. And then, there’s other companies in China. There’s the FasT CAR, which is a CD-19 plus BCMA, so two targets. But again, they can make their CAR Ts within a week.

And in the end, you have to still do quality checks for the FDA, which still take two weeks. So, it always will still be a few weeks, but still, the faster you can make those CAR’s, the more likely our patients are gonna be able to get it. And then, I think the combination studies. Again, there’s gonna be studies with different targets. So, there’s two CAR Ts, again, GPRC5D, that are going to be tested in the U.S.  

A phase two study. And then, also another phase one study. And then, the phase two study, that GPRC5D CAR T is going to have combination studies coming out very, very soon. Actually, it’s already open in some places, and more places that are opening soon.  

So, I think, yes, a lot’s going on again with new antigens and combinations. 

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment?

Will CAR T-Cell Therapy Be Approved for Earlier Lines of Myeloma Treatment? from Patient Empowerment Network on Vimeo.

Is there an opportunity for myeloma patients to gain access to CAR T-cell therapy sooner? Dr. Krina Patel discusses the results of clinical studies for CAR T-cell therapy and the potential for patients receiving the treatment earlier in their myeloma journey.

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma.

Related Resources:

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

How Is CAR T-Cell Therapy Research Advancing Myeloma Care?

Advances in Managing CAR T-Cell Therapy Side Effects

Advances in Managing CAR T-Cell Therapy Side Effects

Transcript:

Katherine:

Dr. Patel, current CAR T-cell therapy is FDA approved for patients who have had several lines of treatment. 

But we know that there are a number of trials that are exploring this treatment in earlier lines. So, what is the progress on these trials? 

Dr. Krina Patel:

Yeah. So, I think we have two major ones that have already been done and we’ve heard the results from. So, CARTITUDE-4 was for cilta-cel in second to fourth-line; so, patients who have relapsed once, all the way up to three times.  

And then, KarMMa-3, which is ide-cel, which was one line later. So, that was third-line to fifth-lines; so, relapsed twice to four times. So, little bit different patient populations in the two trials. The trials were different in that patients had different therapies before too.  

But both were positive studies which was what was really exciting. So, in CARTITUDE-4 patients were randomized, meaning they got either the CAR T or they got a standard of care option. And the CAR T won by a lot. This was, we call, hazard ratios.  

But basically, the amount of different of patients surviving when they got CAR T without myeloma versus the standard of care was one of the biggest differences we’ve ever seen in a clinical trial for multiple myeloma. So, it’s – 

Katherine:

Wow. 

Dr. Krina Patel:

– something really pretty amazing. And then, KarMMa-3, that trial, same thing. There’s a huge difference in the patients who got CAR T versus the standard of care. The standard of care options were different in the two trials for the most part. So, again, different patient populations and different standard of care options, but the other big thing that the KarMMa-3 study did was they allowed for patients who are on the standard of care that, once they were relapsing, they could get the CAR T.  

And so, because we have this crossover the big controversial thing that came up was, “Well, patients aren’t necessarily living longer by getting CAR T earlier. As long as they get CAR T they do really well.” And so, that is why there was a big meeting with the FDA what we call the ODAC meeting.  

So, they had both companies present their trials to the FDA and to this advisory board that they had called ODAC, and thankfully it was positive. So, both studies were positive in terms of the advisory board saying that they agreed these should be moved up forward.  

So, now we’re just waiting and hoping the FDA approves them so that we can actually give it to patients. I think the biggest reason is access. So, we know that when patients are fifth-line, which is when it’s approved now, not everybody makes it to fifth-line. It’s really hard to get through all these therapies and then still be healthy enough to do this versus if it’s approved in second and third-line, that just means so many people can actually get these therapies and available to them.  

And the other big thing is the quality-of-life piece for CAR T. It’s been such a big difference when patients get a break from therapy for a year or two years or longer compared to being on continuous therapy. And so, both studies have had quality of life studies come out as well showing that difference between the standard of care versus the CAR T.  

Myeloma Support and Resources | Why It’s Essential to Voice Your Concerns

Myeloma Support and Resources | Why It’s Essential to Voice Your Concerns from Patient Empowerment Network on Vimeo.

Why should you speak up when it comes to your myeloma care? Dr. Sikander Ailawadhi discusses the importance of sharing issues with your healthcare team in order to access support and resources that can help. 

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

Related Resources:

Accessing Quality Myeloma Care | Advice for Overcoming Obstacles

Accessing Quality Myeloma Care | Advice for Overcoming Obstacles

Key Advice for Myeloma Patients | Questions to Ask About a Care Plan

Myeloma Symptom Management | An Expert’s Approach

Myeloma Symptom Management | An Expert’s Approach

Transcript:

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.    

Available Myeloma Treatment Options for Patients | An Overview

Available Myeloma Treatment Options for Patients | An Overview from Patient Empowerment Network on Vimeo.

What are the current myeloma treatment approaches? Myeloma expert Dr. Sikander Ailawadhi shares an overview of treatment options, the necessity of combination therapy in myeloma, and the role of clinical trials in patient care. 

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

Related Resources:

Key Advice for Myeloma Patients | Questions to Ask About a Care Plan

The Benefits of Shared Decision-Making for Myeloma Care

The Benefits of Shared Decision-Making for Myeloma Care

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

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

Transcript:

Katherine:

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:

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.    

Advances in Managing CAR T-Cell Therapy Side Effects

Advances in Managing CAR T-Cell Therapy Side Effects from Patient Empowerment Network on Vimeo.

What progress is being made in treating the side effects of CAR T-cell therapy? Myeloma expert Dr. Krina Patel discusses the research and advances being made in understanding and managing the common issues associated with this treatment.

Dr. Krina Patel is an Associate Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, Texas. Dr. Patel is involved in research and cares for patients with multiple myeloma. 

See More From Thrive CAR T-Cell Therapy

Related Resources:

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

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

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

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

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

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

Transcript:

Katherine Banwell:

Dr. Patel, what about managing the side effects of CAR T? Is that improving?  

Dr. Krina Patel:

It is. I think just the fact that we are now seeing less of the neurotoxicity that we were seeing in the initial patients that were getting CAR T, and the serious neurotoxicity like the Parkinsonianism or patients couldn’t walk or hold things because of the tremors they were having that were so significant.  

And then something kinda like Guillain-Barré where people are getting ascending paralysis. And so, again, those are very serious things that we don’t want any of our patients to get. And again, most of it was with cilta-cel and their CARTITUDE-1 study. There is a black-box warning with ide-cel too that that can happen.  

We just don’t see it at the same rate. And again, when patients got better bridging going into CAR T, that rate dropped from 6% to 0.5%. So, it really is a huge difference by just giving better bridging and having myeloma controlled better going in.  

We are seeing some other side effects that we didn’t necessarily see on the original clinical trials, like facial palsies. These are things where patients can talk very well anymore or their side of their face is drooping. And those are reversible thankfully, for the most part with steroids, things like that. So, we watch for that. There’s some other side effects.

Again, these are immune cells going into your body, so anything can happen. So, we definitely keep a close eye on all of our patients. But for the most part, especially things like infections and this neurotoxicity, we’ve learned that again the less myeloma going in, the better patients do and the faster they recover.  

So, for the most part, patients now are doing much, much better than when patients were originally on those trials where we didn’t know what was gonna happen. And I think the infection piece is such a big deal; that our patients definitely need supportive care.  

So, even though this is a one-and-done where you get your chemo, you get your CAR T’s and then you’re not on any myeloma therapy, you are on supportive therapies; so, things like IVIG for your immune system, things to protect you against something called PJP pneumonia for at least six months if not longer.  

You’re still on anti-shingles medication. So, it’s not that you stop all medicines, but it’s you stop the myeloma medicines. And then, at least for the first six months, maybe even up to a year we have to make sure you don’t get any major infections.