ELEVATE | Myeloma CAR T-Cell Therapy: Options, Key Questions, and What to Expect

Transcript

Katherine Banwell: 

Hello, and welcome. I’m your host, Katherine Banwell. Today’s program is part of the Patient Empowerment Network’s Elevate series, which aims to help patients and care partners feel confident and well-informed when making decisions with their healthcare team. In today’s program, we’re going to hear from an expert to learn more about CAR T-cell therapy for myeloma. 

Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. 

Well, let’s meet our guest today. Joining us is Dr. Doris Hansen. Dr. Hansen, welcome. Would you please introduce yourself? 

Dr. Doris Hansen: 

Thank you so much for having me here today. So, as you noted, my name is Doris Hansen. I work at Moffitt Cancer Center in Tampa, Florida, and I’m a multiple myeloma specialist.  

Katherine Banwell: 

Thank you so much for joining us today. 

I’d like to start by discussing your role as a researcher. You’re on the front lines for advancements in the myeloma field. What led you here, and why is it important to you?  

Dr. Doris Hansen: 

That is a great question. I do have a close family member that was diagnosed with cancer. Actually, my mother. And it’s had a big impact in my life and in my career moving forward. So, I’ve really wanted to dedicate my life to – and I’ve also been very interested in hematology and oncology ever since training, but my mother further pushed me into developing this career path. So, I’ve been very passionate about oncology in general, and multiple myelomas, and incurable disease as it is now. But to help forge the path to eventually get to a cure and get our patients feeling better, and the most up-to-date, innovative, and revolutionary treatments, and some of those we have today. 

Katherine Banwell: 

That’s great. Choosing CAR T-cell therapy is an important decision. So, it’s essential to work with your healthcare team when making this choice. As a clinician, how do you define “shared decision-making,” and how does this elevate someone’s care? 

Dr. Doris Hansen: 

I think it’s very important when we discuss with our patients. Certainly, we’re here to provide the information to our patients regarding different medical treatments. For example, one of those I give are transplant or different immunotherapies, such as CAR T-cell therapies. But I think it’s important for us to discuss with our patients, “What are these therapies?” How efficacious they are. But in addition to that, “What are some side effects that these therapies might have that will impact their quality of life, the duration of their response, and also, their caregivers, their care partners, their family members, etc.?” And then, “What might be some alternatives to some of these treatments?” 

 So, I think being able to inform the patients, but ultimately, giving the information, and also letting the patients tell us, “What is important to our patients?” 

How can we move forward with the best possible treatment that fulfills, their needs, or what they are looking most forward to in terms of improving outcomes?” So, I think it’s definitely a shared decision-making with our patient leading the way, and us supporting them in the background. 

Katherine Banwell: 

Before we go any further, I’d like to talk about the basics. What exactly is CAR T-cell therapy? 

Dr. Doris Hansen: 

That’s a great question. So, CAR T-cell therapy’s really a revolutionary therapy for multiple myeloma. It’s a type of treatment where we collect a patient’s own white blood cells, or a type of white blood cell known as a T cell, and we essentially genetically manufacture that cell so that it represents, or has active antimyeloma properties, or antimyeloma proteins. 

So, when those CAR T cells, or genetically modified cells, are infused back into the patient, every time that those car T cells see a myeloma cell, they become activated, and they become activated to destroy the cancer. In theory, as I’d like to think about these, these are like your soldiers against myeloma, or your superpowered, superwomen, supermen, to kind of go after the bad guys, after the myeloma. 

Katherine Banwell: 

What are the goals of CAR T-cell therapy? 

Dr. Doris Hansen: 

So, the goal of CAR T-cell therapy’s really to get the deepest level of response that we can with this treatment. For example, for a patient with multiple myeloma, the goal would be to get them into a complete remission without any evidence of measurable residual disease, or to get them in, as we call it, MRD-negative status.  

And really, in patients who are able to get that type of response, the goal would be to really be treatment-free for as long as possible. One of the immunotherapies that we have available now is called ciltacabtagene autoleucel, or cilta-cel, or Carvykti, as some might know it. 

But that treatment, some recent data was presented that basically showed the median duration of response or survival was five years, and we saw that a third of those patients were really still in remission. So, treatment-free and without evidence of disease at five years, and these were heavily pretreated patients. And we have never seen anything like that in myeloma. So, really, the goal is, get the best response, and hopefully treatment-free as long as possible, so our patients can have a good quality of life. 

Katherine Banwell: 

So, this is one CAR T-cell therapy. What are other currently approved therapies, and which patients are they most appropriate for? 

Dr. Doris Hansen: 

That’s a great question. So, there are currently two FDA-approved CAR T-cell therapies. There is idecabtagene vicleucel, or a Abecma, which was first FDA approved in 2021. And then, as I mentioned, we have ciltacabtagene autoleucel, or Carvykti, which was originally FDA-approved in 2022. 

But as of last year, 2024, both of these treatments have moved earlier into the treatment course. So, basically, our patients can get CAR T as soon as second line or third line of therapy, depending on their treatment history, on their exposure, how well the treatment, their prior treatment, is working. But these are the two CAR T-cell products that are available. But also, there are many others in development and in clinical trials. 

So, we have anitocabtagene autoleucel. So, that one, hopefully, will come into – or get FDA-approved in the next year, in 2026. And it looks very promising from an efficacy and safety perspective. And then, we also have another CAR T known as arlo-cell, or arlocabtagene autoleucel, and that one essentially targets a different area on the myeloma cells than all the other CAR Ts I’ve been talking about. So, it’s exciting as well. 

And certainly, we have many more ongoing clinical trials, where we might have CAR Ts that target two areas on the myeloma cell instead of one. And then, we have what are called allogeneic CARs, which are CARs that are manufacturing using a healthy person’s T-cells. And those are also in development, and in clinical trials. So, a lot is happening in the myeloma space, particularly the CAR T immunotherapy, and even bispecifics and trispecifics. So, a lot to look forward to as we forge a path towards a cure for our patients. 

Katherine Banwell:

That sounds really promising. What testing should be done before undergoing CAR T-cell therapy? 

Dr. Doris Hansen:

So, CAR T-cell therapy is an incredible treatment, and as noted, has really changed the way we practice and treat myeloma, it is complicated. There are several steps that we have to take to make sure that the patient is healthy enough, and there are no medical issues or problems that could create safety concerns for patient down the road. 

But generally, testing includes – it’s very extensive. It includes checking your heart and your lungs, and we look at liver. We look, as well, at disease restaging. So, that will include a PET scan to see how much myeloma we have, and it will also include a bone marrow biopsy to also assess the level of multiple myeloma cells that might be in the bone marrow. In addition to just laboratory values to assess myeloma protein light chains, as well as just our general CBC, which looks at your red blood cells, your white blood cells, as well as your kidney and liver function, among other things. 

Katherine Banwell:

When someone is making the decision to undergo CAR T-cell therapies, a therapy, rather, what factors should be considered, as far as age – 

Dr. Doris Hansen:

Yeah, that’s a great question. I do believe that there is transplant eligibility, and then there’s CAR T eligibility, and I can’t say that those two things are really the same. 

Generally, I would say that most patients are CAR T eligible, and should be assessed by a CAR T, or an immunotherapy, or academic treatment center. Because, for example, as you mentioned, age. Well, really, what we’ve seen – although this might be a bit biased. But older patients tend to do just fine with CAR T-cell therapy. They have nearly equivalent outcomes, if not better, in terms of efficacy, and they do okay with the right supportive treatment. So, I don’t think age is a problem. 

Certainly, I might consider if somebody – there’s also logistical considerations. So, if somebody does not have a caregiver, that might be a logistical issue. Or if somebody might have disease that is relapsing very fast, we might need to do another treatment first before we go to CAR T to prevent any complications. Or if a person can’t get to an academic center. 

But generally speaking, we do have support programs. The companies have support programs to really help our patients with travel, logistics, lodging, all of these things, to really be able to get some of these lifesaving therapies. 

Katherine Banwell:

Dr. Hansen, what questions should patients ask their team about CAR T-cell therapy? 

Dr. Doris Hansen:

I think it’s really important to be able to understand, “How well does this CAR T work? What is its potential for long-term benefits?” But also, most importantly, “What are some side effects from this treatment? And how do those side effects look in the short term? How might that look in the long term? What are the different CAR T treatment options that might be available to you? What might be happening in the clinical trial space? Are there any clinical trials that you might be eligible for? And also, what might be some alternatives?” 

And one important question that is currently in the myeloma space is – well, we have, as I mentioned, we have CAR Ts. We have bispecifics. Now, we have some trispecifics. Basically, those are immunotherapies that targets three different areas. But how should we sequence them? Which one should we give first? What is the best way to sequence them, so our patients get the most benefit? 

So, I think just being aware of what is available, commercially approved, what’s in clinical trial, and what might be the best way to sequence these types of treatment? And what are the logistical considerations as well, as we move forward with these immunotherapies? 

Katherine Banwell:

You mentioned side effects. What are the side effects of CAR T-cell therapy? And why do patients and their care partners need to be aware of what to expect? 

Dr. Doris Hansen:

That’s a great question. 

So, I think, regardless of what CAR T-cell therapy patients might choose, whether it’s something on clinical trial, or something that is commercially approved, I would say that there’s generally at least two universal side effects from these treatments. 

So, majority of patients will have what is known as cytokine release syndrome, or CRS. Which, the way I describe it to my patients, is having the flu. You have a high-grade fever, so you might have some body aches. You might have a headache. Generally, this is very mild, and it’s what we call Grade 1. But sometimes, it can be more severe. But I’d say this is more universal to any CAR T treatment. 

In addition, patients will have low blood counts from all CAR T-cell treatments and will take a bit of time to recover. And when there are low blood counts, obviously, we have to be very careful and mindful of any infectious complications, and we support our patients with antibiotics and such. 

Now, other side effects from CAR T include neurologic toxicity. So, these T cells do cross the blood-brain barrier, and they can cause what is known as ICANs, immune effector cell-associated neurotoxicity. 

And really, what that presents as, it might be confusion, tremors, wordfinding difficulty. This has, in the commercially approved products, this has occurred in up to 20, 17 to 20 percent of patients. But generally, it’s reversible, and it’s low grade. Rarely, it can be more severe. 

With, particularly, I would say, Carvykti, and some of the CAR Ts on clinical trial, there are what we call non-ICANS neurologic toxicity. So, the unusual neurologic toxicities. They can manifest, for example, as Parkinson’s. So, similar to what you might see with Parkinson’s disease. Generally, if we give CAR T earlier, as I mentioned, in second or third line, the risk of getting this with Carvykti, for example, is very low. But nonetheless, it’s there. It’s about 1 percent, or less than 1 percent. And then, the risk of getting what we know as cranial nerve palsy. 

So, something as Bell’s palsy, where you might have a droopy mouth. or a droopy eye. Generally, that is reversible in 60 to 70 percent of patients. But with Carvykti, in early line, it occurs in about nine percent of patients in clinical trial. With arlo-cel, there is what is known as cerebellar toxicity that is still in development, but it can present as dizziness or unsteadiness. But nonetheless, the likelihood of having these symptoms, or these more aggressive toxicities, generally, it’s very low. 

There’s also long-term follow-up and monitoring, because our patients are generally older and they’ve had a lot of treatments. So, we have to be very mindful in the long term about monitoring what we know as second primary malignancies, or developing another secondary cancer, following the CAR T. And last, but not least, there was a recent update to the FDA label for Carvykti, which includes what is known as IEC. So, immune effector cell-associated enterocolitis. 

So, this just represents as diarrhea, on average, about 90 days or three months following CAR T. The incidence, or the likelihood of something like that happening, is only about 1 to 2 percent, but nonetheless, is a toxicity that we should consider as we counsel our patients with this treatment. 

Katherine Banwell:

One person who’s very important, plays a big role in the healthcare team, is the care partner. So, tell us why a care partner is essential. 

Dr. Doris Hansen:

A care partner is so important. Generally speaking, my patients, when we move forward with CAR T, we do require a care partner, or someone who can be with you. Because at our institution, and I think a lot of major academic institutions, CAR T is given in the outpatient setting. Essentially, patients come in, they get their chemotherapy. They get their CAR T infusion. And then, they get discharged to facility that is close to our institution. 

And they are generally mandated to be in proximity of the institution. In the past, it used to be 30 days. Now, with some new FDA guidance, it’s at least two weeks. But a care partner is important because they might help our patient in different ways. For example, if our patient has a fever, they could help give us a call. They might go to the pharmacy and pick up their medications. Or they might go to the grocery store and might help our patients with making meals or support our patient in any way that they can. 

I don’t expect that our patients with CAR T will be – they should be able to walk. They should be able to come to the treatment center and do all of their daily activities. It’s just, sometimes, a lot of us need help, especially undergoing such a major procedure, to help guide us along the way with certain things. Like I said, cooking. Or if you are feeling unwell, to let us know, and those types of things. And also, driving the patients. 

Because, as it stands, generally, we’d recommend that a patient receiving CAR T does not drive for at least two weeks following CAR T-cell infusion. It used to be eight weeks, but thankfully, that has been rolled back to about two weeks post-infusion. 

Katherine Banwell:

Dr. Hansen, CAR T, of course, has been around for several years now. Are there innovations in improving the patient experience when they’re undergoing CAR T-cell therapy? 

Dr. Doris Hansen:

There are. There’s actually a lot happening. So, when CAR T first got approved, it used to be given in the inpatient setting. Because we wanted to monitor our patients very closely for any safety outcomes, like I mentioned, the CRS and the ICANs, or any other additional problems. However, recently, we’ve seen that we do not need to keep our patients in the hospital for a week, or two weeks. That did appear to be excessive. Currently, CAR T is given in the outpatient setting, which is, I think, nice for the patient. 

They’re able to go outside. They’re able to sleep in a bed that’s not a hospital bed, eat meals that might not be hospital meals. So, I think it’s nice in that regard. But also, we’ve also incorporating a lot of patient-reported outcomes.  

So, we have a lot of studies, actually, that we give our – patient we talk to our patients, right? About their experience, and “What can we do to make this better?” So, having this patient-reported outcome surveys where we ask our patients different questions throughout their treatment journey, so that we know how to improve their experience, or hear directly from our patients. So, we have several ongoing studies that look at that as well.  

And then, there’s some discussion, and some of the centers also do this, where you have, kind of monitoring device that can monitor for fevers, and change in your heart rate, and blood pressure, and things like that. 

So, there’s a lot that’s happening, especially with AI and different devices, where we can directly get the information about, “Is somebody about to have a fever?” Things like that. So, I think science is really advancing forward. But really, the most important first step is moving CAR T to outpatient, and hearing from our patients about how we can improve their experience. 

Katherine Banwell:

Why is it essential for patients to share any issues they may be having with their care team? 

Dr. Doris Hansen:

I think it’s very important. We always tell our patients that, “Anytime you see something, or let’s say you have a headache, or you start to have body aches, any type of side effects, we prefer that they’re reported to us.” Because then, we’ll check the bloodwork and see, “Are there inflammatory markers rising?” Because that could tell us, “Maybe somebody is about to develop a fever, or somebody is about to develop CRS.”  

So, I think it’s really very important to communicate closely with the medical team, because we prefer to be conservative and try to intervene sooner rather than later to make sure that our patients have the best outcomes.  

Katherine Banwell:

That’s great advice. Thank you. I’d like to get to a few audience questions that we received before the program. This one comes from Craig. He says, “I’m not ready for CAR T-cell therapy at this time. But thinking about the future, are there previous therapies that may make me ineligible for CAR T-cell therapy?” 

Dr. Doris Hansen:

No. So, that’s really a great question. So, currently, as it stands, patients have to have, for example, exposure to certain medication, and certain classes of medications, to be eligible for it. But having more treatments doesn’t necessarily make you ineligible to receive CAR T. We generally do not recommend to receive CAR T later in the disease course, per se. 

Because if we are able to give it earlier, when the T cells are a little bit fitter and healthier, and when we’re able to get the disease when it hasn’t developed more resistance and more mutations, we hope to get kind of a better and deeper response with CAR T earlier in the disease scores. But I don’t believe that any treatments will make you ineligible, but some treatments and the proximity to CAR T might impact how well the CAR T works. So, I do think it’s very important and mindful to discuss with your provider, “What treatments are we considering?” and what might make the CAR T work less well. 

Katherine Banwell:

Right. Rachel sent in this question. “While CAR T can be a good option for treating my myeloma, I know it may not be a cure. What are my options if the disease returns?” 

Dr. Doris Hansen:

That’s a great question, actually. As you mentioned, CAR T is a great treatment. We are not necessarily at a cure quite yet, but as I noted, we have a lot of ongoing clinical trials. 

Just because somebody has had one CAR T, that doesn’t mean that you cannot have another CAR T down the road. As I mentioned, we have dual CAR Ts. We have CAR Ts targeting a different area on the myeloma protein. So, certainly, having another CAR T is an option on clinical trial. 

But then, we also have other immunotherapies. As I noted, we have bispecific therapies, which are ready. Treatments you don’t have to wait for T-cell manufacturing. There are four of them that are currently FDA-approved, and we have several in development and in combination with other drugs. 

And we also have what’s called a trispecific, where you continue to essentially target more molecules or proteins on the myeloma cells. And that’s certainly something very promising that’s coming down the pipeline, in addition to other novel agents. Something like CELMoDs, and other drugs. But there is a lot more than we can do, even if the myeloma might relapse after CAR T, including a repeat CAR T on clinical trial, among other options. 

Katherine Banwell:

Thank you for that, Dr. Hansen. 

Dr. Doris Hansen:

Course. 

Katherine Banwell:

Those were great questions. Please continue to send them to question@powerfulpatients.org, and we’ll work to get them answered on future programs. So, Dr. Hansen, fighting any disease, of course, requires a holistic approach. When someone is undergoing CAR T-cell therapy, what advice do you have for managing the physical and emotional effects of the treatment? 

Dr. Doris Hansen:

That’s a great question. We do have support teams here. Actually, we do have an exercise program that is ongoing in clinical trials, what we call prehabilitation. But I do think that being active during the CAR T process is very important. We actually, in fact, encourage our patients to walk a mile per day at least, and a lot of my patients actually do more. But we also have support in many other different ways.  

We have social workers who actually are wonderful and able to discuss some of these concerns with our patient, in addition to all of us, of course. And we have other – we have music therapy. We have massage therapy at our center. So, there is a lot of different ways that we are able to support our patients through this process, to really help them get the most benefit, and hopefully, with the least side effects, and the best patient-reported outcomes.  

Katherine Banwell:

Is there a social worker or psychologist, psychiatrist on the healthcare team? 

Dr. Doris Hansen:

Yes, absolutely. So, those, particularly a social worker, a case manager. We do have psychiatrists and psychologists, but they are essential members of our care team. So, when we see our patients each day, it is a big team. It’s composed of the physicians, of physician assistants, of nurse practitioners, of our nursing staff, of our social worker, of our case manager, our pharmacists. 

So, it’s a really big team that will take care of you during this process. 

Katherine Banwell:

Are there resources available for people? 

Dr. Doris Hansen:

Most certainly, there are resources available. I do think that each institution, and generally, I can speak for our institution, we have a packet of information, right? Where we tell you about, “What is CAR T?” We direct you and give you information, and you’ll speak with our social workers. And as you might know, of course, there are resources available online as well, through the International Myeloma Foundation, through Leukemia & Lymphoma Society, and many other groups, that also have a lot of great information as well. But certainly, we have all of that information for our patients once they see us.  

Katherine Banwell:

That’s great news. Something that’s on the mind of many of our viewers is financial concerns. Everyone’s situation is different, of course. But where can patients turn if they need resources for financial support? 

Dr. Doris Hansen:

That’s a great question. And financial toxicity is a big problem with a lot of these therapies, particularly novel immunotherapies. We, generally, before we proceed with a CAR T-cell therapy, we will work with our insurance folks to help, really, to help our patients manage the financial side of things, but also, the companies. 

So, the companies that manufacture the CAR T cells, the two of them right now that are FDA-approved, they do have support for our patients. So, they generally – there’s an application form. They will work with you. But a lot of time, they will cover travel. They might help with lodging. And sometimes, obviously, on clinical trial, there will be meal support, and those types of things. But there are support systems out there. Sometimes, our patients might not know about it. So, I think it’s important to ask about what support mechanisms we can have for you, in addition to grants from other societies as well.  

Katherine Banwell:

Wow. Thanks for that information. PEN also has a financial resource guide on their website, along with a number of other resources. You can find these at powerfulpatients.org, or by scanning the QR code on your screen.  

As we close out the program, Dr. Hansen, what would you like to leave the audience with? Why are you hopeful? 

Dr. Doris Hansen:

Well, I treat myeloma, and we know myeloma is an incurable disease. But what makes me, every day, happy to come to work, is that I’m able to care for my patients, and we have so many innovative and novel clinical trials. And now, in myeloma our field, has definitely changed. We’re giving patients immunotherapies earlier in the treatment course. We’re able to get our patients off of treatment for many years, so they can live their lives, and be with their family, and work and enjoy what they like to do.  

And I’m very hopeful that, in the near future, with all that is available, and with all the wonderful science that is ongoing, that we will hopefully forge our path towards a cure for our patients. 

Katherine Banwell:

That’s a promising outlook, Dr. Hansen. Thank you so much for joining us today.  

Dr. Doris Hansen:

Thank you for having me.  

Katherine Banwell:

To learn more about CAR T-cell therapy, and to access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell. Thanks for joining us. That was wonderful.