CAR T-Cell Therapy Archives - Page 2 of 14

A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

May 13, 2024/in [ACT]IVATED CAR T, [ACT]IVATED CAR T Expert, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

A Look at Promising Strategies to Improve CAR T-Cell Therapy Access from Patient Empowerment Network on Vimeo.

How can CAR T-cell therapy access be improved? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center explains strategies that have increased CAR T access, monitoring of CAR T patients, and advice for patients to access support.

[ACT]IVATION TIP

“…talk to your teams, if it’s not the doctor, at least the nurse practitioner or the nurses about resources, because through the pharmaceutical companies as well as things like LLS and other places, they actually have funds for people going through trials or CAR T therapies, etcetera, that we can help. My nurse knows all these things that she knows how to start working in our social worker and our case managers, they all know all these things so that they can get you the resources you need…”

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Are CAR-T Clinical Trials Studying Use As a Frontline Therapy?

Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

Transcript:

Lisa Hatfield:

Dr. Patel, given the exacerbation of existing barriers during the COVID-19 pandemic, what strategies do you believe are most promising for enhancing patient access to CAR T therapy, particularly in terms of innovative clinical trial designs and stakeholder collaboration? And one of the questions that comes up a lot is during COVID I was able to participate in a clinical trial, but I could do some things closer to home where we don’t have a big center. Are those strategies still in play? So patients might be able to travel, maybe once a month or once every two months for a CAR T trial and then go home for a little while. Can you talk about that a little bit?

Dr. Krina Patel:

Yeah, I think COVID did help us learn how to use telehealth much more, where when it was allowed, I think the good news when we had it, we could do it for all 50 states. It was amazing. All my patients I could talk to through virtual visits, etcetera, use their local labs. Clinical trials are a little harder because you have to have labs that are certified and making sure that they’re able to do those intricate labs that you need.

For instance, certain things are central labs for where they have to look at your T cells and how they’re expanding over time while you’re getting CAR Ts. So we call those central labs because those are labs we draw and send to the company, to whatever lab they’re using to help with that stuff. Things like CBC, your blood counts, your kidneys, liver. Yes, those things are easy to get anywhere. There are multiple labs like Quest and Labcorp, etcetera, that can do those.

So I think those are things that we can help with. It’s the first 30 days of any CAR T study that for safety reasons right now, we still say you have to be at the center where you’re getting the CAR T on trial or even off a standard of care. And that’s more for if you get one of these toxicities like the delayed neurotox or an infection, that we can get you back into the hospital if needed or at least get you diagnosed really quickly and treated quickly.

But yes, after those 30 days, at least most of our CAR T studies really try to limit how often you have to come in. So once a month is pretty typical and then once every three months after the first couple of years, and then once a year if that. I hope that with the FDA and with our sponsors, our pharmaceutical companies that run these trials, that they can really help get these things, the logistics figured out, because that’s what it ends up being. Once you’re done with your first at least three months of CAR T, we know patients are going to do well. And it’s really about whatever labs and visits we need to do, how can we do them virtually? And again, if my sponsors and the FDA would allow that, we’d be really happy to.

And I know the FDA is all for it. They are trying to help increase access as well. And so some of the bigger centers like us, and I think Sloan Kettering and City of Hope and Mayo, we also have other centers that are outside of the main campus. So MD Anderson doesn’t have other hospitals the way Mayo does. So Mayo has Arizona, has Rochester, and Florida. MD Anderson has a sister network.

And so we’re hoping to tap into that one day, because there are places everywhere. And if we can do that, that would actually help get access to a lot of these novel therapies a lot faster to our patients. And within Houston, just being such a big city, we have four other centers out in the outskirts and we are trying to actually increase our abilities to do therapies there as well, including CAR T and bispecific therapies.

Lisa Hatfield:

Thank you for that, Dr. Patel. So one question, I have a follow-up question. If a patient has to travel, maybe they live in an area where there is no academic center, they’d have to travel for a clinical trial. And you mentioned the first 30 days. Are patients usually, one of the big challenges is financial, is a financial challenge. Are patients sometimes feeling well enough during that 30 days if they can work remotely? Can they work remotely while they’re at your institution for 30 days? Is that pretty typical or is that something you don’t see very often?

Dr. Krina Patel:

Yeah, no, that’s a great question. So we are trying to make the whole thing outpatient soon, and a lot of our trials are allowing for CAR T outpatient, and only if you get a fever, then we admit, most people do get admitted because most people get fevers from the CAR T, but for the most part patients still feel well, it’s not that they’re having this horrible nausea, vomiting, diarrhea, things that we think about with auto transplant, where people really can’t work because they’re just exhausted. The majority of our patients are bored in the hospital, it really is that we’re just there just in case the fever turns into something worse. So a lot of my patients who are still working actually do work remotely, I can think of a few just this past week that talked about the fact that they were able to do this.

And I think the other piece we have so many resources. And again, the big activation tip here is talk to your teams, if it’s not the doctor, at least the nurse practitioner or the nurses about resources, because through the pharmaceutical companies as well as things like LLS and other places, they actually have funds for people going through trials or CAR T therapies, etcetera, that we can help.

My nurse knows all these things that she knows how to start working and our social worker and our case managers, they all know all these things so that they can get you the resources you need and some of the centers, our academic centers have resources as well. We have housing for free, you have to sign up for it in advance, but you might be able to get housing for free for that whole 30 days, and so there’s a lot of different resources that you just have to ask about, and then again, through our social worker, case manager, nurses, and sponsors. We can actually get some of that for you too.

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How Can Variable Patient Groups Be Addressed in CAR T?

May 13, 2024/in [ACT]IVATED CAR T, [ACT]IVATED CAR T Expert, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

How Can Variable Patient Groups Be Addressed in CAR T? from Patient Empowerment Network on Vimeo.

Can CAR T-cell therapy address variable patient groups? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses variances in different myeloma patient groups, the KarMMa-3 study, and proactive advice for patients.

[ACT]IVATION TIP

“…if you are in a area, let’s say rural America where you don’t have access or you are in a minority population, African American, Hispanic, etcetera, or older, frail patients who are older that are considered vulnerable as well, absolutely make sure to talk to your doctors about these novel therapies because you still can get them safely and they will work. They can work. You just have to go to a center where they know how to adjust those types of therapies to make sure you get the best options out there as well.”

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See More from [ACT]IVATED CAR T

Related Resources:

What Patient Types Are Good Candidates for CAR T-Cell Therapy?

Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

Transcript:

Lisa Hatfield:

Dr. Patel, how might the heterogeneity of patient populations impact the standardization and reproducibility of CAR T therapy outcomes across different clinical settings, and what initiatives are in place to address this variability?

Dr. Krina Patel:

Yeah, I think that’s a great question because again, this is a personalized therapy. So it depends on what your myeloma is like, the genomics, the genetics of your myeloma, how aggressive is it, plus your T cells, right? And so everybody’s genetic ancestry, etcetera, is very different. So the idea of a personalized medicine, more than just even across groups of people, it’s at the individual level. And I think when you talk about different races or ethnicities, we have seen some differences in our real-world data, in very relapsed/refractory patients, where people can get great response rates still.

So, for instance, Caucasian patients versus African American patients, our response rates are still high in the 80s and 90 percent, but the toxicity is a little bit higher in our African American patients. It’s still not high grade. It’s not anything that makes me say, I’m not going to give this, but the baseline inflammatory markers are a little bit higher. And so once we get the CAR T, our patients tend to get a little bit more CRS.

They end up in the hospital a little bit longer. Now, again, this is a multivariate analysis and we couldn’t find any other difference, but when we look at KarMMa-3, which is one of our big studies that led to ide-cel (idecabtagene vicleucel) [Abecma] being approved early, we actually had an outcomes of African American patients only that we looked at and that we presented just this past TCT, and response rates were actually a little bit better.

Again, you can’t compare them because the numbers aren’t there to power that to compare, but numerically the numbers were better in terms of response rate, in terms of progression-free survival, it was actually more months that it beat the standard of care and we didn’t see more toxicity.

And so I think we do need to look at these things and make sure there’s not one group of patients has a lower efficacy for some reason, and why is that and how can we improve that? And so far, we don’t really see that. And the other is the toxicity piece, to make sure that these therapies that do cause some strange toxicities that we’re watching and seeing who might be more vulnerable to those toxicities, who do we need to maybe even prevent, do prevention strategies for, but so far we haven’t seen it.

And then I think coming back to the individual, right?So again, all of us have these different T cells that have different mutations in them, and some folks, for some reason, even with less myeloma, their T cells just expand really fast and other folks, they don’t. And so in the future to get best outcomes, we need to see how we can turn the volume lower for those folks who have really sensitive T cells.

And for those who don’t, how do we, what else can we add in combination to actually increase those T cells so that they’re actually doing a better job at killing the myeloma, right? And including the microenvironment too. So I think there’s a lot of translational work as well as the epidemiology side of things to say, okay, how do we first diagnose the problem, find the problems, and then how do we figure out how to intervene to then improve outcomes for all our patients? I think the activation tip here is that if you are in a area, let’s say rural America where you don’t have access or you are in a minority population, African American, Hispanic, etcetera, or older, frail patients who are older that are considered vulnerable as well, absolutely make sure to talk to your doctors about these novel therapies because you still can get them safely and they will work. They can work. You just have to go to a center where they know how to adjust those types of therapies to make sure you get the best options out there as well.

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What Patient Types Are Good Candidates for CAR T-Cell Therapy?

May 13, 2024/in [ACT]IVATED CAR T, [ACT]IVATED CAR T Expert, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

What Patient Types Are Good Candidates for CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.

For CAR T-cell therapy, what patient types are good candidates? Expert Dr. Krina Patel from The University of Texas MD Anderson Cancer Center discusses patient situations that qualify them for CAR T-cell therapy and shares proactive patient advice.

[ACT]IVATION TIP

“I think a lot of people have this misunderstanding that CAR T isn’t for everybody, but I will say it’s actually more likely that you’re going to be eligible for CAR T over auto transplant. So I think it’s just bringing it up, talking to them, and seeing a specialist to discuss which ones are the right one for you and when to go.”

Download Guide | Descargar Guía

See More from [ACT]IVATED CAR T

Related Resources:

How Can Variable Patient Groups Be Addressed in CAR T?

Are There Myeloma Trials Investigating CAR T for Frontline Therapy?

A Look at Promising Strategies to Improve CAR T-Cell Therapy Access

Transcript:

Lisa Hatfield:

Dr. Patel, given that CAR T is approved for earlier lines of therapy, can you describe the type of disease characteristics of patients that are likely to be considered first for CAR T?

Dr. Krina Patel:

Yeah, I think it’s a really exciting time, we got approval for two different CAR Ts that were approved in fifth line. So patients had to relapse four times before they could get to CAR T therapy. And now one of them, cilta-cel ciltacabtagene autoleucel [Carvykti], is approved in second line, so people have to relapse once before they can get it.

And the other CAR T, ide-cel (idecabtagene vicleucel) [Abecma], is approved in third line, so you have to relapse twice. There are reasons why that is the way it is, but both of these CAR Ts are pretty fantastic, and we’re really excited that more patients will now have access. As you can imagine, relapsing once, it’s already hard enough to then say, okay, I need a different therapy, but to go through four times before you can do something like CAR T is really, really important.

So I think the biggest characteristic, and I would say for my patients, it’s really their ability to keep their myeloma controlled for at least six to eight weeks, potentially, right? Because this is a personalized therapy, unlike most other myeloma therapies where we have to take the T cells out, we have to then send them to a lab to make the CARs, then it takes about four to six weeks to get them back. During that time, I just have to know that your myeloma can stay controlled or even improve with whatever bridging therapy we decide to do during that time.

And we know that when patients have myeloma that is on its way down, that it’s actually improving, by the time they get to the CAR T therapy, the infusion part, they tend to do better in terms of efficacy, but also have less toxicity. So there’s a few different toxicities that we can talk about with CAR T that are very distinct compared to most other therapies, that again, if you have less disease burden, the rates of that toxicity and the high-grade toxicity goes away, right? It’s much, much lower than if you have a lot of myeloma coming in.

So, again, for my patients who have disease that I know I have other therapies to keep it knocked down or to knock it down during that bridging, that really is the main difference between, can I take this patient to CAR T or not? But I think there’s some nuances too, again, that idea that one CAR T is approved in second line, another one is approved in third line, I do think they’ve never been tested head to head, so we don’t have data in a clinical trial, but in the real world, we’ve used both of these products, a lot of us have, and I think most of us will say that one of the products is probably stronger, it probably works better cilta-cel, and that is the one that’s approved in second line, which is great.

So for my fit patients who don’t have a lot of comorbidities, who do really have high-risk disease that I need to be as aggressive as possible and do something very different, hands down, it makes sense that cilta-cel is the right thing to do right at second line, but the toxicity is also a little bit higher with that, meaning that patients are more likely to potentially get some of these strange neurotoxicities that we see, that we didn’t really see before with other therapies, some of our myeloma patients get neuropathy and we think about that as neurotoxicity, but this is different.

This is more patients after 30 days of having had their T cells can all of a sudden get a facial palsy where they’re having drooping of their face and it can affect their eating and their speaking. Now those things are not fatal, we can treat it with steroids, things like that, but they can affect your quality of life. And if it doesn’t resolve, that can affect down the road, all the other therapies we want to give you, right? But the more dangerous one is something called delayed Parkinsonianism or delayed motor neurotoxicities.

And again, we know the best prevention of that is decreasing the myeloma burden before going to CAR T, but if we can’t do that or some patients can still potentially get this Parkinsonianism, we really want to make sure there’s a risk-benefit discussion, right? That we say, okay, this is why we should go in second line.

Again, the risk is less than 1 percent now based on how we’ve done things for prevention. But on the other hand, with ide-cel, most of our patients, even on dialysis, our patients that are getting CAR T and doing well, patients with heart failure, I’ve had a 90-year-old go through ide-cel without any issues and have great responses. So I think both of these offer, one of the first times they offer time without any therapy for myeloma. And so I would say this is something most of my patients should ask their physicians about, but really then it’s nuanced in terms of when we should do it and which product.

Lisa Hatfield:

Okay, thank you. And do you have an activation tip for that question, Dr. Patel?

Dr. Krina Patel:

Yeah, so I think the activation tip here is bring it up, bring up CAR T to your doctors, right? I think a lot of people have this misunderstanding that CAR T isn’t for everybody, but I will say it’s actually more likely that you’re going to be eligible for CAR T over auto transplant. So I think it’s just bringing it up, talking to them, and seeing a specialist to discuss which ones are the right one for you and when to go.

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Understanding Myeloma Therapy Targets BCMA and GPRC5D

April 22, 2024/in Evolve CAR T, Evolve CAR T Process, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

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.

See More from Evolve CAR T-Cell Therapy

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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?

April 22, 2024/in Evolve CAR T, Evolve CAR T Advances, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

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.

See More from Evolve CAR T-Cell Therapy

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

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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.

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

April 22, 2024/in Evolve CAR T, Evolve CAR T Process, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

How Can Myeloma Patients Access CAR T-Cell Therapy Clinical Trials? from Patient Empowerment Network on Vimeo.

How can patients learn more about joining myeloma CAR T-cell therapy clinical trials? Dr. Krina Patel shares advice for identify and accessing these trials, noting that seeking care with a myeloma specialist can be most helpful.

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 Evolve CAR T-Cell Therapy

Related Resources:

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

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

Understanding Myeloma Therapy Targets BCMA and GPRC5D

Transcript:

Katherine:

How can patients find and access clinical trials that are looking at CAR T-cell as an earlier line of therapy?

Dr. Krina Patel:

That’s a great question. So, I think going to any place that is myeloma specific. So, basically a big center that has doctors that are doing myeloma research, they will be able to definitely get you into places that have some of these trials. But clinicaltrials.gov is one other place. It’s really hard. I will tell you that, if I wasn’t a physician or in medicine, I don’t think I would learn, I would be able to navigate it very well.

And so, really either through your doctor and having them look this up for you, or going to patient groups. So, again, a lot of my patients are part of different patient groups where people will say, “Well, this is a trial that I was” or “This is a trial that my doctor told me about.” And then, asking. So, that’s the other big thing is constantly asking your doctor “What are my other options?” getting second opinions from myeloma experts, and then just paying attention to some of these resources that you have available. Right now, there are gonna be more clinical trials for earlier-line therapies and first-line with both cilta-cel and ide-cel.

There’s going to be clinical trials with new products: ddBCMA CAR T, that is likely gonna come out soon for earlier-line therapies. And so, there’s a lot happening, and so there might be different clinical trials in different places. But I think the fact that all this is going on at once is really important for our patients to know about.

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

April 22, 2024/in Evolve CAR T, Evolve CAR T Advances, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

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.

See More from Evolve CAR T-Cell Therapy

Related Resources:

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

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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

April 22, 2024/in Elevate Myeloma, Elevate Myeloma Advocacy, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

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.

See More from Elevate Myeloma

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Accessing Quality Myeloma Care | Advice for Overcoming Obstacles

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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

April 22, 2024/in Elevate Myeloma, Elevate Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

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.

See More from Elevate Myeloma

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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.

Evolve Multiple Myeloma Resource Guide

April 22, 2024/in Evolve Myeloma, Evolve Myeloma Advocacy, MM Newly Diagnosed, MM Programs, MM Resources ND, MM Resources TC, MM Treatments and Clinical Trials, Multiple Myeloma /by Kara Rayburn

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Advances in Managing CAR T-Cell Therapy Side Effects

April 22, 2024/in MM Newly Diagnosed, MM Programs, MM Thrive CAR T, MM Thrive CAR T Understanding, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

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.

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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.

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

April 19, 2024/in Elevate Myeloma, Elevate Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

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

How does bispecific antibody therapy impact the outlook for myeloma care and treatment? Dr. Krina Patel discusses how this treatment, and CAR T-cell therapy, are revolutionizing myeloma care.

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. Learn more about Dr. Krina Patel.

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Transcript:

Katherine:

What role do you foresee bispecific antibody therapies playing the future of myeloma care?

Dr. Krina Patel:

So, I think bispecifics are phenomenal. I’m a CAR T girl, but in terms of access, I will say, that more of our patients around the world are going to have access to bispecifics.

And it’s off the shelf, so you don’t have to worry about taking cells out, making it, waiting and hoping to get those cells back. So, many more patients are going to be able to get it. And I think ideally if everybody could get a CAR T, my goal would be a CAR T first and then a bispecific until we can cure myeloma. Unfortunately, for the most part right now with these therapies, as single agents we haven’t seen that the majority of patients are cured.

So, my goal is to make sure that I have all the treatment options possible to keep patients doing well for as long as possible. And so, again, ideally CAR T, then maybe a bispecific because of the way those resistance mechanisms happen. But if we don’t have the availability of CAR T for everybody or you’re not eligible, I do think bispecifics are a great therapy. And I have again patients who are frail, who are older that we’ve been able to give bispecifics to and they’ve had amazing responses. And I think right now they’re single agents. But I do think that as we get these trials with combinations approved, we’ll see a lot more increase in use of those.

Again, the side effects are still something we’re learning about. So, bispecifics with BCMA, infections are a really big risk, even more than CAR T.

So, it’s really, really important that, if anyone has fevers or they don’t feel well, they see their doctor right way and make sure it’s not a strange infection that we don’t usually see that needs to be treated versus even a regular pneumonia that can be pretty dangerous when your immune system’s down.

So, that’s important. And then, the GPRC5D, as I said, it’s the taste and the weight loss and things like on skin that we really wanna make sure we do as much supportive care for that as possible.

What’s Next in Myeloma Research and Treatment?

April 19, 2024/in Evolve Myeloma, Evolve Myeloma Treatment, MM Newly Diagnosed, MM Programs, MM Treatments and Clinical Trials, MM Videos ND, MM Videos TC, Multiple Myeloma /by Kara Rayburn

What’s Next in Myeloma Research and Treatment? from Patient Empowerment Network on Vimeo.

What are the next generation myeloma therapies? Dr. Krina Patel shares an update on new agents, such as CelMoDs, and discusses how combination treatment and sequencing of therapy will evolve in the future of myeloma care.

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. Learn more about Dr. Patel.

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Transcript:

Katherine:

Dr. Patel, for the last few years advances in myeloma treatment have been focused on the cellular therapies like CAR T. Can you share what’s next in myeloma research and treatment?

Dr. Krina Patel:

Yes, I think it’s been really exciting. The last 10, 15 years, really, we’ve just catapulted in the whole world of immunotherapies; so, from monoclonal antibodies to even IMids and CelMoDs and things that we’ll talk about a little bit now, and cell therapy as well as just other ways of engaging T-cells with the bispecific therapies too. So, I think what’s really exciting, that we have not just new mechanism of action that’s coming down the road but new targets.

So, again, coming back to really the big stuff like immunotherapy that I really like a lot and what I really am excited about, we have different ways of using the immune cells to help fight myeloma.

And so, things like IMids, lenalidomide, and pomalidomide that are older drugs that we’ve had since 2006, but really there’s newer ones called CelMoDs that are coming out that are being evaluated in clinical trials. One is called iberdomide. Another is called mezigdomide.

So, we’re really excited about this really in combination therapy, just like the prior iMids were used. And what it really does is it improves your immune system; it activates it to a point where things like monoclonal antibodies, such as daratumumab or isatuximab or elotuzumab, can work better in synergy.

But even new trials with some of our CAR Ts that we already have available, the BCMA therapies, combining it with these to see if we can make those T-cells work better.

So, once you get the CAR T-cell infusion, can we give some of these therapies now to improve how long it lasts, how well they work. And the same thing with the bispecifics.

These are therapies that are using the T-cells that are already in your body. Can we combine it with some of these of other immune therapies that will help the T-cells already there get activated, and then the bispecific takes them to the myeloma to really get treated. And I think those combination studies that are coming down are really, really exciting. And then, I think the new antigens, as I mentioned, not just BCMA therapy but we have GPRC5D and we have something called FcRH5.

And to my patients, I say it’s alphabet and number soup basically but they’re really targets for myeloma that we’re finding. It’s pretty amazing, considering that we didn’t have a target for the longest time, like lymphoma when they had their CD19 and we were jealous. And now we’re finding all these targets and now we’re figuring out how do we combine different mechanism of action for different targets so that we can hopefully kill every last myeloma cell.

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

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

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

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

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

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Transcript:

Katherine:

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

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

Dr. Ailawadhi:

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

Katherine:

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

Dr. Ailawadhi:

Absolutely.

Katherine:

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

Dr. Ailawadhi:

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

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

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

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

Katherine:

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

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

Dr. Ailawadhi:

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

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

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

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

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

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

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

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

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

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

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

Katherine:

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

Dr. Ailawadhi:

Absolutely. Thanks a lot for this opportunity.

Katherine:

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

Next Generation Myeloma Treatment Options

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

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

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

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

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Personalized Medicine for Myeloma Treatment | What Patients Should Know

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What Should Myeloma Patients Ask About Developing Research?

Transcript:

Katherine:

Are there other emerging myeloma therapies that are showing promise?

Dr. Nadeem:

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

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

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

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

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

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

Katherine:

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

Dr. Nadeem:

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

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

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

Katherine:

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

Dr. Nadeem:

Yeah. That’s right.

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