Tag Archive for: CRS

What Do You Need to Know When Considering CAR T-Cell Therapy?

/in , , , , , , , /by

What Do You Need to Know When Considering CAR T-Cell Therapy? from Patient Empowerment Network on Vimeo.

How does one access myeloma CAR T-cell therapy? This animated explainer video provides an overview of the steps involved in determining whether a patient qualifies to receive CAR T-cell therapy, what the process entails, common side effects, and why having a care partner is essential.

See More From Thrive CAR T-Cell Therapy

Related Resources:

Understanding CAR T-Cell Therapy | How It Works and Who It’s Right For

Understanding CAR T-Cell Therapy | How It Works and Who It’s Right For 

 Understanding Possible Side Effects of CAR T-Cell Therapy

Understanding Possible Side Effects of CAR T-Cell Therapy 

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

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

Transcript:

The emergence of CAR T-cell therapy is revolutionizing treatment for some people with myeloma. But, who is it right for, and what is the process for people that qualify?  

  • The first step in accessing this treatment is to be referred by your physician to a center that specializes in CAR T-cell therapy. 
  • Then, a consultation will take place with the transplant team, and a health assessment is administered to ensure patients are healthy enough for CAR T-cell therapy. This includes testing to review the current status of your cancer and testing of your body’s major organ systems.
  • Next, the specialty center will evaluate the best type of CAR T-cell therapy for the patient, including clinical trial options.
  • After approval, financial coordinators will discuss insurance and therapy costs with the potential recipient. Logistics are also arranged at this time, which may include help with transportation and housing, if necessary.
  • Medical centers also require that patients have a care partner, such as a family member or friend, who can be with them at all times, particularly after leaving the hospital. 

So, what is the process once a patient is approved for CAR T-cell therapy? Once a patient is approved to move forward with the procedure, a date is set for collection of the patient’s T cells. T-cells are collected during a process called apheresis. During apheresis a specialized machine filters the patient’s blood to remove the T-cells for collection and the rest of the blood is returned to the patient.  

 After collection, the T cells are sent for manufacturing. During that time, the patient is given a “bridging therapy” to maintain the myeloma until the CAR T cells are infused.  

Once the CAR T cells are infused, the patient will be closely monitored by the CAR T center. This may or may not include hospitalization depending on the policies of the treatment center. Patients and their care partner should plan to stay close by the center for up to 30 days after the infusion.  

During this time, the patient is evaluated for their response to treatment and monitored for possible side effects so that they can be managed in a timely manner.  

The potential side effects of CAR T-cell therapy may include: 

  • Cytokine release syndrome, or CRS, which is an aggressive response to treatment by the immune system and may cause symptoms such as low blood pressure, high heart rate decreased oxygen saturation, fever, nausea, and body aches. 
  • Another possible side effect is neurotoxicity, which is an adverse event that may cause issues such as confusion, difficulty with communication, seizure, or tremors. 
  • And, another side effect may be low blood counts, which could impact the immune system and increase risk for infection. 

Every patient is different, so close monitoring is essential.  

So now that you know more about CAR T-cell therapy, you can work with your healthcare team to decide if this treatment option may be right for you. Be sure to speak up and ask questions. Remember, you have a voice in YOUR myeloma care. 

To learn more about myeloma and to access tools for self-advocacy, visit powerfulpatients.org/myeloma.  

Understanding Possible Side Effects of CAR T-Cell Therapy

/in , , , , , , , /by

Understanding Possible Side Effects of CAR T-Cell Therapy from Patient Empowerment Network on Vimeo.

What side effects should you be aware of when considering CAR T-cell therapy? Dr. Adriana reviews the issues that may occur after undergoing CAR T-cell therapy and how the side effects are managed.

Dr. Adriana Rossi is co-director of the CAR T and stem cell transplant program at the Center for Excellence for Multiple Myeloma at Mount Sinai Health System in New York City. Learn more about Dr. Rossi.

See More From Thrive CAR T-Cell Therapy

Related Resources:

Monitoring Health After CAR T-Cell Therapy | What to Expect

Monitoring Health After CAR T-Cell Therapy | What to Expect

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

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

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

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

Transcript:

Katherine Banwell:

Of course, we know that CAR T-cell therapy comes with some potential side effects. Let’s talk about some of those side effects and how they’re managed. You mentioned cytokine release syndrome earlier. Let’s start with that. What is it, exactly?  

 Dr. Adriana Rossi:

As I mentioned, cytokines are molecules that the cells of the immune system use to communicate with each other. With this therapy, we are asking the T cells that have been infused to expand, meaning make multiple copies of themselves, and sweep through the body looking for myeloma and basically picking a fight with them.  

So, CRS is what happens when the T cells are too good at their job and they overachieve and then picking a little fight kind of make a big ruckus. The result is what we call inflammation, which the patient will experience usually as a fever.  

But if it does not go – if it continues to go unchecked, that fever can be accompanied by low blood pressure because of these inflammatory markers, difficulty breathing or low oxygen levels. And all of these things are now vastly prevented. CRS is usually treated very quickly and doesn’t get to these higher grades, more complicated fields.  

Katherine Banwell:

How is CRS managed?  

Dr. Adriana Rossi:

We have a couple of very good antidotes. CRS by itself is not just a fever. Certainly, a fever in any patient who is undergoing these kinds of therapies, we will try to rule out any infections. But there are markers in the blood that we can follow. When the blood markers and the fever occur at the same time, we know that cytokines are driving that effect. If it seems to be driven by something we call IL-6, we use tocilizumab (Actemra). If it seems to be driven by IL-1, we use anakinra (Kineret). These are all drugs that are themselves monoclonal antibodies which then will shut down that overreaction and cool things down.  

Katherine Banwell:

Another possible side effect is neurotoxicity. Would you define that term for us?  

Dr. Adriana Rossi:

Yes. That one is harder to define because neurotoxicity in itself is very broad. We usually think of something called ICANS, which is the neurotoxicity associated with the effector cells. That specific neurotoxicity tends to happen in conjunction with CRS.  

And while CRS probably occurs in about 85 percent of patients, the ICANS is usually in the order of 5 percent. So, much, much more rare. And the antidote for that, which most patients know, love, and hate, is steroids.  

Katherine Banwell:

Ah, yes.  

Dr. Adriana Rossi:

I should mention there are other parts of neurotoxicity which I think the most concerning is something that has been known as Parkinsonian symptoms. It’s really just movement disorder. These are exceedingly rare and so we haven’t had a chance to learn very much because there are so few patients who have had this complication. We have learned from the first six patients who had this how to avoid it. And so, I think it’s now even more rare and it really goes into patient selection, to making sure, as I mentioned, that the myeloma isn’t growing very much.  

We monitor to see if the T cells grow too fast, if the CRS is of a high level. These are all predictors of delayed neurotoxicity.  

Katherine Banwell:

What are the signs of neurotoxicity in a patient?  

Dr. Adriana Rossi:

Very specifically, for the ICANS, we have tool called the ICE tool, which is a series of questions to test memory and attention and ability to write and understand and speak. So, most commonly, it would be an inability to speak properly or, if someone is writing a sentence, it’s really a very classic finding. It is no longer spread across the page.  

These are not subtle findings. Part of, again, being in the hospital is to allow us to have this tool twice a day and look for these signs very early on, interfere with their development by giving the patients steroids – usually for a day or two – and resolving it.  

Katherine Banwell:

And is there a potential for long-term issues associated with neurotoxicity?  

Dr. Adriana Rossi:

Certainly, there is always the potential. But the vast majority – again, the ICANS tend to be self-limited while the patient’s in the hospital, and that is why we’re watching during that window. The delayed neurotoxicities, in addition to these very rare movement disorders, we do see some cranial nerve palsies. The seventh cranial nerve, usually recognized as Bell’s palsy, has happened a few times. We really don’t understand the mechanism of what is driving it. It’s inflammation but why there, why that way. So, we tend to use acyclovir, which is the classic treatment for Bell’s palsy and steroids.  

Katherine Banwell:

Dr. Rossi, a suppressed immune system is something that a patient undergoing CAR T-cell therapy should consider. What does it mean, and what precautions should patients take?  

Dr. Adriana Rossi:

That is such a good question, and it is specifically true for patients who are receiving therapies that target BCMA, which both commercial CAR Ts at the moment target.  

Because it is such an effective therapy at bringing down cells that express BCMA, your immune cells that make antibodies, one of the side effects is the immunoglobulins, which are the antibodies, are all very, very low. So, that is one level of immunosuppression.  

The other is the chemotherapy that we use to quiet the T cells can also lower all the blood counts. So, red blood cells and platelets may be low as well and those are not involved with immunity and can be transfused. So, that is a supportive mechanism. For the immune therapies, we usually use IVIG, which is intravenous immunoglobulins to support the patient until they’re able to make their own.  

We also protect them from viral infections with acyclovir or valacyclovir. Protect them from something called PJP pneumonia, which is a virus that specifically appears when you’re very immunosuppressed. Should their neutrophil count be low, that is another type of white blood cell – make sure they’re protected with antibiotics.   

Questions to Ask Your Doctor About CAR T-Cell Therapy

/in , , , , , , , /by

Questions to Ask Your Doctor About CAR T-Cell Therapy from Patient Empowerment Network on Vimeo.

What should you know when considering CAR T-cell therapy for myeloma? This animated explainer video provides an overview of key questions to ask your healthcare team and advice for patients and care partners when considering CAR T-cell therapy.

See More from Evolve Myeloma

Related Resources:

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

 Accessing Myeloma CAR T-Cell Therapy Clinical Trials

Accessing Myeloma CAR T-Cell Therapy Clinical Trials

Transcript:

While receiving a myeloma diagnosis and choosing a therapy can be overwhelming, advancements in research are providing more options and more hope for patients than ever.  

And these advancements include CAR T-cell therapy – a treatment in which a patient’s T cells, a type of immune system cell, are laboratory-altered to attack cancer cells in the body.  

If you are curious about this option, consider asking your healthcare team these key questions: 

  • Am I a candidate? 

CAR T-cell therapy patients must meet specific criteria. 

  • What are the risks? Common side effects of this type of therapy are cytokine release syndrome (CRS), neurotoxicity, suppressed immune system, and low blood counts. 
  • Is the timing right for me? The current approval is for patients who are later in their myeloma journey. 
  • Are there alternatives? Ask about other treatment options that may be appropriate for your myeloma. 
  • Is there a clinical trial that may be right for me? There are many myeloma treatments available in clinical trials, there may even be CAR T-cell therapy options. 
  • What is the cost? Every person’s insurance situation is different so it’s important to understand what the financial impact will be. 
  • What is the center’s experience with CAR T-cell therapy? Your healthcare team should be well-versed in this type of treatment. 

Beyond asking these questions, it’s also critical to research the therapy on your own –– ask your doctor where to find reliable information about the options you are considering.   

You should also discuss the pros and cons of each treatment option with your healthcare team, inquiring about potential side effects, and understand how the treatment is administered and the frequency of appointments. 

And it’s always a good idea to review your treatment choices with a care partner, such as a friend or loved one – someone you trust. 

Finally, always speak up and ask questions. Remember, you have a voice in YOUR myeloma care. 

To learn more about myeloma and to access tools for self-advocacy, visit powerfulpatients.org/myeloma.  

Updates in AML Treatment and Research From ASCO 2023

/in , , , , , , , /by

Updates in AML Treatment and Research From ASCO 2023 from Patient Empowerment Network on Vimeo.

AML expert Dr. Omer Jamy shares highlights from the recent American Society of Clinical Oncology (ASCO) annual meeting, including an update on an immunotherapy agent showing promise as well as a vaccine therapy being studied for patients in a second remission.

Dr. Omer Jamy is a Leukemia and Bone Marrow Transplant Physician and Assistant Professor at the University of Alabama at Birmingham. Learn more about Dr. Omer Jamy.

See More from Thrive AML

Related Resources:

Expert Perspective | Key Advice for AML Patients

Expert Perspective | Key Advice for AML Patients

What Are the Phases of AML Therapy

Transcript:

Dr. Omer Jamy:

My name is Omer Jamy, and I’m a leukemia and bone marrow transplant physician at the University of Alabama at Birmingham. And I’m really happy to be here today.  

Katherine Banwell:

Well, thank you. Dr. Jamy, the ASCO 2023 meeting just wrapped up recently. What were the highlights in AML research from that meeting? 

Dr. Omer Jamy:

Thank you. Yeah. There were several interesting studies in AML presented at ASCO this year. I’d like to highlight a couple of them in particular mainly because the focus on a novel mechanism of action, at least for patients with acute myeloid leukemia. And that mechanism of action being immunotherapy. So, we’re all aware that immunotherapy has had tremendous results in solid tumors.   

It’s making its way into hematological malignancies mainly lymphomas as well as B-cell ALL which is acute lymphoblastic leukemia. And we are trying to investigate it in patients with AML as well.  

And I think in that context there were a couple of abstracts which I thought were really interesting. The first one was actually presented by Dr. Anthony Stein and colleagues. Looking at a drug which is basically CD123 NK-cell engager.  

And I spent a little bit trying to explain what that is, but basically, it’s a drug which it harnesses the person’s immune system to fight the cancer basically. So, it targets an antigen which is expressed on leukemia cells called CD123. And it binds it to natural killer cells or NK cells. So, this drug is taking the host which is the patient’s natural killer cells and the leukemia cells and binding them together and then leads to the activation of the NK cells which causes killing of the leukemia cells.  

So, I think that mechanistically speaking that’s a very interesting concept to fine tune the person’s own immune system to fight the leukemia. This is obviously very early in development, so it’s a Phase I study, Phase I/Phase II. And they have presented results in 23 patients with relapsed/refractory AML.  

And just to give you some background, CD123 is expressed in the majority of patients with acute myeloid leukemia. It’s also expressed in patients with myelodysplastic syndrome as well as ALL. So, the study had all three diseases, but we’re going to focus on AML today. So, there were 23 patients with acute myeloid leukemia in the study. And because it’s a Phase I study, they have to test it at the lowest dose, and then assess for safety, and then keep on going up on the dose. So, they actually looked at six dose levels. And luckily because it’s a Phase I, the primary objective is to make sure it’s a safe drug to administer.  

And then second your objectives are basically if it’s efficacious or not. So, there were no dose limiting toxicities in the 21 evaluable patients out of the 23. So, that’s good. I think the lowest dose was 100 micrograms per kilograms per day. And the highest dose was 3,000 micrograms per kilogram per dose. The doses IV once or twice a week for the first couple of weeks, and then followed by weekly administration. In 23 patients the drug was thought to be safe. Again, no dose limiting toxicities.  

With immunotherapy you worry about side effects such as cytokine release syndrome because you are basically putting your immune system in overdrive. So, you don’t want to make sure your immune system doesn’t wreak havoc on the body itself. So, cytokine release syndrome or CRS as well as associated neurotoxicity are two common side effects of most of these novel immunotherapies.  

Which for the general audience, if they’ve heard about CAR T therapy or antibody drug conjugates or bispecifics, these are all under the same umbrella of immunotherapy. So, their side effect profile is pretty overlapping and different from what would be seen with conventional chemotherapy. So, they saw no neurotoxicity. And they saw CRS which was very manageable, right? Grade 1 or Grade 2 in a couple of patients. And as far as efficacy was concerned, out of the 23 patients they saw a response in three patients. Now that doesn’t sound very appealing, but you have to realize these are starting at a very low dose level and going up. So, when they looked at patients who were getting a dose of 1f,000 micrograms per kilograms per day, so a pretty hefty dose. Three out of eight patients, which roughly translates to 40% of the patients, achieved a remission. So, which to me for relapse refractory population is attractive. And it makes me want to investigate this molecule further.  

And that is exactly what’s going on currently with the study. And I think again CD123 is an interesting target. The other companies targeting as well either as NK-cell engagers or antibody drug conjugates with other payloads. So, this is an area of active investigation. So, that’s where – 

Katherine Banwell:

You said – 

Dr. Omer Jamy:

Yeah.  

Katherine Banwell:

Yeah, you said there was another study. Could you briefly tell us about that.  

Dr. Omer Jamy:

Exactly. So, the other study is also harnessing the person’s immune system to fight leukemia in a very different way. And this is a randomized Phase III study, ongoing. It’s international. And it’s a trials in progress meaning that it’s accruing across the country, or actually across the globe. And I wanted to highlight this in case people want to reach out to centers where this study is ongoing and want to participate in it. This is a trials in progress poster of a compound called GPS which is basically a vaccine against a protein called Wilm’s tumor 1 or WT1 which is vitally expressed on leukemia cells as well.  

Now this is a tumor vaccine actually which is a novel concept of an AML. So, vaccines as you know, are better at prevention than treatment. So, this is a maintenance drug for people in second remission or beyond who are unable to proceed to stem cell transplantation.  

So, they get the opportunity to enroll in this Phase III which is a randomized study of either GPS versus a physician’s choice which includes a wide variety of agents to choose from making it a pretty reasonable control arm and follows patients to see if the primary end point being overall survival. So, I think again for patients who achieve second remission or beyond ideally, they should proceed to stem cell transplantation. But there are several barriers to that including advanced age, comorbidities, socioeconomic barriers. So not everyone can proceed. So, for patients in that situation, there is no standardized maintenance therapy.   

And in that context I feel like an immunotherapy agent basically this vaccine which has shown very promising results in single-arm Phase I, Phase II studies is now being investigated in a Phase III study. And because it’s a trials in progress I cannot share any results with you because we don’t have any results. But I feel like people should know about this because it is open at 20 to 30 centers in the US.  

And it’s an option out there for patients who would like to participate in such a clinical trial. 

What Is CAR T-Cell Therapy for Myeloma?

/in , , , , , , , /by

What Is CAR T-Cell Therapy for Myeloma? from Patient Empowerment Network on Vimeo.

How does CAR T-cell therapy work to treat myeloma? This animated video provides an overview of the CAR T-cell process, explains which patient this treatment could be appropriate for, and reviews potential side effects.

See More From Innovative Myeloma Therapies

Related Programs:

What Is Myeloma CAR T-Cell Therapy?

 How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape?

How Is CAR T-Cell Therapy Changing the Myeloma Treatment Landscape?

 What Are the Risks of CAR T-Cell Therapy?

Transcript:

CAR T-cell therapy is a type of treatment in which a patient’s own immune system cells, also known as T cells, are reprogrammed in a laboratory to attack cancer cells.  

The process involves removing T cells from the patient’s blood. Then, the T cells are sent to a laboratory where a gene for a special receptor that binds to a protein on the patient’s cancer cells is added to the T cells. The special receptor is called a chimeric antigen receptor.  

When this process is complete, the cells are put back into the patient’s body by infusion. The altered T cells then attack and destroy cancer cells in the patient’s body. 

In myeloma patients, the FDA-approved CAR T-cell therapies recognize a protein called B.C.M.A. on the surface of myeloma cells. 

Now that you know how CAR T-cell therapy works, who is CAR T-cell therapy right for? 

  • While still a new treatment, CAR T-cell therapy is currently approved for people with relapsed or refractory multiple myeloma who have already received four or more lines of therapy. 

While every patient reacts differently to CAR T-cell therapy, some of the potential side effects may include: 

  •  Cytokine Release Syndrome, which occurs when the immune system responds to infection or immunotherapy drugs more aggressively than it should. Symptoms may include fever, nausea, fatigue, and body aches.
  • Another potential side effect is neurotoxicity, which may cause negative effects on the nervous system such as confusion, difficulty speaking or understanding, loss of balance or consciousness, tremors and seizures. 
  • And blood count recovery can be slower following CAR T-cell therapy.   

So, what should you ask your doctor about CAR T-cell therapy? 

  • Is CAR T-cell therapy available at this cancer center? 
  • Is CAR T-cell therapy an option for me now or in the future? 
  • What is the cost of this therapy? 
  • What are the risks and benefits of this approach? 
  • What can I expect during the recovery process? 

To learn more about innovative myeloma therapies and to access tools to help you become a pro-active patient, visit powerfulpatients.org.  

Immunotherapy: Which Myeloma Patients Is It Right For?

/in , , , , , , /by

Immunotherapy: Which Myeloma Patients Is It Right For? from Patient Empowerment Network on Vimeo.

Dr. Krina Patel, a myeloma specialist and researcher, explains how newer therapies, such as CAR T-cell therapy, are being used in myeloma and which patients these treatments are most appropriate for.

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, here.

Related Resources:

How Does Immunotherapy Treat Myeloma?

 What Are the Side Effects of Myeloma Immunotherapy?

 Myeloma Treatment & Research Updates From 2022 ASCO and EHA Meetings

Transcript:

Katherine:   

Now, in reference to immunotherapy and CAR T-cell therapy, who are these types of treatments right for?

Dr. Patel:    

So, I think it’s really exciting that we finally are getting standard of care therapies for all these new immune therapies. So, our first CAR T for myeloma got approved a little over a year ago. Our second CAR T got approved just a couple of months ago, and we’re hoping our first bispecific will be approved in just a couple months.

Our fingers crossed. On the clinical trials, I will say our patients who had a good performance status, meaning they’re able to do everything else normally life-wise, those are the patients that got onto those clinical trials; and the reason is safety-wise.

So, T cells when we use them to kill myeloma, they release cytokines or enzymes, you can say, that are inside the T cells and that’s what they use to communicate with other immune cells to come help them kill.

Those are the same cytokines that make people feel really ill when they have the flu, for instance. So, as our immune system tries to fight infections when people get fevers, they feel chills, they feel just fatigued and tired, it’s those same kind of cytokines that, even when you try to kill the myeloma with T cells, people can get that same type of symptoms.

And really, the main, fevers and things like that, we can take care of. But when patients’ blood pressure drops or if their oxygen levels drop really low, that’s where we can run into some trouble. Now, the good news is, in myeloma, most of these new therapies don’t cause really bad CRS [Cytokine Release Syndrome] or really bad neurotoxicity that we can sometimes see. And so, thankfully most patients are okay, but really it’s making sure that none of our patients have bad toxicity. So, most of our myeloma patients, I will say, are eligible for these therapies. However, if someone has really bad heart disease or really bad lung disease, those are patients that maybe these are not the right therapies for.