While chimeric antigen receptor (CAR) T–cell therapy has revolutionized the treatment landscape for multiple myeloma, the high demand for these efficacious therapies has made patient selection a challenge. At the recent International Myeloma Society Annual Meeting, Beth Faiman, a Nurse Practitioner at the Cleveland Clinic, presented a poster about a clinical factor scoring system that she and her colleagues have developed to aid in these decisions. In this follow-up interview with Oncology Data Advisor, Dr. Faiman explains how this innovative system works and the next steps to validate it and implement it into practice in the future.
Oncology Data Advisor: Hi, and welcome to Oncology Data Advisor. Today I'm speaking with Beth Faiman about her recent presentation at the International Myeloma Society Annual Meeting. Dr. Faiman, thank you so much for being here with us today.
Beth Faiman, PhD, CNP: Hello, my name is Beth Faiman. I am a Nurse Practitioner and a researcher at the Cleveland Clinic in Cleveland, Ohio. I've been at the Cleveland Clinic since 1994, and I've been fortunate to be working with plasma cell and blood disorders ever since then. Currently, I am working on a scoring system for cellular therapy candidates, and I think that's what we're going to be talking about today.
Oncology Data Advisor: Yes, I'm excited to hear more about your presentation. Just by way of background, what are some of the challenges that are involved when selecting patients for treatment with CAR T-cell therapy?
Dr. Faiman: Right, so CAR T-cell therapy has been FDA-approved in the United States for multiple myeloma in patients with relapsed and refractory status since 2021. There are now two products approved. There is idecabtagene vicleucel (Abecma®) from 2021 and ciltacabtagene autoleucel (CarvyktiTM) in 2022. These are valuable therapies for the patients who oftentimes have limited options, but unfortunately, there's a lack of supply right now. They're in such high demand, and it's really hard to get on the list and be selected for one of these therapies when few options are available.
Oncology Data Advisor: Tell me a little about your study; how did you go about developing this scoring system?
Dr. Faiman: I work in a large group practice at the Cleveland Clinic. I have numerous researchers that I partner with, and we have these meetings that are convened on a weekly basis. It's composed of physicians, nurses, nurse practitioners, and other support staff. In these meetings on a weekly basis, we're trying to determine who would be the best next candidate when you have one slot or two slots from that company, and a list of 40, 50, or sometimes 80 patients who would be candidates.
We had these early discussions and they said, "You know, it would be really great to be able to categorize or rank order to determine the best way of selecting, so those patients don't miss out on the opportunity, the ones that really need it." We developed this six-criteria scoring system, and we developed a maximum criteria number of 18. Those that qualify have the worst disease, what we call penta-refractory disease, or they've had a recent aggressive relapse with lots of tumors. Maybe they're requiring bridge therapy with some very sophisticated inpatient chemotherapy. Others are not in remission, but we do want them, over and above anything else, to be clinically stable in order to harvest these cells and send them off for manufacturing. Then they come back to the patient four to eight weeks later.
Again, through discussions with the clinical team, we've devised this system through expert opinion and literature review. There's really nothing like this out there at any of the large myeloma institutions in the country, from what I understand.
Oncology Data Advisor: That's really exciting. What are the criteria and the factors that this scoring system involves?
Dr. Faiman: Just as I previously mentioned, we're really looking at those who don't have any other options. When people are considered penta-refractory—and these are the ones who are the best candidates—they have failed a drug called an anti-CD38 monoclonal antibody. They've also failed proteasome inhibitors and immunomodulatory drugs, the backbones of our treatment. Also, they've had exportin 1 (XPO1) inhibitors such as selinexor or other B-cell maturation antigen (BCMA) therapies off the shelf, such as belantamab mafodotin. Those are the five drug classes that all of our patients will oftentimes be exposed to.
We also want them to be fit enough so that they can tolerate this therapy. There is a long process in this selection of patients. Of course, according to the FDA guidance, they have to be willing and capable and able to have support systems such as caregivers support, as well.
Oncology Data Advisor: Great. Now that this has been developed, what are the next steps for it, and how can it be implemented into practice in the future?
Dr. Faiman: Unfortunately, we are still in our infancy. The tool development is a lengthy process, and I'm trying to work with my researcher colleagues to expedite this. Others have reached out to me to validate this tool, and when you're developing a clinical tool, you want it to be reproducible. You want to make sure that whoever implements or uses this tool in their practice will have similar results to the Cleveland Clinic at their institutions. There's a validity and reliability of this tool that still needs to be investigated. We need to try this out on more patients, and we are continuing to do so.
My abstract only reported data from February to May of 2022, but we're continuing to score our patients on a weekly basis at Cleveland Clinic. Hopefully, we'll be able to open up this tool for use in other institutions as well, so that we can make this generalizable and so that others can benefit from it as well.
Oncology Data Advisor: That's great. Is there anything else you'd like to share about this research?
Oncology Data Advisor: Oh, I'm extremely humbled by the amount of interest in a tool such as this. There is a lack of validated clinical factors when you're selecting these patients, and we all have this shared common goal of balancing the quality of life and quantity of life in our patients with myeloma. We're really just trying to develop an innovative scoring system that addresses this clinical need when we have a lack of spots available for this potentially life-saving therapy.
We're not trying to cure everybody, and we can't at this stage. But hopefully we'll be able to continue to evolve this tool so that we can move it earlier on in patient selection. We're not waiting for the sickest of the sick, which we might be forced to do in the next two years or so. We'll be able to open it up to more patients so that everybody can benefit from this CAR T-cell therapy treatment.
Oncology Data Advisor: Definitely. That'll be very exciting to see how it continues to evolve in the future.
Dr. Faiman: Thank you. I hope so.
Oncology Data Advisor: Yes, so thank you so much for sharing all this with us. It was really great to learn.
Dr. Faiman: Oh, my pleasure. Thank you for this opportunity, I really appreciate it.
About Dr. Faiman
Beth Faiman, PhD, CNP, is a Nurse Practitioner in the Department of Hematologic Oncology and Blood Disorders at the Cleveland Clinic, where she specializes in the treatment of multiple myeloma, amyloidosis, chronic lymphocytic leukemia, and plasma cell cancers. Dr. Faiman has been instrumental in the development of nursing management guidelines for multiple myeloma and is an internationally renowned expert in oncology nursing. She has won several awards, including the Leukemia & Lymphoma Society's Woman of the Year Award in 2016.
For More Information
Faiman B, Valent J, Khouri J, et al (2022). Proposed clinical factors scoring system for chimeric antigen receptor T-cell (CAR T) patient selection in relapsed and refractory multiple myeloma (RRMM). International Myeloma Society 19th Annual Meeting and Exposition. Abstract P-007.
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.
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