On April 5, 2024, the FDA revised the indications of both approved CAR T cell therapies for relapsed multiple myeloma to allow the use of these therapies earlier in the course of the disease.

CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) is now FDA-approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide and ABECMA®  (idecabtagene vicleucel;ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor,  an immunomodulatory agent and an anti-CD38 monoclonal antibody. This is welcoming news for patients with multiple myeloma.

Among patients with multiple myeloma, a cancer of the bone marrow plasma cells, these immunotherapies harness the patient’s own modified T-cells to find and destroy the cancer cells, including a high number of patients achieving a complete response.

It is estimated that 35,000 or more new cases of multiple myeloma will be diagnosed this year in the U.S. Currently, this disease is not curable, and patients will undergo multiple lines of treatments. Previously, CARVYKTI and ABECMA were only allowed for patients who had failed at least four lines of therapy. With these FDA approvals, more patients will be able to access this innovative treatment early.

Historical Use of CAR T Therapy for Multiple Myeloma

The first approved CAR T treatment for multiple myeloma was idecabtagene vicleucel, or idel-cel, sold under the brand name Abecma. It was approved in March 2021 for individuals with multiple myeloma cancer who either haven’t responded to or have returned after at least four different prior cancer treatments based on the KarMMA trial which demonstrated overall and complete response rates of 73% and 33%. We recently reported real-world experience with ide-cel in a population like the KarMMA trial and confirmed the efficacy of ide-cel in the real world with overall and complete remission rates of 86% and 42%, respectively.

In February 2022, the FDA approved ciltacabtagene autoleucel, also known as cilta-cel and sold under the brand name Carvykti, for patients not responding to other treatments or those whose cancer has relapsed after 4 prior lines of therapy, based on the Cartitude 1 study in which showed responses in 98% of participants, with 78% seeing a complete response.

These therapies provide the patients high disease control and a significant amount of time when no treatment must be administered, therefore having a very significant impact on quality of life.

This is a significant difference between these CAR T-cell therapies and standard multiple myeloma treatments, which often require continuous treatment until toxicity or progression.

Multiple Myeloma Clinical Trials

While there are only two FDA-approved CAR T-cell therapies to treat multiple myeloma, Moffitt is dedicated to studying novel and innovative treatments through several clinical trials for patients with multiple myeloma, including a novel CAR T therapy ddBCMA and the use of CAR T in patients with newly diagnosed myeloma.

Moffitt is the Place to Be for Multiple Myeloma Treatment

Moffitt is one of the best places for patients to receive state-of-the-art multiple myeloma treatment. It is the largest multiple myeloma program in Florida, highly regarded for its expertise in treating this hematologic malignancy.

In 2021, soon after the first CAR T-cell therapy was approved for multiple myeloma, Moffitt’s Dr. Doris Hansen, assistant member in the Department of Blood and Marrow Transplant and Cellular Immunotherapy, established an alliance of fifteen CAR T-cell therapy programs nationwide. This Multiple Myeloma Cellular Therapy Consortium is dedicated to sharing data between institutions to expedite scientific breakthroughs that can improve patient outcomes. It is the largest cohort of multiple myeloma patients treated with this innovative cell therapy and has produced the first multi-center data for standard-of-care outcomes.

If your patient has been diagnosed with multiple myeloma, quick action is critical. Upon referring your patient to Moffitt Cancer Center, we provide first-rate diagnostics and follow-up with personalized treatment plans developed by our multispecialty team of experts based on the most up-to-date data. Our myeloma physicians work closely with community oncologists to provide the best possible care for your patients.

In addition to CAR T therapy, other multiple myeloma treatment options can include bone marrow transplants, radiation and chemotherapy. Moffitt may also utilize EMMA, an ex vivo mathematical myeloma advisor, a tool developed by Dr. Ken Shain research laboratory, that provides personalized treatment recommendations by testing a patient’s myeloma cells' sensitivity to several drugs at once, both individually and in combination. EMMA aims to eliminate a trial-and-error methodology through this personalized medicine tool that can create the ideal course of treatment for each unique patient.

Moffitt is one of the highest-volume providers of CAR T-cell therapy globally, having treated more than 300 multiple myeloma patients with FDA-approved therapies. Data shows that multiple myeloma patients with treatment plans developed by high-volume cancer centers such as Moffitt experience improved outcomes, including increased overall survival rates.

The FDA approval for ide-cel and cilta-cel for use in the earlier treatment of multiple myeloma marks a new milestone in the treatment of myeloma patients nationwide and Moffitt is poised to immediately provide these innovative therapies as a second- or third-line treatment, giving patients the best chance for successful results.

If you’d like to refer a multiple myeloma patient to Moffitt for treatment, complete our online form contact a physician liaison, or reach out directly to one of our myeloma providers for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.