The goal of this clinical trial is to compare the efficacy of treatment with BMS-986393 to treatment with standard of care therapies in patients with relapsed/refractory multiple myeloma.
This trial is currently open and accepting patients.
This trial is seeking approximately 440 participants. Participants will be randomized into one of two groups (or arms). Participants in Arm A will receive treatment with a GPRC5D Car T-Cell therapy, BMS-986393. Participants in Arm B will receive one of two standard of care regimens, Daratumumab + Pomalidomide + Dexamethasone or Carfilzomib + Dexamethasone. This trial is open-label, which means that both researchers and participants will know which arms they are placed in, and which therapies they will be receiving.
Participants will start the process of receiving BMS-986393 by undergoing a process called leukapheresis. This means that T cells will be removed from their blood and changed in a laboratory to become the investigational CAR T-cell therapy, BMS-986393. During the time that BMS-986393 is being manufactured, participants will receive mandatory bridging therapy with either Daratumumab, Pomalidomide and Dexamethasone or Carfilzomib and Dexamethasone.
Participants may be hospitalized while receiving BMS-986393 or may receive investigational BMS-986393 at a qualified outpatient center depending on the investigators discretion. Participants will need to be closely monitored after receiving investigational BMS-986393. Patients will need to stay within a 30-minute transportation ride to the study site for at least 7 days and then within 120-minute transportation ride to the site and have a dedicated full-time caregiver or caregivers until 1 month after the investigational BMS-986393 infusion.
Daratumumab + Pomalidomide + Dexamethasone OR Carfilzomib + Dexamethasone
This arm is organized into 28 day cycles. Participants in this arm will receive one of two different combinations. Study participants in this arm may continue to receive study medications unless their myeloma gets worse, or they experience serious side effects.
Daratumumab, Pomalidomide and Dexamethasone
Participants in this group will receive:
Daratumumab by subcutaneous injection weekly during cycles 1-2, every other week during cycles 3-6, and monthly from cycle 7 onwards,
Pomalidomide by mouth every day, and
Dexamethasone by mouth or intravenous injection weekly.
Carfilzomib and Dexamethasone
Participants in this group will receive:
Carfilzomib by intravenous injection either once or twice weekly during the first three or four weeks of each cycle.
Dexamethasone by mouth or intravenous injection weekly.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Phase 3
Enrollment: 440 patients (estimated)
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Birmingham, AL
Miami, FL
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