A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Subjects with Relapsed or Refractory and lenalidomide-refractory Multiple Myeloma
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Jun 2032
In plain English
AI plain-English summary
A new CAR-T cell therapy, BMS-986393, is being tested head-to-head against standard treatments in adults with multiple myeloma that has stopped responding to the drug lenalidomide. This matters because multiple myeloma is incurable, and each relapse makes the disease harder to treat. When patients become refractory to lenalidomide—a common backbone therapy—their survival odds drop sharply, and few effective options remain. BMS-986393 works by reprogramming a patient’s own immune T-cells to recognise and attack myeloma cells via a surface protein called GPRC5D, offering a fundamentally different attack route than existing drugs. If this phase 3 trial shows that BMS-986393 delays relapse or improves survival better than the current standard regimens (daratumumab-pomalidomide-dexamethasone or carfilzomib-dexamethasone), it could become a new treatment option for a patient group with very limited choices. The study will enrol adults across multiple centres, randomly assigning them to receive either the CAR-T therapy or a standard regimen, with regular monitoring over roughly 89 months. Success would mean a targeted, cell-based therapy enters routine care for lenalidomide-refractory myeloma.
View original technical description
Multiple myeloma is a type of blood cancer that affects cells in your bones called plasma cells. These cells help your body fight infections. Even with new treatments, multiple myeloma cannot be cured, and the disease often comes back, which is called a relapse. At each relapse, it gets harder to treat and some treatments stop working, which is called being refractory. When patients become refractory to a drug called lenalidomide, their chances of survival go down, so new treatments are needed. One new treatment, called BMS-986393, is a (CAR) T-cell therapy. It uses the patient's own immune cells (T-cells), which are modified to find and attack multiple myeloma cells by targeting a protein on their surface called GPRC5D. Results from another study of BMS-986393 show the drug seems to work and has side effects that doctors can manage.This new study aims to see if BMS-986393 works better than two other common treatments, DPd [daratumumab, pomalidomide, dexamethasone] or Kd [carfilzomib, dexamethasone], in adults with multiple myeloma that has come back or stopped responding to lenalidomide. Participants will be randomly assigned (like flipping a coin) to receive either BMS-986393 (study arm A) or one of the other treatments, DPd or Kd (study arm B). Participants in arm A will have T-cells taken from their blood and receive chemotherapy before receiving BMS-986393. Participants in arm B will receive either DPd or Kd as their treatment. After treatment, all participants will be checked regularly. Study tests will include physical and neurological exams, heart and body scans, bone marrow tests/biopsies, ECG, vital signs (blood pressure, heart rate, temperature and oxygen levels), height and weight measurements, blood and urine tests and health-related questionnaires. The study is expected to last about 89 months.
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