A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)

Multiple myeloma (MM) is a cancer of plasma cells, which are found in bones and help fight infections. Even with new treatments, MM cannot be cured, and most patients will eventually have a return of the disease (relapse). Each relapse makes the outlook worse, and patients may stop responding to certain treatments (refractory). When patients become refractory to a drug called lenalidomide (LEN), their chances of survival go down, hence new treatments are urgently needed. 

Arlocabtagene autoleucel (BMS-986393) or arlo-cel is a treatment called chimeric antigen receptor (CAR) T-cell therapy. It uses the patient's own immune cells, which are modified to find and attack MM cells by targeting a specific protein on their surface called GPRC5D. Results from another clinical trial of arlo-cel are promising, showing that arlo-cel seems to work and has side effects that are manageable by the health care provider. This study aims to see if arlo-cel is safe and more effective compared to two common standard treatments, DPd [daratumumab, pomalidomide, dexamethasone] or Kd [carfilzomib, dexamethasone], in patients with relapsed or refractory MM (RRMM) and exposed to LEN.