Phase III Study Comparing Equecabtagene Autoleucel Injection to Standard Therapy in Adults With Lenalidomide-Refractory Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the efficacy of Equecabtagene Autoleucel Injection compared to standard therapy in adults with lenalidomide-refractory relapsed or refractory multiple myeloma RRMM who have received one to two prior treatments. This phase III, multicenter, randomized, controlled, open-label study focuses on patients whose disease has progressed despite previous therapies, aiming to better understand treatment options in this condition over about six years. Participants will be assigned randomly to receive either the experimental treatment, Equecabtagene Autoleucel a CAR-T cell therapy targeting BCMA, given as a single injection dose, or standard therapies including combinations of Daratumumab, Bortezomib, Dexamethasone, and Pomalidomide in various regimens. The study involves an initial screening phase followed by treatment and a follow-up phase to monitor safety, treatment effects, and pharmacokinetics. During the study, participants will undergo regular assessments such as laboratory tests, response evaluations, and safety monitoring for up to five years from randomization. Researchers will measure outcomes including progression-free survival, response rates, minimal residual disease negativity, overall survival, and quality of life. The study includes pharmacokinetic and pharmacodynamic monitoring to understand how the experimental treatment behaves in the body.

A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)