Study of Autologous Stem Cell Transplantation with BCMA CAR-T Therapy for Adults 18 to 70 Years with Ultra High Risk Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining autologous hematopoietic stem cell transplantation ASCT with BCMA CAR-T cell therapy to treat patients with ultra-high risk multiple myeloma UHR-MM. This prospective, single-center clinical study focuses on patients aged 18 to 70 years who meet specific high-risk criteria related to their multiple myeloma condition. The study is designed to explore how this combination treatment works in this challenging patient group. Participants receive autologous hematopoietic stem cell transplantation followed by reinfusion of BCMA-CAR-T cells at a dose of 1.0 to 2.0 million CAR-T cells per kg body weight, administered around day 3 after stem cell infusion. This approach is being studied to understand the combined impact of these treatments. The study includes closely monitored treatment and follow-up periods to assess patient responses and safety. During the study, participants will undergo evaluations including blood tests, organ function assessments, and disease monitoring to track treatment effects and safety. The primary outcome measure is the rate of minimal residual disease MRD negativity three months after treatment. Participants will be followed for safety and efficacy outcomes, with careful monitoring throughout the trial duration. The total participation time depends on the study timeline, which extends through several months after treatment.

Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM