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NOT YET RECRUITING
NCT06963866
PHASE2

Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT

Sponsor: Xuzhou Medical University

View on ClinicalTrials.gov

Summary

This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.

Official title: A Multicenter, Open-Label, Randomized, Controlled Study of Autologous Stem Cell Transplantation Followed by Anti-BCMA CAR-T Therapy Versus ASCT Alone in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05-01

Completion Date

2028-04-30

Last Updated

2025-05-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

autologous stem cell transplantation

Patients in this arm will receive autologous hematopoietic stem cell transplantation (ASCT). Prior to ASCT, the patients underwent 3-4 cycles of induction chemotherapy.

BIOLOGICAL

CAR-T

The T cells are genetically modified to express a chimeric antigen receptor targeting BCMA and are infused 3 days after ASCT at a target dose of ≥2.0×10\^6 cells/kg.

Locations (1)

The Affiliated Hospital oh Xuzhou Medical University

Xuzhou, Jiangsu, China