NCT06793449

BCMA CAR-T Versus ASCT in Transplant-eligible Patients With Multiple Myeloma

A Prospective, Non-inferiority Study Comparing VRD±D Followed by BCMA CAR-T Cell Therapy Versus VRD±D Followed by Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly-diagnosed Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-inferiority study comparing VRD±D followed by BCMA CAR-T cell therapy versus VRD±D followed by autologous hematopoietic stem cell transplantation in the treatment of newly diagnosed multiple myeloma patients.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	anti-BCMA CAR-T	Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg.
BIOLOGICAL	ASCT	Autologous stem cell infusion

Timeline

• Start date: 2025-02-05
• Primary completion: 2026-12-01
• Completion: 2030-12-01
• First posted: 2025-01-27
• Last updated: 2025-08-03

Locations

1 site across 1 country: China