Efficacy of Sequential BCMA CAR-T Cell Therapy Following Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2028

Conditions
Multiple Myeloma
Interventions
BIOLOGICAL

CAR-T

All enrolled patients will receive three cycles of induction therapy using either the DVRd regimen (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone) or the DKRd regimen (Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone). Following induction, patients will undergo high-dose melphalan conditioning followed by autologous hematopoietic stem cell transplantation. On Day 5 after stem cell reinfusion, patients will receive anti-BCMA CAR-T cell infusion. After CAR-T therapy, patients will enter the maintenance phase with lenalidomide monotherapy or lenalidomide in combination with bortezomib until disease progression or intolerable toxicity occurs.

All Listed Sponsors
lead

Xuzhou Medical University

OTHER