To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of young NDMM
This study is a single center, prospective clinical study initiated by researchers to evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation combined with BCMA-CART cells in the treatment of young patients with newly diagnosed multiple myeloma, aiming to explore the safety and efficacy of ASCT combined with BCMA-CART in the treatment of young patients with NDMM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Chimeric antigen receptor T cells (car-t) are genetically engineered MHC independent tumor specific killer cells.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGMRD negative rate at 3 month after the treatment of autologous transplantation combined with CART.
MRD by flow cytometry
Time frame: 3 month
Progression-free Survival (PFS)
Time from CAR-T infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Time frame: 2 years after CAR-T infusion
Minimal Residual Disease (MRD) negetive rate
Proportion of subjects who achieved MRD negative
Time frame: at day28, M2, M3, M6, M9, M12, M15, M18, M24 after CAR-T infusion
Overall response rate (ORR) evaluated by the investigators
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigators
Time frame: 2 years after CAR-T infusion
Duration of Response (DOR)
Time from first response evaluated by an investigators to disease progression or death from any cause
Time frame: 2 years after CAR-T infusion
Time to Response (TTR)
Time from CAR-T infusion to first documentation of response evaluated by an investigator
Time frame: 2 years after CAR-T infusion
Overall Survival (OS)
Time from CAR-T infusion to time of death due to any cause
Time frame: 2 years after CAR-T infusion
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PK:Cmax,Tmax,AUC(0-28days),Tlast
flow cytometry and qPCR
Time frame: 2 years