Evaluate and compare the safety and efficacy of BCMA-CART ± ASCT in the treatment of newly diagnosed multiple myeloma (NDMM) in young patients
This study is a single-center, open-label, prospective investigator-initiated clinical study. Patients are assigned to treatment groups in a non-randomized manner based on their condition and disease status, and are divided into transplant and non-transplant groups according to whether ASCT is combined. The study analyzes and compares the safety and efficacy of BCMA-CART ± ASCT treatment in young MM patients.
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
RECRUITINGAssessment and comparison of MRD negativity rate 3 months after BCMA-CART±ASCT
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
PK:Cmax,Tmax,AUC(0-28days),Tlast
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flow cytometry and qPCR
Time frame: 2 years