Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
This is a prospectiv , single arm, open-label, single-center study. This study is indicated for refractory and relapsed multiple myeloma. It aims to evaluate the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T to treat refractory and relapsed multiple myeloma. The main research is completely alleviated, overall reaction rate, and recurrence rate,etc. 50 patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: 24 months after cell infusion
overall response rate
The number of response patients/the number of total patients
Time frame: Up to 30 months
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Time frame: Baseline up to 2 years after BCMA CAR T-cells infusion
Overall survival (OS)
Assessment of OS at Month 6,12,18and 24
Time frame: Month 6,12,18and 24
Duration of response(DOR)
Assessment of OS at Month 6,12,18and 24
Time frame: Month 6,12,18and 24
Progression-free survival (PFS)
Assessment of PFS at Month 6,12,18and 24
Time frame: Month 6,12,18and 24
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