The purpose of this study is to evaluate the safety and efficacy of BiRd regimen combined with BCMA CAR T cell therapy in newly diagnosed multiple myeloma patients
This is a phase 3, single arm, multi-center study. The patients will receive BiRd regimen (clarithromycin,lenalidomide, dexamethasone) combined with infusion of autologous BCMA-directed CAR T-cells in newly diagnosed MM patients. The study participation will be 4 years including treatment and follow-up periods.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
* clarithromycin: 500mg, PO, twice daily, on days 1\~21 for a 28-day cycle. * lenalidomide: 25mg, PO, on days 1\~21 for a 28-day cycle. dexamethasone: 40mg, PO on days 1,8,15 and 22 for a 28-day cycle. BCMA CAR T cell: (2-3)×10E7/kg, intravenously infusion. * Doses should be adjusted according to renal function.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall response rate (ORR)
ORR includes stringent complete response (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR). Stringent complete response (sCR): complete response as defined below plus normal free light chain (FLC) and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ patients, respectively, after counting ≥100 plasma cells). Complete Response (CR)：negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Very good partial response (VGPR)：serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 h. Partial response (PR): ≥50% reduction of serum M-protein plus reduction in 24 h urine M-protein by ≥90% or to \<200 mg per 24 h.
Time frame: 4 weeks after CAR T-cells infusion (up to 14 weeks)
Overall survival (OS)
time from enrollment to the date of death from any cause
Time frame: 4 years
Event-free survival (EFS)
time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause
Time frame: 4 years
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse
Time frame: 4 years
Number of adverse events
adverse events are evaluated with CTCAE V5.0
Time frame: 2 years
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