Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
A Phase 3, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of Clarithromycin(Biaxin)-Lenalidomide-Low-Dose-Dexamethasone (BiRd) Combined With B-cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Newly Diagnosed Multiple Myeloma
Lead SponsorSoochow University
Intervention/Treatmentclarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells [clarithromycin (102685), lenalidomide (16110), dexamethasone (113195), ciltacabtagene autoleucel (114980)]
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.
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.
Inclusion Criteria: Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG) Age 18-75 Eastern Cooperative Oncology Group (ECOG) score 0-2 BCMA positive as detected with flowcytometry or ELISA. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL Exclusion Criteria: Patients are pregnant or lactating. Nonsecretory MM. History of previous treatment of MM. Patients with uncontrolled active infection. Patients with active hepatitis B or hepatitis C infection. Patients with HIV infection. Patients with atrial or venous thrombosis or embolism. Patients with myo-infarction or severe arrythmia in the recent 6 months. Other comorbidities that investigators considered not suitable for this study.