Overview
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
Description
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.
Eligibility
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.