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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)
- •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
排除标准
- •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.
研究组 & 干预措施
BiRd combined with BCMA CAR T-cells infusion
干预措施: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: 4 weeks after CAR T-cells infusion (up to 14 weeks)
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.
次要结局
- Event-free survival (EFS)(4 years)
- Overall survival (OS)(4 years)
- Cumulative incidence of relapse(CIR)(4 years)
- Number of adverse events(2 years)