Risk Stratification and MRD-driven Maintenance for Multiple Myeloma After Autologous Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- MRD (Minimal Residual Disease) status at 12 months after maintenance
研究概览
简要总结
This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation.
This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT.
- •Must have a partial response (PR) or better response before maintenance.
- •Must have an Eastern Cooperative Oncology Group performance status score of 0, 1, or
- •This study allows for post-ASCT consolidation therapy.
- •ANC ≥ 1.0 x 10^9/L, Hb ≥ 85 g/L PLT ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%).
- •No active infection.
- •a).TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b).AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 45mL/min.
排除标准
- •Must not refractory or non-tolerate to lenalidomide in Arm A.
- •Must not refractory or non-tolerate to lenalidomide and daratumumab in Arm B.
- •Must not have progressed on multiple myeloma (MM) therapy before screening
- •Chronic obstructive pulmonary disease (COPD) with FEV1 less than 50 % of predicted normal；
- •Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
- •History of stroke or serious thrombotic event within 12 months prior to screening.
研究组 & 干预措施
Lenalidomide
For patients with low-risk or intermediate-low risk and minimal residual disease negativity before maintenance
干预措施: Lenalidomide (Drug)
Daratumumab and Lenalidomide
For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance
干预措施: Daratumumab (Drug)
Daratumumab and Lenalidomide
For patients with high-risk or intermediate-high risk OR minimal residual disease posivitity before maintenance
干预措施: Lenalidomide (Drug)
结局指标
主要结局
MRD (Minimal Residual Disease) status at 12 months after maintenance
时间窗: 12 months
Bone marrow minimal residual disease status at 12 months after maintenance
次要结局
- CR+VGPR(12 months)
- Estimated 3 year-PFS(3 years)
- Estimated 3 year OS(3 years)
- TRAEs(3 years)
研究者
Jin Lu, MD
Principal of Investigator
Peking University People's Hospital