A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
研究概览
简要总结
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.
详细描述
OBJECTIVES:
Primary
* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.
Secondary
- Assess the toxicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lenalidomide/Cyclophosphamide/Dexamethasone
干预措施: cyclophosphamide (Drug)
Lenalidomide/Cyclophosphamide/Dexamethasone
干预措施: dexamethasone (Drug)
Lenalidomide/Cyclophosphamide/Dexamethasone
干预措施: lenalidomide (Drug)
结局指标
主要结局
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
时间窗: Duration of Treatment (up to 5 years)
Response that was confirmed on 2 consecutive evaluations during treatment * Complete Response(CR): Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM) * Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100 mg per 24 hours; \<=5% plasma cells in BM * Partial Response PR): \>= 50% reduction in serum M-Component and/or Urine M-Component \>= 90% reduction or \<200 mg per 24 hours; or \>= 50% decrease in difference between involved and uninvolved FLC levels
次要结局
- Overall Survival (OS)(up to 5 years)
- Progression-free Survival (PFS)(up to 5 years)
- Duration of Response (DOR)(up to 5 years)