A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
研究概览
简要总结
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with primary systemic amyloidosis.
详细描述
OBJECTIVES:
Primary
* Assess the hematologic response rate in patients with primary systemic amyloidosis treated with lenalidomide, cyclophosphamide, and dexamethasone.
Secondary
- Determine the organ response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the survival of patients treated with this regimen.
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
CRD
Lenalidomide 15mg daily (days 1-21)
Cyclophosphamide 300 mg/m^2 (days 1, 8, 15)
Dexamethasone 40 mg weekly
干预措施: cyclophosphamide (Drug)
CRD
Lenalidomide 15mg daily (days 1-21)
Cyclophosphamide 300 mg/m^2 (days 1, 8, 15)
Dexamethasone 40 mg weekly
干预措施: dexamethasone (Drug)
CRD
Lenalidomide 15mg daily (days 1-21)
Cyclophosphamide 300 mg/m^2 (days 1, 8, 15)
Dexamethasone 40 mg weekly
干预措施: lenalidomide (Drug)
结局指标
主要结局
Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
时间窗: Duration on study (up to 3 years)
Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. 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
- Number of Patients With Organ Response(Duration of study (up to 3 years))
- Number of Participants With Severe Adverse Events(Duration of study (up to 3 years))
- Progression Free Survival (PFS)(Duration of study (up to 3 years))
- Overall Survival (OS)(Duration of study (up to 3 years))