NCT00305812已完成2 期
A Randomized Phase II Dose Finding Study of Revlimid™ and Melphalan in Patients With Previously Untreated Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 28
- 主要终点
- Incidence of dose-limiting toxicity within first 3 courses of 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. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as melphalan, 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 melphalan may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to undergo future autologous stem cell transplantation.
Secondary
- Characterize the toxicity profile of lenalidomide in combination with melphalan.
- Determine tumor response in these patients after 2 and 12 courses of induction therapy with lenalidomide and melphalan and after 6 months of maintenance therapy with dexamethasone.
- Determine progression-free and overall survival of these patients.
- Determine time to dose modification and time to dose discontinuation in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 120 Years（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
结局指标
主要结局
Incidence of dose-limiting toxicity within first 3 courses of treatment
次要结局
- Overall survival
- Time to progression
- Toxicity
- Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy
- Duration of disease-free interval
- Time to dose modification
- Time to dose discontinuation
研究者
研究点 (28)
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