NCT00430365已完成3 期
Relevance of Maintenance Therapy Using Lenalidomide (Revimid®) After Autologous Stem Cell Transplantation Patients Under the Age Of 65. (Open, Randomised, Multi-centric Trial Versus Placebo).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 143
- 主要终点
- Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
研究概览
简要总结
Maintenance treatment of myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No signs of progression after transplant
- •Effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males)
- •No active severe infection
- •Satisfactory restoration of the haematological parameters defined by: PN >1,000/mm3 and Platelets > 75,000/mm3
- •Bilirubin < 35 umol/l and GOT/GPT/PAL<3N
- •Creatinine < 160 umol/l.
排除标准
- 未提供
研究组 & 干预措施
placebo group
Placebo Comparator
Administration of oral placebo
干预措施: placebo (Drug)
lenalidomide group
Experimental
Administration of lenalidomide
干预措施: lenalidomide (Drug)
结局指标
主要结局
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
时间窗: 2 years
次要结局
- Assess the impact of Revlimid® on the post-transplant complete response rate(2 years)
- Compare survival without events and overall survival of patients in the lenalidomide arm with the control(2 years)
- Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.(3 years)
研究者
研究点 (143)
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