NCT00779922已完成2 期
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population.
and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.
研究设计
- 研究类型
- Interventional
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
- •Documented diagnosis of relapsed or refractory multiple myeloma (MM).
- •Age > 18 years at the time of signing the informed consent form
- •Stable renal function
排除标准
- •Documented amyloidosis
- •Any prior use of Revlimid ®
- •Any contraindication to Revlimid ® and especially:
- •Lack of acceptable method of birth control for female of childbearing potential (FCPB)
- •Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB.
- •Pregnant or breast feeding women
研究组 & 干预措施
group 1 to 5
Experimental
干预措施: lenalidomide (Drug)
研究者
研究点 (1)
Loading locations...
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