EUCTR2010-021857-38-SE进行中（未招募）1 期
Randomized phase II Trial comparing Lenalidomide with lowdose dexamethasone versus Lenalidomide inSecond Line Multiple Myeloma (MM)
Karolinska University Hospital0 个研究点目标入组 60 人开始时间: 2010年12月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Be at least 18 years of age
- •2. Have a confirmed diagnosis of MM
- •3. Have received lenalidomide after one prior treatment for MM and have reached at least a partial response (PR),
- •according to IMWG criteria, including two consolidating cycles.
- •4. Have personally signed and dated a legally effective written informed consent (Appendix 1) form prior to
- •admission to the study.
- •5. Must be willing and able to understand and comply with the study requirements.
- •6. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.
- •7. Male must agree to practice contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
- •2. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to
- •3. Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical
- •condition that might affect their experience of myeloma symptoms or their ability to describe them.
- •4. Pregnant or lactating females
- •5. Any other clinically significant medical disease or condition that, in the Investigator´s opinion, may interfere
- •with protocol adherence or a subject´s ability to give informed consent.
研究者
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