NCT01450215已完成2 期
Randomized Trial Comparing Lenalidomide With Low Dose Dexamethasone Versus Lenalidomide in Second Line Multiple Myeloma
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Time to progression
研究概览
简要总结
This is:
- A prospective, randomized, open, phase II, multi-centre, interventional study. Patients who are in at least PR and have received lenalidomide as 2nd line treatment for MM will be recruited.
- The patients will be randomized into two groups. Group R will receive lenalidomide 25 mg/day p.o. continuously for 21 days and group Rb will receive a similar dose of lenalidomide with the addition of 40 mg of dexamethasone p.o. on days 1, 8, 15 and 22 of every 28 day treatment cycle. Study includes a maximum of 24 cycles including two consolidating cycles per patients.
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
- 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
- •Inclusion Criteria - all subjects must:
- •Be at least 18 years of age
- •Subjects must have a documented diagnosis of MM and have either refractory or relapsed and refractory after first line treatment disease defined as:
- •Primary refractory
- •Refractory
- •Relapsed and Refractory
- •Subjects must have undergone prior treatment with one treatment line of anti-myeloma therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line.Have a confirmed diagnosis of MM
- •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. Subjects have experienced a response at least PR after starting treatment with lenalidomide and cortisone cycles.
- •Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
- •Must be willing and able to understand and comply with the study requirements.
- •Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception.
- •Male must agree to practice contraception
排除标准
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,000/µL
- •Platelet count < 75,000/ µL
- •Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula
- •Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •Serum total bilirubin > 2.0 mg/dL
- •ECOG performance status <
- •Individuals who have had a stem-cell transplant as a 2nd line treatment for MM
- •Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
- •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.
- •Pregnant or lactating females.
- •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.
研究组 & 干预措施
Revlimid
Experimental
干预措施: Revlimid (Drug)
结局指标
主要结局
Time to progression
时间窗: 24 months
次要结局
- Number of Participants with Adverse Events(participants will be followed for the duration of hospital stay, an expected average of 2 years)
研究者
Hareth Nahi
MD, PhD, clinical assoc.professor
Karolinska University Hospital
研究点 (2)
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