NCT02193698已完成2 期
Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome
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
- 5
- 试验地点
- 1
- 主要终点
- Reduction rate of serum VEGF
研究概览
简要总结
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.
详细描述
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
- •Recurrent or refractory Crow-Fukase syndrome.
- •Patients without severe liver or renal dysfunction.
- •Patients without severe neutropenia or thrombocytopenia.
- •Patients without clinically problematic ECG findings
- •Negative on the pregnacy test on the day 1 of cycle
- •Patients who can undertake prevention of pregnancy, if necessary.
- •Patients with written informed consent.
- •Patients who are capable of ambulatory hospital visits every 4 weeks.
- •Patients with informed consent to the registration and rules of RevMate®.
排除标准
- •Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
- •Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
- •Patients who have been administered bevacizumab within 12 weeks prior to the registration.
- •Patients who could worsen acutely during the clinical trial period.
- •Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
- •Patients with malignancies.
- •Female patients who are pregnant or desire childbearing. Males who desire fertility.
- •Patients who allergic to lenalidomide or dexamethasone.
研究组 & 干预措施
Lenalidomide+Dexamethasone
Experimental
Cycle1 : Lenalidomide 15mg/day (day 1-21) Cycle2-6 : Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)
干预措施: Lenalidomide+Dexamethasone (Drug)
结局指标
主要结局
Reduction rate of serum VEGF
时间窗: after 24 weeks
次要结局
未报告次要终点
研究者
Sonoko Misawa
Associate Professor
Chiba University
研究点 (1)
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