NCT00166413已完成2 期
A Phase II Trial of CC-5013 in Patients With Primary Systemic Amyloidosis
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
- Mayo Clinic
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis
研究概览
简要总结
Patients with primary systemic amyloidosis will be treated with CC-5013 (lenalidomide; Revlimid) as a single agent for 3 months. If their disease worsens or does not improve during that time frame dexamethasone will be added to the treatment program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CC5013
Experimental
Assess the proportion of confirmed hematologic responses (HCR, HPR) resulting from treatment with CC5013 after 3 months in patients with primary systemic amyloidosis.
干预措施: CC-5013 (Drug)
结局指标
主要结局
To evaluate the hematologic response rate of CC-5013 in patients with primary systemic amyloidosis
时间窗: 12 months
次要结局
- Toxicity of single agent CC-5013 and combination CC-5013 and dexamethasone(12 months)
- Hematologic response rate of CC-5013 and dexamethasone(12 months)
- Organ response of CC-5013 and the CC-5013 dexamethasone combination(12 months)
- Time to progression(5 years)
- Survival(5 years)
研究者
研究点 (1)
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