NCT00096837已完成2 期
An Open-Label Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Rate of complete response, partial response and stable disease (clinical benefit rate)
研究概览
简要总结
The purpose of the study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have relapsed or refractory multiple myeloma.
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
- •Relapsed or Refractory Multiple Myeloma
- •≥ 18 years old
- •Able to provide consent for participation
- •ECOG status 0-2
- •Lab values:
- •ANC ≥ 1,000/µL
- •WBC count ≥ 2.0/µL
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count ≥ 50,000/µL
- •AST and ALT ≤ 2 x ULN
- •Total Bilirubin ≤ 2 x ULN
- •Creatinine ≤ 2.0 mg/dL
- •Not pregnant or lactating
排除标准
- 未提供
结局指标
主要结局
Rate of complete response, partial response and stable disease (clinical benefit rate)
次要结局
- Progression-free survival
- Safety and tolerability
研究者
研究点 (2)
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