NCT00044018已完成2 期
An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment 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
- 发起方
- Celgene
- 入组人数
- 102
- 试验地点
- 7
- 主要终点
- Confirmed M-Protein Response During Single Agent CDC-501 Therapy
研究概览
简要总结
The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment.
- •Subject must understand and voluntarily sign an informed consent document.
- •Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline
- •ECOG (Zubrod) performance status of 0 to
- •Subject must be able to adhere to the study visit schedule and other protocol requirements.
- •Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
排除标准
- 未提供
结局指标
主要结局
Confirmed M-Protein Response During Single Agent CDC-501 Therapy
时间窗: Response assessed every 4 weeks; up to 62 months
M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.
次要结局
未报告次要终点
研究者
研究点 (7)
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