EUCTR2014-000255-85-PL进行中（未招募）1 期
Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 498
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Must have documented multiple myeloma
- •- Must have received at least 1 prior line of therapy for multiple myeloma
- •- Must have documented evidence of progressive disease as defined by the
- •International Myeloma Working Group criteria on or after their last regimen - Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
- •- Must have achieved a response (partial response or better) to at least 1 prior regimen
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 192
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 288
排除标准
- •- Has received daratumumab or other anti-CD38 therapies previously
- •- Is refractory to VELCADE (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy
- •- Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
- •- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization
- •- Has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization
- •- Has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures
- •- Subject is a woman who is pregnant or breastfeeding or planning to
- •become pregnant while enrolled in this study or within 3 months after
- •the last dose of study drug.
研究者
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