NL-OMON55578已完成3 期
Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma - POLLUX
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Must have documented multiple myeloma and measurable disease
- •- Must have received at least 1 prior line of therapy for multiple myeloma and
- •achieved a response (partial response or better) to at least one prior regimen
- •- 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
排除标准
- •- Has received any of the following therapies: daratumumab or other anti-CD38
- •- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic
- •half-lives of the treatment
- •- Disease shows evidence of refractoriness or intolerance to lenalidomide or if
- •previously treated with a lenalidomide-containing regimen the participant is
- •excluded if he or she discontinued due to any adverse event related to prior
- •lenalidomide treatment
- •- Has received autologous stem cell transplantation within 12 weeks before the
- •date of randomization, or previously received an allogenic stem cell transplant
- •(regardless of timing), or planning to undergo a stem cell transplant prior to
- •progression of disease
- •- History of malignancy (other than multiple myeloma) within 3 years before the
- •date of randomization
研究者
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