EUCTR2014-000255-85-HU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 had documented multiple myeloma
- •-Must have received at least 1 prior line of therapy for multiple myeloma
- •Must have had documented evidence of progressive disease as defined based on Investigator’s determination of response of International Myeloma Working Group (IMWG) 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 [PR] or better based on investigator’s determination of response by the IMWG criteria) to at least 1 prior regimen in the past
- •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 antiCD38 therapies previously
- •Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy or another PI therapy, like ixazomib and carfilzomib
- •Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
- •Has received antimyeloma treatment within 2 weeks or 5 pharmacokinetic halflives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. A list of antimyeloma treatments with the corresponding pharmacokinetic halflives is provided in the Site Investigational Product Procedures Manual (IPPM).
- •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
研究者
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