EUCTR2014-003282-19-FR进行中（未招募）1 期
An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in relapsed and 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
- 150
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
- •(1) = 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination.
- •(2) Documented refractory or relapsed and refractory multiple myeloma
- •(3) Refractory to proteosome inhibitor and lenalidomide, and to their last treatment
- •(4) Relapsed and refractory patients had achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment.
- •(5) Measurable disease at screening
- •(6) Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •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 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •(1) Active plasma cell leukemia
- •(2) Prior treatment with pomalidomide
- •(3) Unable to tolerate thromboembolic prophylaxis while on the study
- •(4) Prior autologous stem cell transplant within 12 weeks
- •(5) Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
研究者
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