JPRN-jRCT2080223190已完成4 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
- 4 期
- 状态
- 已完成
- 入组人数
- 117
研究概览
简要总结
Elotuzumab added to the Pd regimen improved PFS and ORR without increase in toxicity. This is the first randomized, active controlled study to demonstrate the efficacy and overall risk/benefit of a novel triplet regimen (E-Pd) based on pomalidomide-dexamethasone backbone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •At least 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
- •Documented refractory or relapsed and refractory multiple myeloma
- •Refractory to proteosome inhibitor and lenalidomide, and to last treatment
- •Relapsed and refractory patients must have 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
- •Measurable disease at screening
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
排除标准
- •Active plasma cell leukemia
- •Prior treatment with pomalidomide
- •Unable to tolerate thromboembolic prophylaxis while on the study
- •Prior autologous stem cell transplant within 12 weeks
- •Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
研究者
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