EUCTR2017-002238-21-SE进行中（未招募）1 期
A Phase 3 randomized, open-label, multicenter study assessing the clinical benefit of isatuximab (SAR650984) in combination with bortezomib (Velcade®), lenalidomide and dexamethasone versus bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma not eligible for transplant - Imroz
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •-Multiple myeloma (International Myeloma Working Group [IMWG] criteria).
- •-Newly diagnosed multiple myeloma not eligible for transplant due to age (= 65 years) or patients < 65 years with comorbidities impacting possibility of transplant.
- •-Evidence of measurable disease.
- •-Written informed consent.
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 220
排除标准
- •-Age < 18 years.
- •-Prior treatment for multiple myeloma.
- •-Any other prior or ongoing disease/health conditions incompatible with the study objectives.
- •-Organ function values not met.
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status ( PS) > 2.
- •-Hypersensitivity to the study medications.
- •-Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods.
- •-Male participants who disagree to follow the study contraceptive counseling.
研究者
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