EUCTR2010-019173-16-DE进行中（未招募）1 期
Randomised phase III trial for previously untreated multiple myeloma to evaluate two regimens of bortezomib based induction therapy and lenalidomide consolidation followed by lenalidomide maintenance treatment - MM5
niversity Hospital Heidelberg0 个研究点目标入组 604 人开始时间: 2010年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 604
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
入选标准
- •newly-diagnosed symptomatic multiple myeloma (CRAB criteria)
- •measurable disease
- •age 18 - 70 years (both included)
- •WHO performance status 0-2 (WHO=3 is allowed when caused by myeloma)
- •negative pregnacy test
- •patients must be willing and capable to use adequate contraception
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •hypersensitivity to any relevant medication within the trial
- •systemic AL-amyloidosis
- •previous chemotherapy or radiotherapy during the past 5 years
- •severe cardiac dysfunction
- •significant hepatic dysfunction
- •patients known to be HIV-positive
- •other malignancy during the past 5 years
- •peripheral neuropathy CTC grade 2 or higher
研究者
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