EUCTR2005-001628-35-BE进行中(未招募)1 期
A randomized controlled study of Velcade (Bortezomib) plus Thalidomide plus Dexamethasone compared to Thalidomide plus Dexamethasone for the treatment of myeloma patients progressing or relapsing after autologous transplantation - MMVAR
EBMT - CLWP0 个研究点目标入组 452 人开始时间: 2005年12月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 452
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
- •-histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters
- •-relapsing or having a progressive disease at least one year after an autologous transplantation
- •-karnofsky index more than 50%
- •-post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
- •-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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-patient with non-secretory MM
- •-Creat clearance lower than 30 ml/min, platelets lower then 40000, ANC lower than 1000
- •-peripheral neuropathy of grade 2 or more within 14 days before enrollment
- •-HIV, hepatitis A,B,C positive
- •-female subject pregnant or breast-feeding
研究者
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