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临床试验/EUCTR2005-001628-35-BE
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

发起方
EBMT - CLWP

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