EUCTR2005-001628-35-GB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). - MMVAR
European Group for Blood and Marrow Transplantation (EBMT)0 个研究点目标入组 452 人开始时间: 2006年3月31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
入选标准
- •·Male or female =18 years-of-age
- •·Multiple myeloma with evaluable disease
- •·Relapsing or having a progressive disease at least one year after an
- •autologous transplantation
- •·Karnofsky performance status > 50 %
- •·Life expectancy of at least 3 months
- •·Female of child-bearing potential must have a method of birth control
- •and a negative serum or urine ß-HCG pregnancy test at screening and
- •all through the study
- •·Male must use contraception
- •·Voluntary 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
- •·Non-secretory Multiple myeloma
- •·Platelet count < 40,000 X 109/L
- •·Absolute neutrophil count <1.0 X 109/L
- •·Creatinine clearance <30 mL/minute
- •·Peripheral neuropaty >= Grade 2
- •·Seropositive for HIV, or active hepatitis A, B or C infection
- •·Pregnant or breastfeeding female
- •·Patient has hypersensitivity to bortezomib, boron or mannitol
- •·Other investigational drugs
- •·Serious medical or psychiatric illness
- •·Previous or concurrent malignancies at other sites
- •·Poorly controlled hypertension, uncontrolled or severe cardiovascular
- •disease or uncontrolled diabetes mellitus
- •Concurrent cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, in particular pericarditis, or cardiac amyloidosis.
- •Concurrent significant pulmonary disease, in particular interstitial pneumonia
研究者
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