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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 269
- 试验地点
- 73
- 主要终点
- Median Time to Progression (TTP)
研究概览
简要总结
This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation.
Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone.
Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone.
详细描述
Primary Objectives:
* Test the hypothesis that treatment with Velcade plus Thalidomide plus Dexamethasone in combination, will result in a longer time to progression (TTP) than Thalidomide plus Dexamethasone in subjects with relapsed or progressive myeloma after autologous transplantation.
Secondary Objectives:
* Compare the treatment groups for: overall survival; response rate (complete & partial & minimal) using standard criteria and treatment related complications.
Study design and methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years-of-age
- •Multiple myeloma with evaluable disease
- •Relapsing or having a progressive disease
- •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 beta--human chorionic gonadotropin (β-HCG) pregnancy test at screening and all through the study
- •Male must use contraception
- •Voluntary written informed consent
排除标准
- •Non-secretory multiple myeloma
- •Platelet count < 40,000 X 10^9/L
- •Absolute neutrophil count <1.0 X 10^9/L
- •Creatinine clearance <30 mL/minute
- •Peripheral neuropathy >= 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
研究组 & 干预措施
Thal + Dex + Velcade
干预措施: Velcade (Bortezomib) (Drug)
Thal + Dex + Velcade
干预措施: Thalidomide (Drug)
Thal + Dex + Velcade
干预措施: Dexamethasone (Drug)
Thal + Dex
Standard treatment
干预措施: Thalidomide (Drug)
Thal + Dex
Standard treatment
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Median Time to Progression (TTP)
时间窗: 3 year
次要结局
- Progression Free Survival(3 year)
- Overall Survival (Interval Between Date of Randomization and Death From Any Cause(1 year)
- Response Rate (Proportion of Subjects Who Achieve Complete, Partial, or Minimal Response)(1 year)