A Phase III Randomized Trial of Thalidomide Plus Zoledronic Acid Versus Zoledronic Acid Alone in Patients With Early Stage Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Time to Disease Progression (TTP)
研究概览
简要总结
RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet know whether giving zoledronate together with thalidomide is more effective than zoledronate alone in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Compare time to progression in patients with early stage multiple myeloma treated with zoledronate with or without thalidomide.
Secondary
- Compare the response rate, 1-year progression-free survival rate, duration of response, and time to next therapy in patients treated with these regimens.
- Assess differences in toxicity of these regimens in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I: Thal/ZLD
Thalidomide (Thal) + Zolendronic acid (ZLD)
干预措施: Thalidomide (Drug)
Arm I: Thal/ZLD
Thalidomide (Thal) + Zolendronic acid (ZLD)
干预措施: zoledronic acid (Drug)
Arm II: ZLD
Zoledronic acid (ZLD)
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Time to Disease Progression (TTP)
时间窗: randomization to progression (up to 5 years)
Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.
次要结局
- 12-month Progression-free Survival (PFS)(12 months)
- Number of Participants With a Confirmed Response (Complete Response [CR], Very Good Partial Response [VGPR] or Partial Response [PR]) on Two Consecutive Evaluations at Least 2 Weeks Apart in the First 12 Months of Treatment(12 months)
- Duration of Response (Complete Response, Partial Response, and Very Good Partial Response)(time from start of response to progression (up to 5 years))
- Time to Subsequent Treatment(time from end of treatment to subsequent treatment (up to 5 years))
- Time to Treatment Failure(time from randomization to treatment failure (up to 5 years))
- Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events(During treatment (up to 5 years))