Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Days of Progression Free Survival
研究概览
简要总结
Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.
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
Zoledronic acid (ZOL446)
Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
干预措施: Zoledronic acid (Drug)
Zoledronic acid (ZOL446)
Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
干预措施: Calcium / Vitamin D (Dietary Supplement)
结局指标
主要结局
Days of Progression Free Survival
时间窗: 48 months
Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events: * progression to stage II or III according to Salmon \& Durie classification * skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia) * unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically.
次要结局
- Number of Patients With Progression by Individual Criteria(48 months)
- The Number of Participants With the Development of Skeletal Complications(48 months)