NCT00330759已完成3 期
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,779
- 主要终点
- Time to the First On-Study Skeletal-Related Event (Non-Inferiority)
研究概览
简要总结
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
- •Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG performance status 0, 1, or 2
- •Adequate organ function
排除标准
- •Diagnosis of breast or prostate cancer
- •Current or prior intravenous bisphosphonate administration
- •Current or prior oral bisphosphonates for bone metastases, life expectancy of less than 6 months
- •Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
研究组 & 干预措施
zoledronic acid
Active Comparator
denosumab placebo with active zoledronic acid
干预措施: Zoledronic Acid (Drug)
denosumab
Experimental
active denosumab with zoledronic acid placebo
干预措施: Denosumab (Biological)
结局指标
主要结局
Time to the First On-Study Skeletal-Related Event (Non-Inferiority)
时间窗: up to 33 months
Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.
次要结局
- Time to the First-and-Subsequent On-Study Skeletal-Related Event(up to 33 months)
- Time to First On-Study Skeletal-Related Event (Superiority)(up to 33 months)
研究者
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