JPRN-jRCT1080221832已完成4 期
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 1,718 人开始时间: 2012年6月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,718
研究概览
简要总结
oninferiority was demonstrated for the primary endpoint of time to first on-study SRE based on the 2-stage approach. Overall, the subject incidence of treatment-emergent adverse events, grade >= 3 events, serious adverse events, events leading to discontinuation of investigational product or study, and fatal adverse events was similar between the two treatment groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Adults with newly diagnosed multiple myeloma
- •-Radiographic evidence of at least 1 bone lesion
- •-Plan to receive primary frontline anti-myeloma therapies
- •-Adequate organ function
- •-Written informed consent
排除标准
- •-Nonsecretory multiple myeloma (unless baseline serum free light chain level is elevated)
- •-Plasma cell leukemia
- •-POEMS syndrome
- •-Previous treatment with anti-myeloma therapy
- •-Prior administration of denosumab-
- •-Use of oral bisphosphonates with a cumulative exposure of more than 1 year
- •-More than 1 previous dose of IV bisphosphonate administration
- •-Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw
研究者
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