EUCTR2010-020454-34-GB进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 1,700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults with documented evidence of multiple myeloma (per local assessment);
- •- Radiographic evidence of at least 1 bone lesion;
- •- Plan to receive or is receiving primary frontline anti-myeloma therapies;
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
- •- Adequate organ function;
- •- Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 626
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1074
排除标准
- •- Nonsecretory multiple myeloma (unless baseline serum free light chain level is elevated);
- •- Plasma cell leukemia;
- •- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome;
- •- More than 30 days of previous treatment (before screening) with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 60 mg/day for 4 days]).
- •- Planned radiation therapy or surgery to bone (does not include procedures;
- •performed before randomization)
- •- Prior administration of denosumab;
- •- More than 1 previous dose of IV bisphosphonate administration;
- •- Use of oral bisphosphonates with a cumulative exposure of more than 1 year;
- •- Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw.
研究者
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