NCT03660072撤回不适用
Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2022年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of AE's and SAE's
研究概览
简要总结
This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)
排除标准
- •Participants who use Empliciti for therapeutic indications which are not approved for Empliciti combination therapy in Korea
- •Patients in whom treatment with Empliciti (as clarified in the Korean label) is contraindicated
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of AE's and SAE's
时间窗: 24 Months
次要结局
- Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone(24 Months)
- Overall response of Empliciti treatment with lenalidomide and dexamethasone(24 Months)
研究者
研究点 (1)
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