Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria
研究概览
简要总结
BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study
排除标准
- •Not Applicable
结局指标
主要结局
Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria
时间窗: Up to 72 weeks
Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria
时间窗: Up to 72 weeks
Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria
时间窗: Up to 72 weeks
Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria
时间窗: Up to 72 weeks
Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan
时间窗: Up to 72 weeks
Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria
时间窗: Up to 72 weeks
Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan
时间窗: Up to 72 weeks
immune-related (IR) adverse events are defined as: 1) AEs that are related to elotuzumab per investigator and 2) are consistent with an inflammatory process.
Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria
时间窗: Up to 72 weeks
次要结局
未报告次要终点