Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 2,504
- 试验地点
- 120
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.
This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patient (age ≥ 18 yrs),
- •Diagnosed with multiple myeloma (measurable or not),
- •In whom pomalidomide treatment was first initiated between October 1, 2014, and September 30, 2019,
- •Patient already included in the Imnovid registry,
- •Having received oral and written information about the study, and having given their consent to participate.
排除标准
- •Previous participation in a clinical trial with pomalidomide,
- •Treatment with pomalidomide in a previous line,
- •Simultaneous participation in a clinical trial.
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to approximately 6 months
Is defined as the time between the date of treatment initiation with pomalidomide and the date of the first progression according to the International Myeloma Working Group (IMWG) criteria or death whatever the cause.
次要结局
- Time to Progression (TTP)(Up to 2 years)
- Overall Response Rate (ORR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Time to Treatment Failure (TTF)(Up to 2 Years)
- Adverse Events (AEs)(Up to 3 years)