Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Duration of carfilzomib treatment
研究概览
简要总结
This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).
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
- •Male or female patients over the age of 18 years
- •Patients beginning carfilzomib treatment in the framework of expanded access or compassionate use in France (KRd or Kd regimen)
- •Patients who received carfilzomib in first or second MM relapse
- •Patients receiving at least one complete course of carfilzomib
排除标准
- •Patients already included in an interventional research protocol using carfilzomib at the time of treatment initiation
- •Patients refusing to allow the computerization of their data
- •Patients for whom hospital medical records are not accessible
结局指标
主要结局
Duration of carfilzomib treatment
时间窗: 31 august 2021
Assess duration of carfilzomib treatment in adult patients with multiple myeloma who have received carfilzomib at first or second relapse according to the recommendations of the International Myeloma Working Group (time from the date of treatment initiation to the date of permanent discontinuation for any reason)
次要结局
- Progression Free survival (PFS)(31 august 2021)
- Time to next treatment(31 august 2021)