NCT03602755已完成不适用
Retrospective Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma Between 2012 and 2016, Treated According to Routine Clinical Practice in Spain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 706
- 试验地点
- 20
- 主要终点
- Description of the first-line treatment regimens
研究概览
简要总结
This is an observational, post-authorization, retrospective, multicenter study (PAS-OD) that will be conducted in approximately 20 centers in Spain. In all cases, only data recorded prior to the date of study start will be collected to ensure its retrospective nature, thus reflecting real clinical practice, avoiding any influence on the physician's clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients aged ≥ 18 years
- •Patients with newly diagnosed MM who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive.
- •Patients who give informed consent before data collection begins.
排除标准
- •Patients who participated in a clinical trial for first-line treatment of MM during the study period.
- •Patients who are alive, but do not give their IC.
- •Patients with MM who did not receive treatment.
结局指标
主要结局
Description of the first-line treatment regimens
时间窗: Up to approximately 5 months
Number of patients in the different first-line treatment regimens, in terms of the main drug used in patients diagnosed de novo with MM who were not candidates for autologous stem cell transplantation (ASCT)
次要结局
- Overall response rate(Up to approximately 5 months)
- Duration of response(Up to approximately 5 months)
- Patients who underwent dose adjustment or switched treatment(Up to approximately 5 months)
- Overall survival (OS)(Up to approximately 5 months)
- Patients who discontinued treatment(Up to approximately 5 months)
- Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain(Up to approximately 5 months)
- Progression-free survival (PFS)(Up to approximately 5 months)
- Patients who receive second-line treatment(Up to approximately 5 months)
研究者
研究点 (20)
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