NCT02608515已完成不适用
A Retrospective Chart Review Study of the Outcomes of Second Line Therapy With LEnalidomide/Dexamethasone in Greek Patients With Relapsed/Refractory Multiple MyEloma and the Treatment PatterNs Following Progressive Disease, "The LEGEND Study"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse
研究概览
简要总结
This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subjects must fulfill ALL of the following criteria:
- •Subjects of both genders, aged 18 years or older
- •Subjects must have a relapsed or refractory MM diagnosis according to IMWG or EBMT criteria
- •Subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' Summary of Product Characteristics (SmPC) between 01 January 2009 and 01 March 2014
- •Subjects must have available medical files/records and detailed historical data on their disease course and clinical management
- •Provision of signed ICF for collecting and analyzing medical data pertinent to the objectives of this study
排除标准
- •For the candidate subjects NONE of the following criteria should apply:
- •Prior malignancy (within the 3 years preceding initial diagnosis of MM)
- •Concurrent administration of anti-cancer regimens for malignancies other than MM between the time of initial MM diagnosis and time of second relapse
- •Subject participation in an interventional study
结局指标
主要结局
Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse
时间窗: 12 months
PFS rate
次要结局
未报告次要终点
研究者
研究点 (1)
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