NCT00911105已完成不适用
Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 101
- 试验地点
- 17
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with multiple myeloma with at least one previous therapy.
- •18 years or older
- •Signed, written informed consent
排除标准
- •Pregnancy or nursing
- •All other exclusion criteria listed in SmPC (summary of product characteristics)
结局指标
主要结局
Time to progression (TTP)
时间窗: maximum 3 years per Patient
次要结局
- Kidney Function(maximum 3 years per Patient)
- Thrombosis Prophylaxis(maximum 3 years per Patient)
- Overall Response Rate(maximum 3 years per Patient)
- Time to Treatment Discontinuation (TTD)(maximum 3 years per Patient)
- Overall Survival (OS)(maximum 3 years per Patient)
- Safety Profile(maximum 3 years per Patient)
- Dosage of Lenalidomide and Dexamethasone(maximum 3 years per Patient)
- Neutropenia / Infection (Concomitant Medication)(maximum 3 years per Patient)
研究者
研究点 (17)
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