NCT02075996已完成不适用
Non-interventional Study of Pomalidomide (Imnovid®) in Combination With Dexamethasone in Patients With Relapsed or Refractory 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
- 151
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this non-interventional study is to collect data on the efficiency and safety of pomalidomide in combination with dexamethasone in the routine application
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 relapsed or refractory multiple myeloma Patients must have received at least two prior lines of treatment (induction therapy followed by stem cell transplantation ± maintenance therapy is considered one prior therapy) and must have progressed under the most recent therapy regimen
- •Adult male and female patients (at least 18 years with no upper age limit)
- •Written informed consent to data collection and pseudonymized data transfer
- •The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential (see summary of product characteristics Imnovid®)
- •Other criteria according to summary of product characteristics Imnovid®
排除标准
- •Missing patient's informed consent
- •Pregnant or breast-feeding women
- •Male patients, not capable of complying the required preventive measures (see summary of product characteristics Imnovid®)
- •Other criteria according to summary of product characteristics Imnovid®
结局指标
主要结局
Progression free survival (PFS)
时间窗: 6 years
次要结局
- secondary malignancies(6 years)
- adverse reaction profile(3 years)
- relative dose intensity of pomalidomide and dexamethasone(3 years)
- explore additional supportive therapies(3 years)
- Time to Treatment Discontinuation (TTD)(6 years)
- Time to next treatment (TNT)(6 years)
- overall Survival (OS)(6 years)
- Overall Response Rate (ORR)(6 years)
- assess changes in myeloma-related quality of life(3 years)
研究者
研究点 (1)
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