NCT02528838已完成不适用
A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)
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
- 238
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.
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 over 18 years of age who understand and voluntarily sign an informed consent form.
- •Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for > 2 cycles and < 6 cycles.
- •Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment.
排除标准
- •Refusal to participate in the study.
- •Women who are pregnant or breast-feeding.
- •Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
- •Hypersensitivity to the active substance or to any of the excipients.
结局指标
主要结局
Adverse Event (AE)
时间窗: Up to approximatly 4 years
Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible
次要结局
- Reasons for discontinuation of lenalidomide(Up to approximatly 4 years)
- Lenalidomide usage patterns(Up to approximatly 4 years)
- Quality of Life(Up to approximatly 24 months)
- Clinical outcome(Up to approximately 4 years)
- Lenalodomide dose modifications(Up to approximatly 4 years)
研究者
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