A Non-interventional, Multi-center, Observational Post Authorization Safety Study of Patients With Relapse/Refractory Multiple Myeloma Treated With Lenalidomide in Turkey
试验速览
- 阶段
- 不适用
- 发起方
- Celgene
- 入组人数
- 500
- 试验地点
- 38
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in Turkey.
The study is anticipated to last for approximately 8 years. Recruitment period will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide.
详细描述
Objectives:
-
Primary: To characterize and determine the incidence of adverse events of special interest; in subjects treated with Lenalidomide in real life setting in given indication.
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Secondary:
- To observe the basic adverse event management approaches of physicians
- To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the prescription line.
- To monitor the reasons of patients' noncompliance with lenalidomide usage recommended in Patient Information Leaflet.
Subjects will be recruited from approximately 36 hematology/oncology sites in Turkey. In all cases, the decision to treat the patient will be made prior to the decision to enter the subject into the study. All subjects enrolled will be prospectively followed up for up to 36 months, where feasible, following the end of observed treatment period. This 36 month observation period will start from end of treatment. The observation follow up period will end 36 months after the end of lenalidomide or background observed treatment period, or at time of death, withdrawal of consent, or loss to follow up. Following completion of treatment, subjects will be followed up after 30 days and then every 6 months to assess status.
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
- •Male or female multiple myeloma patients with ≥18 years of age.
- •Subjects who understand and voluntarily sign an informed consent
- •Subjects who are receiving lenalidomide treatment in combination with dexamethasone not longer than four weeks.
排除标准
- •- Refusal to participate in the study.
- •Patients who are currently on an interventional clinical trial
- •Subjects who previously received lenalidomide treatment and whose treatment is ceased or who had a treatment interruption for four weeks or longer.
结局指标
主要结局
Adverse Events (AEs)
时间窗: Up to 5 years
Number of participants with Adverse Events
次要结局
未报告次要终点
