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临床试验/NCT02387879
NCT02387879Unknown不适用

A Non-interventional, Multi-center, Observational Post Authorization Safety Study of Patients With Relapse/Refractory Multiple Myeloma Treated With Lenalidomide in Turkey

Celgene38 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年12月25日最近更新:
适应症

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.

  • Secondary:

  1. To observe the basic adverse event management approaches of physicians
  2. To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the prescription line.
  3. 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

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

研究者

发起方
Celgene
申办方类型
Industry
责任方
Sponsor

研究点 (38)

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