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临床试验/NCT02922543
NCT02922543已完成不适用

Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use

Celgene1 个研究点 分布在 1 个国家目标入组 361 人开始时间: 2011年2月18日最近更新:
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
361
试验地点
1
主要终点
Adverse Events (AEs)

研究概览

简要总结

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use.

  1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths).
  2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance.

排除标准

  • 未提供

结局指标

主要结局

Adverse Events (AEs)

时间窗: 3 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 (1)

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