REVLIMID® Drug Use Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 624
- 试验地点
- 25
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
The main purpose of REVLIMID® DUE (Drug Use Examination) is to collect and evaluate the safety information of Korean Multiple Myeloma patients treated with REVLIMID® according to the approved package insert, after approval of marketing authorization for new drug in Korea. In addition, the efficacy information of REVLIMID® in clinical practice is collected and evaluated. This DUE is a multi-centre, observational and non-interventional post-marketing surveillance.
The patients can be recruited through both Drug Use Examination after the initiation of Post Marketing Surveillance(contract with institution) and Patient Access Program(PAP) that was performed before REVLIMID® reimbursement.
Total 624 patient has enrolled in PMS by 07Sep2016. Validation process for eligibility for safety assessment has been conducted by site monitoring process by 07Dec2016.
REVLIMID® DUE is to investigate frequency and change of Adverse Events(AEs) /Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors influencing safety & efficacy of the drug.
It is necessary to examine patients' demographics and baseline characteristics, medical history, status of REVLIMID® treatment, concomitant medication and evaluation of safety and final efficacy (best response) assessment.
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
- 否
入选标准
- •Korean male or female who are diagnosed with Multiple Myeloma
- •In-patients or out patients during the REVLIMID® Drug Use Examination period who are intended to be treated with REVLIMID ®
- •Patients who are registered for Risk Management Program of Celgene
排除标准
- •There's no exclusion criteria
研究组 & 干预措施
Korean patients
All Korean patients intended to be treated with REVLIMID® according to the approved package insert
干预措施: REVLIMID® (Drug)
Korean patients
All Korean patients intended to be treated with REVLIMID® according to the approved package insert
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Up to 6 years
Number of participants with adverse events
次要结局
- Overall response rate(Up to 6 years)