A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a real-world setting (versus a clinical trial).
详细描述
The REVLIMID Registry is a prospective, multi-center, observational study. The registry will register 100 patients being prescribed REVLIMID in Taiwan during and patients will be followed for two years after the enrollment of the last patient.
Safety and efficacy data will be recorded in the registry monthly or bi-monthly. In accordance with the Risk Minimization Program for REVLIMID (RevAssure) a patient categorized as a woman of childbearing potential will be prescribed REVLIMID on a monthly basis, whereas women of non-childbearing potential and men will be allowed up to two months supply per prescription.
After entry of baseline data, the prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI)
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
- •Adult patients 18 years of age or older
- •Patients that are being prescribed REVLIMID in combination with dexamethasone for the treatment of multiple myeloma and that have received at least one prior therapy
- •Patient must be willing and able to provide informed consent
- •Patients will be informed about the Registry and will have to sign a specific Registry Informed Consent Form
- •Be able to ask questions prior to signing the Subject Information and Consent Form
- •Be clearly informed that their involvement/participation in the registry is voluntary
- •Understand that their medical care will not be altered in any way by their participation in the registry
排除标准
- •A Patient who is unwilling or unable to provide informed consent will not be included.
研究组 & 干预措施
REVLIMID
Taiwanese patients treated with REVLIMID
干预措施: Revlimid (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to two years
Number of participants with adverse events
次要结局
- Efficacy(Up to two years)