Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 28
- 试验地点
- 26
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea.
This DUE is a non-interventional, observational and post-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications in routine clinical practice in Korea.
Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted below.
- Patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality (del [5q] MDS)
- Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL)
- Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment of patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality according to International scoring system for evaluating prognosis in myelodysplastic syndromes according to IPSS or
- •Treatment of patients with mantle cell lymphoma who have received at least one prior therapy
- •Previously treated follicular lymphoma (FL)
- •Patients who are registered in Celgene Risk Management Program" in Korea
排除标准
- •Pregnancy or females of childbearing potential
- •Hypersensitivity to the active substance or to any of the excipients (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
- •Patients with genetic disorder (e.g., galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
研究组 & 干预措施
Lenalidomide in IPSS Low-or intermediate-1-risk del population
For the IPSS Low- or intermediate-1-risk del (5q) (MDS), Lenalidomide treatment must not be started if the ANC < 0.5 x 109/L and/or platelet counts < 25 x 109/L. The recommended starting dose of lenalidomide is 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
干预措施: REVLIMID® (Drug)
Lenalidomide in Refractory/relapsed rrMC/ Follicular lymphoma population
For the Refractory/relapsed Mantle cell lymphoma (rrMCL), the recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. For the Follicular lymphoma (FL), the recommended starting dose of rituximab is 375 mg/m2 intravenously (IV) every week in Cycle 1 (days 1, 8, 15, and 22) and day 1 of every 28-day cycle for Cycles 2 through 5.
干预措施: REVLIMID® (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: From enrollment until at least 28 days after completion of study treatment
Number of participants with adverse event
次要结局
- Adverse events (AEs)(From enrollment until at least 28 days after completion of study treatment)
- To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS(Up to 4 years of Revlimid treatment period)
- To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL(Up to 4 years of Revlimid treatment period)
- To evaluate the effectiveness of REVLIMID® treatment in patients with previously treated FL(Up to 4 years of Revlimid treatment period)