Observational, Non-interventional, Multicenter Study Aimed at Collecting Retrospective/Prospective 648/96 Italian Registry Data Related to Lenalidomide (Revlimid®) Prescription to Patients With Myelodysplastic Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 149
- 试验地点
- 45
- 主要终点
- Number of subjects achieving red blood cell (RBC) transfusion independence
研究概览
简要总结
The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA) issued according to a National law named 648/96.
详细描述
There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •intermediate 1 and low risk MDS patients associated with:
- •transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )
- •5q31-33 deletion isolated or associated to other chromosomal abnormalities.
排除标准
- •patients with serum creatinine > 2.5mg/dl
- •child bearing potential females who do not use adequate contraceptive methods
结局指标
主要结局
Number of subjects achieving red blood cell (RBC) transfusion independence
时间窗: 14 months
Number of subjects achieving an erythroid response
时间窗: 14 months
Number of subjects achieving a cytogenetic response
时间窗: 14 months
次要结局
- Number of participants with adverse events(14 months)
- Time to RBC transfusion independence(14 months)
- Duration of RBC transfusion independence(14 months)
- Number of participants alive(14 months)
- Duration of cytogenetic response(14 months)
- Progression to acute myeloid leukemia (AML)(14 months)