A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 389
- 试验地点
- 146
- 主要终点
- Ascertain the Disease Progression to AML (through calculation of product limit estimators and incidence rates) for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q and have been treated with Revlimid
研究概览
简要总结
This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)].
The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are ≥ 18 years old at the time of signing the Informed consent form (ICF)
- •Are transfusion dependent or have an history of transfusion dependence; for the purpose of the current Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS), transfusion-dependence is defined as requiring ≥2 RBC units over an 8 week period prior to the date of signature on the ICF (due to MDS-related causes and not because of hemorrhage, trauma, or other acute cause)
- •Are on active treatment with lenalidomide (Lenalidomide Cohort) or have never been exposed to lenalidomide at the time of signing the ICF (Background Cohort)
- •Have confirmed diagnosis of IPSS low or intermediate-1-risk MDS with isolated del (5q) (with morphological and cytogenetic information) diagnosed on 15 June 2007 (date of Revlimid first approved in Europe) or later
排除标准
- •Refuse to participate in the Myelodysplastic syndromes (MDS) Post-authorization safety study (PASS),
- •Are currently participating in an interventional therapeutic clinical trial for MDS (except for erythropoiesis-stimulating agents [ESAs] and granulocyte colonystimulating growth factors)
- •Receive any investigational agent the time of signing the ICF
- •Have previously been treated with lenalidomide and are no longer on active treatment with lenalidomide at the time of signing the ICF
研究组 & 干预措施
Lenalidomide Population
Patients with transfusion-dependent, low- or intermediate (int)-1risk MDS and isolated del (5q) who receive at least 1 dose of lenalidomide after 15th June 2007 and have been followed up for on the registry for 3 years or until death/consent withdrawal
干预措施: Lenalidomide (Drug)
Background Population
All MDS patients who have been diagnosed on 15th June 2007 or later, have never been exposed to lenalidomide and have been followed up on the registry for 3 years or until death/consent withdrawal
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Ascertain the Disease Progression to AML (through calculation of product limit estimators and incidence rates) for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q and have been treated with Revlimid
时间窗: Up to 3 years
Incidence, as well as the attributable risk (AR) and AR percent (%). Progressive Disease criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide
时间窗: Up to 3 years
Number of MDS participants who survive
次要结局
- Evaluate risk factors associated with progression of AML(Up to 3 years)
- Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide(Up to 3 years)
- Clinical practice(Up to 3 years)
- Adverse Events(Up to 3 years)