Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

Study Overview
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Brief Summary
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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.

Official Title
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A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.

Conditions
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Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: Lenalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lenalidomide Population<br>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 | Drug: Lenalidomide<br>* Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS<br>* Other names: CC-5013;|
| Background Population<br>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 | Drug: Lenalidomide<br>* Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS<br>* Other names: CC-5013;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | Number of MDS participants who survive | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide | Number of MDS participants who survive who have never been treated with Lenalidomide | Up to 3 years | 
| Adverse Events | Type, frequency, severity of advere events and relationship of adverse events to Lenalidomide. An adverse ecent is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, ie, any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product | Up to 3 years | 
| Evaluate risk factors associated with progression of AML | Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide | Up to 3 years | 
| Clinical practice | Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients in MDS participants | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transfusion-dependent, Lenalidomide, Revlimid, international Prognostic Scoring System (IPSS) low, Intermediate-1-risk, MDS, Isolated del(5q), Prospective, Non-interventional, Post-authorization safety study (PASS), Disease registry