A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.
Overview
- Phase
- Not Applicable
- Intervention
- Lenalidomide
- Conditions
- Myelodysplastic Syndrome
- Sponsor
- Celgene
- Enrollment
- 389
- Locations
- 146
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Lenalidomide
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
Intervention: Lenalidomide
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: Up to 3 years
Number of MDS participants who survive
Secondary Outcomes
- 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)