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.
Study Type
OBSERVATIONAL
Enrollment
389
Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS
Local Institution - 0001
Centre City, New Jersey, United States
Local Institution - 0002
Centre City, New Jersey, United States
Local Institution - Belgium
No City Provided, New Jersey, United States
Local Institution - Denmark
No City Provided, New Jersey, United States
Local Institution - France
No City Provided, New Jersey, United States
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.
Time frame: 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
Time frame: 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 who have never been treated with Lenalidomide
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 3 years
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Local Institution - Germany
No City Provided, New Jersey, United States
Local Institution - Greece
No City Provided, New Jersey, United States
Local Institution - Italy
No City Provided, New Jersey, United States
Local Institution - Luxembourg
No City Provided, New Jersey, United States
Local Institution - Norway
No City Provided, New Jersey, United States
...and 138 more locations