Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
- Registration Number
- NCT02279654
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lenalidomide Population Lenalidomide 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 Background Population Lenalidomide 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
- Primary Outcome Measures
Name Time Method 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 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 Up to 3 years Number of MDS participants who survive
- Secondary Outcome Measures
Name Time Method Evaluate risk factors associated with progression of AML Up to 3 years Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide
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 Number of MDS participants who survive who have never been treated with Lenalidomide
Clinical practice Up to 3 years 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
Adverse Events Up to 3 years 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
Trial Locations
- Locations (146)
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
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
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