Status:
COMPLETED
Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
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), a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2022
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT02279654
Start Date
December 17 2014
End Date
March 29 2022
Last Update
August 19 2022
Active Locations (148)
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1
Local Institution - 0001
Centre City, New Jersey, United States, ZIP CODE
2
Local Institution - 0002
Centre City, New Jersey, United States, ZIP CODE
3
Local Institution - Belgium
No City Provided, New Jersey, United States, 00000
4
Local Institution - Denmark
No City Provided, New Jersey, United States, 00000