NCT02279654

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 389 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Lenalidomide	Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS

Timeline

• Start date: 2014-12-17
• Primary completion: 2022-03-29
• Completion: 2022-03-29
• First posted: 2014-10-31
• Last updated: 2022-08-19

Locations

148 sites across 12 countries: United States, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, Norway, Spain, Sweden, United Kingdom