Clinical Trial: MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Observational, Non-interventional, Multicenter Study Aimed at Collecting Retrospective/Prospective 648/96 Italian Registry Data Related to Lenalidomide (Revlimid®) Prescription to Patients With M
Brief Summary: The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA) issued according to a National law named 648/96.
Detailed Summary: There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.
Sponsor: Celgene Corporation
Current Primary Outcome:
- Number of subjects achieving red blood cell (RBC) transfusion independence [ Time Frame: 14 months ]
- Number of subjects achieving an erythroid response [ Time Frame: 14 months ]
- Number of subjects achieving a cytogenetic response [ Time Frame: 14 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants with adverse events [ Time Frame: 14 months ]
- Duration of RBC transfusion independence [ Time Frame: 14 months ]
- Duration of cytogenetic response [ Time Frame: 14 months ]
- Time to RBC transfusion independence [ Time Frame: 14 months ]
- Progression to acute myeloid leukemia (AML) [ Time Frame: 14 months ]
- Number of participants alive [ Time Frame: 14 months ]
Original Secondary Outcome: Same as current
Information By: Celgene Corporation
Dates:
Date Received: October 29, 2010
Date Started: January 2011
Date Completion:
Last Updated: March 23, 2016
Last Verified: March 2016
