MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry (MORE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.
Observational, Non-interventional, Multicenter Study Aimed at Collecting Retrospective/Prospective 648/96 Italian Registry Data Related to Lenalidomide (Revlimid®) Prescription to Patients With Myelodysplastic Syndromes
Actual Study Start Date :
January 1, 2011
Actual Primary Completion Date :
June 30, 2013
Actual Study Completion Date :
June 30, 2013
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients affected by intermediate-1 and low risk MDS associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present.
intermediate 1 and low risk MDS patients associated with:
transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )
5q31-33 deletion isolated or associated to other chromosomal abnormalities.
patients with serum creatinine > 2.5mg/dl
child bearing potential females who do not use adequate contraceptive methods