Myelodysplastic Syndrome
Conditions
Keywords
MORE, Monitoring Revlimid, Myelodysplastic Syndrome, Transfusion-dependent anemia, 5q deletion, lenalidomide
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 description
There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.
Interventions
DRUGlenalidomide
Patients who were prescribed Revlimid from 31October 2008 to present.
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* intermediate 1 and low risk MDS patients associated with: 1. transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment ) 2. 5q31-33 deletion isolated or associated to other chromosomal abnormalities.
Exclusion criteria
* patients with serum creatinine \> 2.5mg/dl * child bearing potential females who do not use adequate contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects achieving red blood cell (RBC) transfusion independence | 14 months |
| Number of subjects achieving an erythroid response | 14 months |
| Number of subjects achieving a cytogenetic response | 14 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to RBC transfusion independence | 14 months |
| Number of participants with adverse events | 14 months |
| Number of participants alive | 14 months |
| Progression to acute myeloid leukemia (AML) | 14 months |
| Duration of RBC transfusion independence | 14 months |
| Duration of cytogenetic response | 14 months |
Countries
Italy
Outcome results
None listed