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
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndrome
Both
Myelodysplastic Syndrome
Trial Information
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
There will be retrospective collection and integration of clinical laboratory data as well
as prospective data collection on the same patients.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort
Outcome Measure:
Number of subjects achieving red blood cell (RBC) transfusion independence
Outcome Time Frame:
14 months
Safety Issue:
No
Principal Investigator
Sante Cundari, PhD, MSc
Investigator Role:
Study Director
Investigator Affiliation:
Celgene s.r.l.
Authority:
Italy: National Bioethics Committee
Study ID:
NIPMS- Celgene-MDS-ITA-002
NCT ID:
NCT01347944
Start Date:
January 2011
Completion Date:
December 2013
Related Keywords:
- Myelodysplastic Syndrome
- MORE
- Monitoring Revlimid
- Myelodysplastic Syndrome
- Transfusion-dependent anemia
- 5q deletion
- lenalidomide
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|
