MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry

Celgene

Status: Completed

Conditions: Myelodysplastic Syndrome

Treatments: Drug: lenalidomide

Study type: Observational

Funder types: Industry

Identifiers

NCT01347944

NIPMS- Celgene-MDS-ITA-002

Details and patient eligibility

About

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.

Full description

There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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