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

Celgene149 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

Myelodysplastic Syndrome

Interventions

lenalidomideDRUG

Patients who were prescribed Revlimid from 31October 2008 to present.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (45)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Dipartimento Onco - Ematologico Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo

Alessandria, Italy

Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia

Asti, Italy

Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari

Bari, Italy

Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno

Belluno, Italy

Ematologia A.O. Ospedale Riuniti di Bergamo

Bergamo, Italy

Dip. Medicina Interna Ospedale degli Infermi di Biella

Biella, Italy

Dipartimento di Ematologia Spedale Civili di Brescia

Brescia, Italy

Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia

Brescia, Italy

Dipartimento di Ematologia Ospedale R. Binaghi

Cagliari, Italy

...and 35 more locations