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

Completed

• Conditions: Myelodysplastic Syndrome

• Registration Number: NCT01347944
• Lead Sponsor: Celgene

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.

Study Timeline

• Study First Submitted: 2010-10-29
• Study Start: 2011-01-01
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2013-06-30
• Study Completion: 2013-06-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with adverse events	14 months
Time to RBC transfusion independence	14 months
Duration of RBC transfusion independence	14 months
Number of participants alive	14 months
Duration of cytogenetic response	14 months
Progression to acute myeloid leukemia (AML)	14 months

Trial Locations

Locations (45)

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

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