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Completed

NCT Number: NCT01347944

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

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.

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • intermediate 1 and low risk MDS patients associated with:
  • transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )
  • 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

Treatment and study plan

Lenalidomide

Drug

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

Other names: Revlimid®

Primary outcomes

  1. Number of subjects achieving red blood cell (RBC) transfusion independence

    Time frame: 14 months

  2. Number of subjects achieving an erythroid response

    Time frame: 14 months

  3. Number of subjects achieving a cytogenetic response

    Time frame: 14 months

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: 14 months

  2. Duration of RBC transfusion independence

    Time frame: 14 months

  3. Duration of cytogenetic response

    Time frame: 14 months

  4. Time to RBC transfusion independence

    Time frame: 14 months

  5. Progression to acute myeloid leukemia (AML)

    Time frame: 14 months

  6. Number of participants alive

    Time frame: 14 months

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Acronym: MORE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 5, 2011
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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