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

November 14, 2019 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Dipartimento Onco - Ematologico Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo
      • Ancona, Italy, 60100
        • Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona
      • Asti, Italy, 14100
        • Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia
      • Bari, Italy, 70124
        • Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari
      • Belluno, Italy, 32100
        • Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno
      • Bergamo, Italy, 24128
        • Ematologia A.O. Ospedale Riuniti di Bergamo
      • Biella, Italy, 13900
        • Dip. Medicina Interna Ospedale degli Infermi di Biella
      • Brescia, Italy, 25123
        • Dipartimento di Ematologia Spedale Civili di Brescia
      • Brescia, Italy, 25123
        • Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia
      • Cagliari, Italy, 09126
        • Dipartimento di Ematologia Ospedale R. Binaghi
      • Caserta, Italy, 81100
        • Dip. Di Oncoematologia A.O. S.Anna e S. Sebastiano
      • Cremona, Italy, 26100
        • Dip. Di Ematologia A.O. Istituti Ospedalieri
      • Firenze, Italy, 50139
        • Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi
      • Genova, Italy, 10-1632
        • Dip. Di Ematologia A.O. Universitaria S. Martino
      • Genova, Italy, 10-1632
        • Dip. Di Medicina Interna A.O. Universitaria S. Martino
      • Giovanni Rotondo, Italy, 71013
        • Struttura di Ematologia, Dip. di Oncoematologia IRCCS Casa Sollievo della Sofferenza
      • Lecce, Italy, 73100
        • Dip. Di Ematologia Azienda Ospedaliera V. Fazzi
      • Milano, Italy, 20122
        • Centro Trapianti di Midollo Ospedale Maggiore Policlinico
      • Modena, Italy, 41124
        • Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria
      • Monza, Italy, 20052
        • Dip. Di Ematologia Azienda Ospedaliera S. Gerardo
      • Napoli, Italy, 80131
        • Dip. Di Oncoematologia A.O. Universitaria Federico II
      • Nocera Inferiore, Italy, 84014
        • Dip. Di Ematologia Presidio Ospedaliero Umberto I
      • Nuoro, Italy, 08100
        • Dip. Di Ematologia Ospedale S. Francesco
      • Padova, Italy, 35127
        • Dip. di Ematologia Azienda Ospedaliera
      • Parma, Italy, 43100
        • Dip. di Ematologia Azienda Ospedaliera
      • Perugia, Italy, 06156
        • Dip. Di Ematologia Azienda Ospedaliera - Osp. S. Maria della Misericordia
      • Pesaro, Italy, 61100
        • Dip. Di Ematologia Azienda Ospedaliera s. Salvatore
      • Potenza, Italy, 85100
        • Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo
      • Reggio Emilia, Italy, 42100
        • Servizio di Ematologia - Dip. di Oncologia Az. Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova
      • Revenna, Italy, 48100
        • Dip. Di Ematologia Ospedale S. Maria delle Croci
      • Roma, Italy, 00133
        • U. O. Ematologia Az. Ospedaliero-Universitaria Policlinico Tor Vergata
      • Roma, Italy, 00144
        • U.O.C Ematologia Ospedale S. Eugenio, Piazzale dell'Umanesimo
      • Roma, Italy, 00161
        • Dip. di Ematologia Policlinico Umberto I
      • Roma, Italy, 00168
        • U.O.C. Ematologia Policlinico Universitario Gemelli
      • Rossano, Italy, 87068
        • Dip. di Oncoematologia Ospedale Civile Giannettasio
      • Rovigo, Italy, 45100
        • Dip. di Oncoematologia Az. ULSS 18
      • Sassari, Italy, 07100
        • Dip. di Ematologia Policlinico Universitario di Sassari
      • Sienna, Italy, 53100
        • Divisione di Ematologia e Trapianti Spedali Riuniti
      • Torino, Italy, 10126
        • Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista
      • Torino, Italy, 10126
        • Dip. di Ematologia 2 A.O. Universitaria S.Giovanni Battista
      • Torino, Italy, 10128
        • Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I
      • Treviso, Italy, 31033
        • Unità Operativa Trasfusionale ed Immunologia Centro di riferimento per le malattie rare e centro regionale per le malattie del sangue Ospedale S. Giacomo Apostolo
      • Venezia, Italy, 30174
        • Ospedale Dell'Angelo USL12 - Venezia (Mestre)
      • Vicenza, Italy, 36100
        • Dip. Funzionale di Terapie Cellulari e Ematologia Azienda Sanitaria ULSS 6 - Osp. di Vicenza
      • Viterbo, Italy, 01100
        • Dip. Di Ematologia Ospedale di Belcolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by intermediate-1 and low risk MDS associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects achieving red blood cell (RBC) transfusion independence
Time Frame: 14 months
14 months
Number of subjects achieving an erythroid response
Time Frame: 14 months
14 months
Number of subjects achieving a cytogenetic response
Time Frame: 14 months
14 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Sante Cundari, PhD, MSc, Celgene s.r.l.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

June 30, 2013

Study Completion (ACTUAL)

June 30, 2013

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

May 4, 2011

First Posted (ESTIMATE)

May 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPMS- Celgene-MDS-ITA-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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