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

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ClinicalTrials.gov Identifier: NCT01347944
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : March 24, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Myelodysplastic Syndrome Drug: lenalidomide

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

Study Design

Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Official 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
Study Start Date : January 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Groups and Cohorts

Intervention Details:
    Drug: lenalidomide
    Patients who were prescribed Revlimid from 31October 2008 to present.
    Other Name: Revlimid®

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347944

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

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01347944     History of Changes
Other Study ID Numbers: NIPMS- Celgene-MDS-ITA-002
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016

Keywords provided by Celgene Corporation:
Monitoring Revlimid
Myelodysplastic Syndrome
Transfusion-dependent anemia
5q deletion

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents