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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01347944
First received: October 29, 2010
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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 Intervention
Myelodysplastic Syndrome
Drug: lenalidomide

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of subjects achieving red blood cell (RBC) transfusion independence [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of subjects achieving an erythroid response [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of subjects achieving a cytogenetic response [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
  • Duration of RBC transfusion independence [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Duration of cytogenetic response [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Time to RBC transfusion independence [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Progression to acute myeloid leukemia (AML) [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Number of participants alive [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lenalidomide
    Patients who were prescribed Revlimid from 31October 2008 to present.
    Other Name: Revlimid®
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347944

Locations
Italy
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
Dip. di Ematologia Policlinico Umberto I
Roma, Italy, 00161
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
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 2 A.O. Universitaria S.Giovanni Battista
Torino, Italy, 10126
Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I
Torino, Italy, 10128
Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista
Torino, Italy, 10126
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
Investigators
Study Director: Sante Cundari, PhD, MSc Celgene s.r.l.
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01347944     History of Changes
Other Study ID Numbers: NIPMS- Celgene-MDS-ITA-002
Study First Received: October 29, 2010
Last Updated: June 4, 2013
Health Authority: Italy: National Bioethics Committee

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Disease
Pathologic Processes
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014