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

NCT ID: NCT01347944

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2013-06-30

Brief Summary

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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

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

Conditions

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Myelodysplastic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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lenalidomide

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

Intervention Type DRUG

Other Intervention Names

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Revlimid®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sante Cundari, PhD, MSc

Role: STUDY_DIRECTOR

Celgene s.r.l.

Locations

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

Alessandria, , Italy

Site Status

Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, , Italy

Site Status

Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia

Asti, , Italy

Site Status

Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari

Bari, , Italy

Site Status

Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno

Belluno, , Italy

Site Status

Ematologia A.O. Ospedale Riuniti di Bergamo

Bergamo, , Italy

Site Status

Dip. Medicina Interna Ospedale degli Infermi di Biella

Biella, , Italy

Site Status

Dipartimento di Ematologia Spedale Civili di Brescia

Brescia, , Italy

Site Status

Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia

Brescia, , Italy

Site Status

Dipartimento di Ematologia Ospedale R. Binaghi

Cagliari, , Italy

Site Status

Dip. Di Oncoematologia A.O. S.Anna e S. Sebastiano

Caserta, , Italy

Site Status

Dip. Di Ematologia A.O. Istituti Ospedalieri

Cremona, , Italy

Site Status

Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi

Florence, , Italy

Site Status

Dip. Di Ematologia A.O. Universitaria S. Martino

Genova, , Italy

Site Status

Dip. Di Medicina Interna A.O. Universitaria S. Martino

Genova, , Italy

Site Status

Dip. Di Ematologia Azienda Ospedaliera V. Fazzi

Lecce, , Italy

Site Status

Centro Trapianti di Midollo Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria

Modena, , Italy

Site Status

Dip. Di Ematologia Azienda Ospedaliera S. Gerardo

Monza, , Italy

Site Status

Dip. Di Oncoematologia A.O. Universitaria Federico II

Napoli, , Italy

Site Status

Dip. Di Ematologia Presidio Ospedaliero Umberto I

Nocera Inferiore, , Italy

Site Status

Dip. Di Ematologia Ospedale S. Francesco

Nuoro, , Italy

Site Status

Dip. Di Ematologia Azienda Ospedaliera

Padua, , Italy

Site Status

Dip. di Ematologia Azienda Ospedaliera

Parma, , Italy

Site Status

Dip. Di Ematologia Azienda Ospedaliera - Osp. S. Maria della Misericordia

Perugia, , Italy

Site Status

Dip. Di Ematologia Azienda Ospedaliera s. Salvatore

Pesaro, , Italy

Site Status

Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo

Potenza, , Italy

Site Status

Servizio di Ematologia - Dip. di Oncologia Az. Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova

Reggio Emilia, , Italy

Site Status

Dip. Di Ematologia Ospedale S. Maria delle Croci

Revenna, , Italy

Site Status

U. O. Ematologia Az. Ospedaliero-Universitaria Policlinico Tor Vergata

Roma, , Italy

Site Status

U.O.C Ematologia Ospedale S. Eugenio, Piazzale dell'Umanesimo

Roma, , Italy

Site Status

Dip. di Ematologia Policlinico Umberto I

Roma, , Italy

Site Status

U.O.C. Ematologia Policlinico Universitario Gemelli

Roma, , Italy

Site Status

Dip. di Oncoematologia Ospedale Civile Giannettasio

Rossano, , Italy

Site Status

Dip. di Oncoematologia Az. ULSS 18

Rovigo, , Italy

Site Status

Struttura di Ematologia, Dip. di Oncoematologia IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Dip. di Ematologia Policlinico Universitario di Sassari

Sassari, , Italy

Site Status

Divisione di Ematologia e Trapianti Spedali Riuniti

Siena, , Italy

Site Status

Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista

Torino, , Italy

Site Status

Dip. di Ematologia 2 A.O. Universitaria S.Giovanni Battista

Torino, , Italy

Site Status

Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I

Torino, , Italy

Site Status

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

Site Status

Ospedale Dell'Angelo USL12 - Venezia (Mestre)

Venezia, , Italy

Site Status

Dip. Funzionale di Terapie Cellulari e Ematologia Azienda Sanitaria ULSS 6 - Osp. di Vicenza

Vicenza, , Italy

Site Status

Dip. Di Ematologia Ospedale di Belcolle

Viterbo, , Italy

Site Status

Countries

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Italy

References

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Arcioni F, Roncadori A, Di Battista V, Tura S, Covezzoli A, Cundari S, Mecucci C; MORE Study Centres. Lenalidomide treatment of myelodysplastic syndromes with chromosome 5q deletion: Results from the National Registry of the Italian Drug Agency. Eur J Haematol. 2018 Jul;101(1):78-85. doi: 10.1111/ejh.13067. Epub 2018 May 22.

Reference Type BACKGROUND
PMID: 29569278 (View on PubMed)

Other Identifiers

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NIPMS- Celgene-MDS-ITA-002

Identifier Type: -

Identifier Source: org_study_id

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