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NCT01347944 Clinical Trial

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

Myelodysplastic Syndrome Clinical Trial

— MORE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01347944
Other study ID # NIPMS- Celgene-MDS-ITA-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date June 30, 2013

Study information
Verified date November 2019
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 149
Est. completion date June 30, 2013
Est. primary completion date June 30, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• lenalidomide
Patients who were prescribed Revlimid from 31October 2008 to present.

Locations
Country Name City State
Italy Dipartimento Onco - Ematologico Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo Alessandria
Italy Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona Ancona
Italy Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia Asti
Italy Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari Bari
Italy Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno Belluno
Italy Ematologia A.O. Ospedale Riuniti di Bergamo Bergamo
Italy Dip. Medicina Interna Ospedale degli Infermi di Biella Biella
Italy Dipartimento di Ematologia Spedale Civili di Brescia Brescia
Italy Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia Brescia
Italy Dipartimento di Ematologia Ospedale R. Binaghi Cagliari
Italy Dip. Di Oncoematologia A.O. S.Anna e S. Sebastiano Caserta
Italy Dip. Di Ematologia A.O. Istituti Ospedalieri Cremona
Italy Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi Firenze
Italy Dip. Di Ematologia A.O. Universitaria S. Martino Genova
Italy Dip. Di Medicina Interna A.O. Universitaria S. Martino Genova
Italy Struttura di Ematologia, Dip. di Oncoematologia IRCCS Casa Sollievo della Sofferenza Giovanni Rotondo
Italy Dip. Di Ematologia Azienda Ospedaliera V. Fazzi Lecce
Italy Centro Trapianti di Midollo Ospedale Maggiore Policlinico Milano
Italy Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria Modena
Italy Dip. Di Ematologia Azienda Ospedaliera S. Gerardo Monza
Italy Dip. Di Oncoematologia A.O. Universitaria Federico II Napoli
Italy Dip. Di Ematologia Presidio Ospedaliero Umberto I Nocera Inferiore
Italy Dip. Di Ematologia Ospedale S. Francesco Nuoro
Italy Dip. Di Ematologia Azienda Ospedaliera Padova
Italy Dip. di Ematologia Azienda Ospedaliera Parma
Italy Dip. Di Ematologia Azienda Ospedaliera - Osp. S. Maria della Misericordia Perugia
Italy Dip. Di Ematologia Azienda Ospedaliera s. Salvatore Pesaro
Italy Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo Potenza
Italy Servizio di Ematologia - Dip. di Oncologia Az. Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova Reggio Emilia
Italy Dip. Di Ematologia Ospedale S. Maria delle Croci Revenna
Italy Dip. di Ematologia Policlinico Umberto I Roma
Italy U. O. Ematologia Az. Ospedaliero-Universitaria Policlinico Tor Vergata Roma
Italy U.O.C Ematologia Ospedale S. Eugenio, Piazzale dell'Umanesimo Roma
Italy U.O.C. Ematologia Policlinico Universitario Gemelli Roma
Italy Dip. di Oncoematologia Ospedale Civile Giannettasio Rossano
Italy Dip. di Oncoematologia Az. ULSS 18 Rovigo
Italy Dip. di Ematologia Policlinico Universitario di Sassari Sassari
Italy Divisione di Ematologia e Trapianti Spedali Riuniti Sienna
Italy Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista Torino
Italy Dip. di Ematologia 2 A.O. Universitaria S.Giovanni Battista Torino
Italy Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I Torino
Italy 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 Ospedale Dell'Angelo USL12 - Venezia (Mestre) Venezia
Italy Dip. Funzionale di Terapie Cellulari e Ematologia Azienda Sanitaria ULSS 6 - Osp. di Vicenza Vicenza
Italy Dip. Di Ematologia Ospedale di Belcolle Viterbo

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of subjects achieving red blood cell (RBC) transfusion independence 14 months
Primary Number of subjects achieving an erythroid response 14 months
Primary Number of subjects achieving a cytogenetic response 14 months
Secondary Number of participants with adverse events 14 months
Secondary Duration of RBC transfusion independence 14 months
Secondary Duration of cytogenetic response 14 months
Secondary Time to RBC transfusion independence 14 months
Secondary Progression to acute myeloid leukemia (AML) 14 months
Secondary Number of participants alive 14 months
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