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

NCT01347944 | Completed DMC

• 1 other identifier: NIPMS- Celgene-MDS-ITA-002
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 45

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.

Conditions

Myelodysplastic Syndrome

Keywords

MORE; Monitoring Revlimid; Myelodysplastic Syndrome; Transfusion-dependent anemia; 5q deletion; lenalidomide

Outcome Measures

Primary Outcomes (3)

• Number of subjects achieving red blood cell (RBC) transfusion independence

  14 months

• Number of subjects achieving an erythroid response

  14 months

• Number of subjects achieving a cytogenetic response

  14 months

Secondary Outcomes (6)

• Number of participants with adverse events

  14 months

• Duration of RBC transfusion independence

  14 months

• Duration of cytogenetic response

  14 months

• Time to RBC transfusion independence

  14 months

• Progression to acute myeloid leukemia (AML)

  14 months

Interventions

lenalidomide DRUG

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

Also known as: Revlimid®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• intermediate 1 and low risk MDS patients associated with:
• transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )
• q31-33 deletion isolated or associated to other chromosomal abnormalities.

You may not qualify if:

• patients with serum creatinine \> 2.5mg/dl
• child bearing potential females who do not use adequate contraceptive methods

Sponsors & Collaborators

• Celgene: lead

Study Sites (45)

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

Alessandria, 15121, Italy

Location

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

Ancona, 60100, Italy

Location

Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia

Asti, 14100, Italy

Location

Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari

Bari, 70124, Italy

Location

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

Belluno, 32100, Italy

Location

Ematologia A.O. Ospedale Riuniti di Bergamo

Bergamo, 24128, Italy

Location

Dip. Medicina Interna Ospedale degli Infermi di Biella

Biella, 13900, Italy

Location

Dipartimento di Ematologia Spedale Civili di Brescia

Brescia, 25123, Italy

Location

Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia

Brescia, 25123, Italy

Location

Dipartimento di Ematologia Ospedale R. Binaghi

Cagliari, 09126, Italy

Location

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

Caserta, 81100, Italy

Location

Dip. Di Ematologia A.O. Istituti Ospedalieri

Cremona, 26100, Italy

Location

Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi

Florence, 50139, Italy

Location

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

Genova, 10-1632, Italy

Location

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

Genova, 10-1632, Italy

Location

Dip. Di Ematologia Azienda Ospedaliera V. Fazzi

Lecce, 73100, Italy

Location

Centro Trapianti di Midollo Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria

Modena, 41124, Italy

Location

Dip. Di Ematologia Azienda Ospedaliera S. Gerardo

Monza, 20052, Italy

Location

Dip. Di Oncoematologia A.O. Universitaria Federico II

Napoli, 80131, Italy

Location

Dip. Di Ematologia Presidio Ospedaliero Umberto I

Nocera Inferiore, 84014, Italy

Location

Dip. Di Ematologia Ospedale S. Francesco

Nuoro, 08100, Italy

Location

Dip. Di Ematologia Azienda Ospedaliera

Padua, 35127, Italy

Location

Dip. di Ematologia Azienda Ospedaliera

Parma, 43100, Italy

Location

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

Perugia, 06156, Italy

Location

Dip. Di Ematologia Azienda Ospedaliera s. Salvatore

Pesaro, 61100, Italy

Location

Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo

Potenza, 85100, Italy

Location

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

Reggio Emilia, 42100, Italy

Location

Dip. Di Ematologia Ospedale S. Maria delle Croci

Revenna, 48100, Italy

Location

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

Roma, 00133, Italy

Location

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

Roma, 00144, Italy

Location

Dip. di Ematologia Policlinico Umberto I

Roma, 00161, Italy

Location

U.O.C. Ematologia Policlinico Universitario Gemelli

Roma, 00168, Italy

Location

Dip. di Oncoematologia Ospedale Civile Giannettasio

Rossano, 87068, Italy

Location

Dip. di Oncoematologia Az. ULSS 18

Rovigo, 45100, Italy

Location

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

San Giovanni Rotondo, 71013, Italy

Location

Dip. di Ematologia Policlinico Universitario di Sassari

Sassari, 07100, Italy

Location

Divisione di Ematologia e Trapianti Spedali Riuniti

Siena, 53100, Italy

Location

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

Torino, 10126, Italy

Location

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

Torino, 10126, Italy

Location

Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I

Torino, 10128, Italy

Location

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, 31033, Italy

Location

Ospedale Dell'Angelo USL12 - Venezia (Mestre)

Venezia, 30174, Italy

Location

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

Vicenza, 36100, Italy

Location

Dip. Di Ematologia Ospedale di Belcolle

Viterbo, 01100, Italy

Location

Related 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.

  PMID: 29569278 BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sante Cundari, PhD, MSc

  Celgene s.r.l.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: May 5, 2011
• Study Start: January 1, 2011
• Primary Completion: June 30, 2013
• Study Completion: June 30, 2013
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

IT (45)