Clinical trial NCT01347944: MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Keywords: MORE
Monitoring Revlimid
Myelodysplastic Syndrome
Transfusion-dependent anemia
5q deletion
lenalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Eligibility 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

Primary outcomes:
measure: Number of subjects achieving red blood cell (RBC) transfusion independence
timeFrame: 14 months
measure: Number of subjects achieving an erythroid response
timeFrame: 14 months
measure: Number of subjects achieving a cytogenetic response
timeFrame: 14 months
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 14 months
measure: Duration of RBC transfusion independence
timeFrame: 14 months
measure: Duration of cytogenetic response
timeFrame: 14 months
measure: Time to RBC transfusion independence
timeFrame: 14 months
measure: Progression to acute myeloid leukemia (AML)
timeFrame: 14 months
measure: Number of participants alive
timeFrame: 14 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Dipartimento Onco - Ematologico Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Asti
country: Italy
facility: Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia
city: Bari
country: Italy
facility: Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari
city: Belluno
country: Italy
facility: Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno
city: Bergamo
country: Italy
facility: Ematologia A.O. Ospedale Riuniti di Bergamo
city: Biella
country: Italy
facility: Dip. Medicina Interna Ospedale degli Infermi di Biella
city: Brescia
country: Italy
facility: Dipartimento di Ematologia Spedale Civili di Brescia
city: Brescia
country: Italy
facility: Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia
city: Cagliari
country: Italy
facility: Dipartimento di Ematologia Ospedale R. Binaghi
city: Caserta
country: Italy
facility: Dip. Di Oncoematologia A.O. S.Anna e S. Sebastiano
city: Cremona
country: Italy
facility: Dip. Di Ematologia A.O. Istituti Ospedalieri
city: Firenze
country: Italy
facility: Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi
city: Genova
country: Italy
facility: Dip. Di Ematologia A.O. Universitaria S. Martino
city: Genova
country: Italy
facility: Dip. Di Medicina Interna A.O. Universitaria S. Martino
city: Giovanni Rotondo
country: Italy
facility: Struttura di Ematologia, Dip. di Oncoematologia IRCCS Casa Sollievo della Sofferenza
city: Lecce
country: Italy
facility: Dip. Di Ematologia Azienda Ospedaliera V. Fazzi
city: Milano
country: Italy
facility: Centro Trapianti di Midollo Ospedale Maggiore Policlinico
city: Modena
country: Italy
facility: Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria
city: Monza
country: Italy
facility: Dip. Di Ematologia Azienda Ospedaliera S. Gerardo
city: Napoli
country: Italy
facility: Dip. Di Oncoematologia A.O. Universitaria Federico II
city: Nocera Inferiore
country: Italy
facility: Dip. Di Ematologia Presidio Ospedaliero Umberto I
city: Nuoro
country: Italy
facility: Dip. Di Ematologia Ospedale S. Francesco
city: Padova
country: Italy
facility: Dip. Di Ematologia Azienda Ospedaliera
city: Parma
country: Italy
facility: Dip. di Ematologia Azienda Ospedaliera
city: Perugia
country: Italy
facility: Dip. Di Ematologia Azienda Ospedaliera - Osp. S. Maria della Misericordia
city: Pesaro
country: Italy
facility: Dip. Di Ematologia Azienda Ospedaliera s. Salvatore
city: Potenza
country: Italy
facility: Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo
city: Reggio Emilia
country: Italy
facility: Servizio di Ematologia - Dip. di Oncologia Az. Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova
city: Revenna
country: Italy
facility: Dip. Di Ematologia Ospedale S. Maria delle Croci
city: Roma
country: Italy
facility: U. O. Ematologia Az. Ospedaliero-Universitaria Policlinico Tor Vergata
city: Roma
country: Italy
facility: U.O.C Ematologia Ospedale S. Eugenio, Piazzale dell'Umanesimo
city: Roma
country: Italy
facility: Dip. di Ematologia Policlinico Umberto I
city: Roma
country: Italy
facility: U.O.C. Ematologia Policlinico Universitario Gemelli
city: Rossano
country: Italy
facility: Dip. di Oncoematologia Ospedale Civile Giannettasio
city: Rovigo
country: Italy
facility: Dip. di Oncoematologia Az. ULSS 18
city: Sassari
country: Italy
facility: Dip. di Ematologia Policlinico Universitario di Sassari
city: Sienna
country: Italy
facility: Divisione di Ematologia e Trapianti Spedali Riuniti
city: Torino
country: Italy
facility: Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista
city: Torino
country: Italy
facility: Dip. di Ematologia 2 A.O. Universitaria S.Giovanni Battista
city: Torino
country: Italy
facility: Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I
city: Treviso
country: Italy
facility: Unità Operativa Trasfusionale ed Immunologia Centro di riferimento per le malattie rare e centro regionale per le malattie del sangue Ospedale S. Giacomo Apostolo
city: Venezia
country: Italy
facility: Ospedale Dell'Angelo USL12 - Venezia (Mestre)
city: Vicenza
country: Italy
facility: Dip. Funzionale di Terapie Cellulari e Ematologia Azienda Sanitaria ULSS 6 - Osp. di Vicenza
city: Viterbo
country: Italy
facility: Dip. Di Ematologia Ospedale di Belcolle
Study officials:
affiliation: Celgene s.r.l.
name: Sante Cundari, PhD, MSc
role: STUDY_DIRECTOR
References:
citation: 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.