MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry
This study is ongoing, but not recruiting participants.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01347944
First received: October 29, 2010
Last updated: August 8, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | 210 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: lenalidomide
Patients who were prescribed Revlimid from 31October 2008 to present.
Other Name: Revlimid®
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:
- transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )
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
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: | August 8, 2012 |
| 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 Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Neoplasms Lenalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013