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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.
There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug | Patients who were prescribed Revlimid from 31October 2008 to present. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 14 months | |
| Duration of RBC transfusion independence | 14 months | |
| Duration of cytogenetic response |
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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
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Patients affected by intermediate-1 and low risk MDS associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present.
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| Name | Affiliation | Role |
|---|---|---|
| Sante Cundari, PhD, MSc | Celgene s.r.l. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento Onco - Ematologico Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo | Alessandria | 15121 | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29569278 | Background | 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. |
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| 14 months |
| Time to RBC transfusion independence | 14 months |
| Progression to acute myeloid leukemia (AML) | 14 months |
| Number of participants alive | 14 months |
| Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona |
| Ancona |
| 60100 |
| Italy |
| Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia | Asti | 14100 | Italy |
| Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari | Bari | 70124 | Italy |
| Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno | Belluno | 32100 | Italy |
| Ematologia A.O. Ospedale Riuniti di Bergamo | Bergamo | 24128 | Italy |
| Dip. Medicina Interna Ospedale degli Infermi di Biella | Biella | 13900 | Italy |
| Dipartimento di Ematologia Spedale Civili di Brescia | Brescia | 25123 | Italy |
| Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia | Brescia | 25123 | Italy |
| Dipartimento di Ematologia Ospedale R. Binaghi | Cagliari | 09126 | Italy |
| Dip. Di Oncoematologia A.O. S.Anna e S. Sebastiano | Caserta | 81100 | Italy |
| Dip. Di Ematologia A.O. Istituti Ospedalieri | Cremona | 26100 | Italy |
| Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi | Florence | 50139 | Italy |
| Dip. Di Ematologia A.O. Universitaria S. Martino | Genova | 10-1632 | Italy |
| Dip. Di Medicina Interna A.O. Universitaria S. Martino | Genova | 10-1632 | Italy |
| Dip. Di Ematologia Azienda Ospedaliera V. Fazzi | Lecce | 73100 | Italy |
| Centro Trapianti di Midollo Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria | Modena | 41124 | Italy |
| Dip. Di Ematologia Azienda Ospedaliera S. Gerardo | Monza | 20052 | Italy |
| Dip. Di Oncoematologia A.O. Universitaria Federico II | Naples | 80131 | Italy |
| Dip. Di Ematologia Presidio Ospedaliero Umberto I | Nocera Inferiore | 84014 | Italy |
| Dip. Di Ematologia Ospedale S. Francesco | Nuoro | 08100 | Italy |
| Dip. Di Ematologia Azienda Ospedaliera | Padova | 35127 | Italy |
| Dip. di Ematologia Azienda Ospedaliera | Parma | 43100 | Italy |
| Dip. Di Ematologia Azienda Ospedaliera - Osp. S. Maria della Misericordia | Perugia | 06156 | Italy |
| Dip. Di Ematologia Azienda Ospedaliera s. Salvatore | Pesaro | 61100 | Italy |
| Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo | Potenza | 85100 | Italy |
| Servizio di Ematologia - Dip. di Oncologia Az. Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova | Reggio Emilia | 42100 | Italy |
| Dip. Di Ematologia Ospedale S. Maria delle Croci | Revenna | 48100 | Italy |
| U. O. Ematologia Az. Ospedaliero-Universitaria Policlinico Tor Vergata | Roma | 00133 | Italy |
| U.O.C Ematologia Ospedale S. Eugenio, Piazzale dell'Umanesimo | Roma | 00144 | Italy |
| Dip. di Ematologia Policlinico Umberto I | Roma | 00161 | Italy |
| U.O.C. Ematologia Policlinico Universitario Gemelli | Roma | 00168 | Italy |
| Dip. di Oncoematologia Ospedale Civile Giannettasio | Rossano | 87068 | Italy |
| Dip. di Oncoematologia Az. ULSS 18 | Rovigo | 45100 | Italy |
| Struttura di Ematologia, Dip. di Oncoematologia IRCCS Casa Sollievo della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| Dip. di Ematologia Policlinico Universitario di Sassari | Sassari | 07100 | Italy |
| Divisione di Ematologia e Trapianti Spedali Riuniti | Siena | 53100 | Italy |
| Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista | Torino | 10126 | Italy |
| Dip. di Ematologia 2 A.O. Universitaria S.Giovanni Battista | Torino | 10126 | Italy |
| Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I | Torino | 10128 | 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 | 31033 | Italy |
| Ospedale Dell'Angelo USL12 - Venezia (Mestre) | Venezia | 30174 | Italy |
| Dip. Funzionale di Terapie Cellulari e Ematologia Azienda Sanitaria ULSS 6 - Osp. di Vicenza | Vicenza | 36100 | Italy |
| Dip. Di Ematologia Ospedale di Belcolle | Viterbo | 01100 | Italy |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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