Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)].
The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide Population | Patients with transfusion-dependent, low- or intermediate (int)-1risk MDS and isolated del (5q) who receive at least 1 dose of lenalidomide after 15th June 2007 and have been followed up for on the registry for 3 years or until death/consent withdrawal |
| |
| Background Population | All MDS patients who have been diagnosed on 15th June 2007 or later, have never been exposed to lenalidomide and have been followed up on the registry for 3 years or until death/consent withdrawal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ascertain the Disease Progression to AML (through calculation of product limit estimators and incidence rates) for those with transfusion dependent Low to Intermediate 1 risk MDS del 5 q and have been treated with Revlimid | Incidence, as well as the attributable risk (AR) and AR percent (%). Progressive Disease criteria includes increasing monoclonal paraprotein levels, bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. | Up to 3 years |
| Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide | Number of MDS participants who survive | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival for patients with transfusion-dependent low to intermediate 1 risk MDS and isolated del (5q) and who have been treated with Lenalidomide | Number of MDS participants who survive who have never been treated with Lenalidomide | Up to 3 years |
| Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who have received at least 1 dose of any treatment or treatment modality after the patient signs the informed consent form
For each population 3 datasets will be described and will form the basis of subsequent analyses:
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Centre City | New Jersey | ZIP CODE | United States | ||
| Local Institution - 0002 |
Not provided
Not provided
Not provided
|
Type, frequency, severity of advere events and relationship of adverse events to Lenalidomide. An adverse ecent is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment, ie, any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product |
| Up to 3 years |
| Evaluate risk factors associated with progression of AML | Employ Cox proportional hazards models among MDS patients included in the primary population who have been treated with lenalidomide | Up to 3 years |
| Clinical practice | Provide insight into treatment regimens and therapy sequence in clinical practice as they relate to clinical outcomes (response, overall survival, progression-free survival) in patients in MDS participants | Up to 3 years |
| Centre City |
| New Jersey |
| ZIP CODE |
| United States |
| Local Institution - Belgium | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Denmark | No City Provided | New Jersey | 00000 | United States |
| Local Institution - France | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Germany | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Greece | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Italy | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Luxembourg | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Norway | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Spain | No City Provided | New Jersey | 00000 | United States |
| Local Institution - Sweden | No City Provided | New Jersey | 00000 | United States |
| Local Institution - UK | No City Provided | New Jersey | 00000 | United States |
| AZ Klina | Brasschaat | B -2930 | Belgium |
| AZ Sint Jan | Bruges | B-8000 | Belgium |
| GHdCharleroi | Charleroi | B-6000 | Belgium |
| Jessa Ziekenhuis | Hasselt | B-35000 | Belgium |
| CHR Citadelle | Liège | 4000 | Belgium |
| CHU Vésale | Montigny-le-Tilleul | B-6110 | Belgium |
| Clinique Saint-Pierre Ottignie | Ottignies | 01340 | Belgium |
| Aalborg Sygehus, Dept of Hematology | Aalborg | DK-9000 | Denmark |
| Århus University Hospital | Aarhus | DK-8000 | Denmark |
| Herlev Hospital | Herlev | 2730 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Rokslide Hospital | Roskilde | 4000 | Denmark |
| Hopital de L'archet I | Nice | Alpes-Maritimes | 6202 | France |
| Institut Paoli Calmettes | Marseille | Bouches-du-Rhône | 13273 | France |
| CHU Haut-Lévêque | Pessac | Gironde | 33604 | France |
| CHU Hôtel Dieu | Nantes | Loire-Atlantique | 44093 | France |
| CHU Hôtel Dieu | Angers | 49933 | France |
| Centre Hospitalier D'Avignon - Hopital Henri Duffaut | Avignon | 84000 | France |
| CH Chalon/Saone William Morey | Chalon-sur-Saône | 71100 | France |
| CHU Grenoble | La Tronche | 38700 | France |
| CHRU De Lille - Hôpital Claude - Rue Michel Polonovski | Lille | 59037 | France |
| Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt | Limoges | 87042 | France |
| CHU Hôtel Dieu - Place A Ricordeau | Nantes | 44000 | France |
| Hôpital St Louis | Paris | 75475 | France |
| Centre Hospitalier Lyon-SUD [U | Pierre-Bénite | 69310 | France |
| Hopital de Hautepierre CHRU de Strasbourg | Strasbourg | 67091 | France |
| Hopital Purpan-Place du Dr. Baylac | Toulouse | 31059 | France |
| CHU Bretonneau | Tours | 37000 | France |
| CHU Nancy Brabois Adultes - 58 Allee dy morvan | Vandœuvre-lès-Nancy | 54500 | France |
| Onkologische Schwerpunktpraxis Bielefeld | Bielefeld | 33604 | Germany |
| Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center | Chemnitz | 09113 | Germany |
| Gemeinschaftspraxis Hämatologie-Onkologie | Dresden | 01307 | Germany |
| Universitätsklinik Carl-Gustav | Dresden | 01307 | Germany |
| HELIOS St. Johannes Klinik | Duisburg | 47166 | Germany |
| Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie | Düsseldorf | 40225 | Germany |
| Marien Hospital Düsseldorf | Düsseldorf | 40479 | Germany |
| St Antonius Hospital (SAH) | Eschweiler | 52249 | Germany |
| Kreiskrankenhaus St. Elisabeth - Von Werth-Str. | Grevenbroich | 41515 | Germany |
| Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort | Hamburg | 20095 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Institut für Versorgungsforschung in der Onkologie | Koblenz | 56068 | Germany |
| InVO Institut fur Versorgungsforschung | Koblenz | 56068 | Germany |
| Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach | Lebach | 66822 | Germany |
| Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig | Leipzig | 04103 | Germany |
| III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim | Mannheim | 68167 | Germany |
| Gesellschaft für Medizinische | Mönchengladbach | 41239 | Germany |
| MLL Münchner Leukämielabor GmbH | München | 81377 | Germany |
| III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München | München | 81675 | Germany |
| Gemeinschaftspraxis für Hämatologie und Onkologie | Münster | 48149 | Germany |
| Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen | Tübingen | 72076 | Germany |
| Klinik für Innere Medizin III | Ulm | 89081 | Germany |
| Gemeinschaftspraxis für Hämatologie und Onkologie | Westerstede | 26655 | Germany |
| Rems-Murr-Klinikum Winnenden | Winnenden | 71364 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg | Würzburg | 97080 | Germany |
| University Hospital of Alexandroupolis | Alexandroupoli | GR-68100 | Greece |
| General Hospital of Athens - LAIKO | Athens | 11527 | Greece |
| University General Hospital | Athens | 12461 | Greece |
| Georgios Gennimatos General Hospital | Athens | GR 11527 | Greece |
| University Hospital Of Herakli | Herakleion - Crete | 71110 | Greece |
| University General Hospital of Ioannina | Ioannina | 45500 | Greece |
| University General Hospital of Larissa | Larissa | 4110 | Greece |
| University General Hospital of Patras | Pátrai | 26504 | Greece |
| G. Papanikolaou General Hospital | Thessaloniki | 57010 | Greece |
| Irccs Crob | Rionero in Vulture | Potenza | 85028 | Italy |
| Ospedale di Castelfranco Venet | Castelfranco Veneto | Treviso | 31033 | Italy |
| AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi | Ancona | 60020 | Italy |
| U.O Ematologia con Trapianto | Bari | 70124 | Italy |
| Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS | Bergamo | 1 24127 | Italy |
| Policlinico S.Orsola Malpighi, AOU di Bologna | Bologna | 40138 | Italy |
| AO Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Policlinico di Catania | Catania | 95124 | Italy |
| AOU Careggi | Florence | 50134 | Italy |
| U.O .C di Oncoematologia | Mirano | 76 30035 | Italy |
| Ospedale S. Luigi Gonzaga | Orbassano | 10043 | Italy |
| Azienda ospedaliero-universita | Parma | 43126 | Italy |
| Azienda Ospedaliera di Perugia | Perugia | 106100 | Italy |
| Ospedale Civile Santo Spirito | Pescara | 65124 | Italy |
| Arcispedale S.Maria Nuova | Reggio Emilia | 42123 | Italy |
| U.O Ematologia Azienda Ospedaliera | Regio Calabria | 89100 | Italy |
| Univesita La Sapienza | Roma | 00161 | Italy |
| AOU Policlinico Tor Vergata, Università Roma Tor Vergata | Roma | 81 00133 | Italy |
| Presidio Ospedaliero "A. Torto | Salerno | 84016 | Italy |
| Azienda Ospedaliera Universitaria di Sassari | Sassari | 07100 | Italy |
| A.O. Citta' della Salute e del | Torino | 10126 | Italy |
| Policlinico "G.B. Rossi" Verona | Veneto | 37100 | Italy |
| Centre Hospitalier de Luxembourg | Luxembourg | 01210 | Luxembourg |
| Haukeland Sykehus | Bergen | N-5021 | Norway |
| Hospital Universitario de Gran Canaria Servicio de Hematología y | Las Palmas de Gran Canaria | Canary Islands | 35010 | Spain |
| H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología | Santander | Cantabria | 39008 | Spain |
| Hospital costa del sol | Marbella | Málaga | 29603 | Spain |
| H.U. Ribera de Alzira | Alzira | 46600 | Spain |
| Hospital de Cruces | Barakaldo | 48903 | Spain |
| Hospital del Mar,Hematologia Hemotheropia | Barcelona | 08003 | Spain |
| H. Clinic de Barcelona | Barcelona | 08036 | Spain |
| Pauc Tauli | Barcelona | 08208 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08835 | Spain |
| Instit Catalia D'Oncologia | Barcelona | 08916 | Spain |
| Hospital Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Josep Trueta (ICO Girona) | Girona | 17007 | Spain |
| Hospital Virgen de Las Nieves | Granada | 18014 | Spain |
| Department of Hematology, Hospital Duran i Reynals | LLobregat | 08908 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hopsital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario fundacion Jiminez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octobre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| H Universitario Puera de Hierro | Madrid | 28222 | Spain |
| Hospital Son Espaces | Mallorca | 07120 | Spain |
| Hospital Universitario central de Asturias | Oviedo | 33011 | Spain |
| Univesity Hospital de Salamanca | Salamenca | 37007 | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Virgen Macarena | Seville | 41009 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Hopsital Nuestra Senora de Valme | Seville | 41014 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospiral Universitario de la Fe | Valencia | 46026 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| Länssjukhuset Kalmar | Kalmar | 391 85 | Sweden |
| Lund University Hospital - Lasarettsgatan 23 | Lund | 22185 | Sweden |
| Karolinska University Hopsital | Stockholm | 141 86 | Sweden |
| Maidstone Hospital | Maidstone | Kent | ME16 9QQ | United Kingdom |
| Aberdeen Royal Infirmary - Foresterhill Road | Aberdeen | AB25 2ZN | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Pilgrim Hospital | Boston | PE21 9QS | United Kingdom |
| Monkton, Wishaw and Hairmyres Hospitals | East Kilbride | G75 8RG | United Kingdom |
| Broomfield Hospital - Mid-Essex Hospitals NHS Trust | Essex | CM1 7ET | United Kingdom |
| Basildon and Thurrock Hospitals | Essex | SS16 5NL | United Kingdom |
| Northwick Park Hospital | Harrow | HA1 3UJ | United Kingdom |
| Lincoln county Hospital | Lincoln | LN2 5QY | United Kingdom |
| Aintree Hospital - Longmoor Lane | Liverpool | L9 7AL | United Kingdom |
| University Hospital South Manc | Manchester | M23 9LT | United Kingdom |
| Royal Oldham Hospital | Oldham | OL1 2JH | United Kingdom |
| Radcliffe Hospitals and University - Headley Way, Headington | Oxford | OX3 9DU | United Kingdom |
| Great Western Hospital | Swindon | SN3 6BB | United Kingdom |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided