Spots Global Cancer Trial Database for Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
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Trial Identification
Brief Title: Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
Official Title: A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.
Study ID: NCT02279654
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 0001, Centre City, New Jersey, United States
Local Institution - 0002, Centre City, New Jersey, United States
Local Institution - Belgium, No City Provided, New Jersey, United States
Local Institution - Denmark, No City Provided, New Jersey, United States
Local Institution - France, No City Provided, New Jersey, United States
Local Institution - Germany, No City Provided, New Jersey, United States
Local Institution - Greece, No City Provided, New Jersey, United States
Local Institution - Italy, No City Provided, New Jersey, United States
Local Institution - Luxembourg, No City Provided, New Jersey, United States
Local Institution - Norway, No City Provided, New Jersey, United States
Local Institution - Spain, No City Provided, New Jersey, United States
Local Institution - Sweden, No City Provided, New Jersey, United States
Local Institution - UK, No City Provided, New Jersey, United States
AZ Klina, Brasschaat, , Belgium
AZ Sint Jan, Brugge, , Belgium
GHdCharleroi, Charleroi, , Belgium
Jessa Ziekenhuis, Hasselt, , Belgium
CHR Citadelle, Liège, , Belgium
CHU Vésale, Montigny- le- tilleul, , Belgium
Clinique Saint-Pierre Ottignie, Ottignies, , Belgium
Aalborg Sygehus, Dept of Hematology, Aalborg, , Denmark
Århus University Hospital, Aarhus, , Denmark
Herlev Hospital, Herlev, , Denmark
Odense University Hospital, Odense, , Denmark
Rokslide Hospital, Roskilde, , Denmark
Hopital de L'archet I, Nice, Alpes-Maritimes, France
Institut Paoli Calmettes, Marseille, Bouches-du-Rhône, France
CHU Haut-Lévêque, Pessac, Gironde, France
CHU Hôtel Dieu, Nantes cedex 01, Loire-Atlantique, France
CHU Hôtel Dieu, Angers, , France
Centre Hospitalier D'Avignon - Hopital Henri Duffaut, Avignon, , France
CH Chalon/Saone William Morey, Chalon Sur Saone, , France
CHU Grenoble, La Tronche, , France
CHRU De Lille - Hôpital Claude - Rue Michel Polonovski, Lille, , France
Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt, Limoges, , France
CHU Hôtel Dieu - Place A Ricordeau, Nantes, , France
Hôpital St Louis, Paris, , France
Centre Hospitalier Lyon-SUD [U, Pierre- Bénite, , France
Hopital de Hautepierre CHRU de Strasbourg, Strasbourg, , France
Hopital Purpan-Place du Dr. Baylac, Toulouse, , France
CHU Bretonneau, Tours, , France
CHU Nancy Brabois Adultes - 58 Allee dy morvan, Vandoeuvre les Nancy, , France
Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, , Germany
Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center, Chemnitz, , Germany
Gemeinschaftspraxis Hämatologie-Onkologie, Dresden, , Germany
Universitätsklinik Carl-Gustav, Dresden, , Germany
HELIOS St. Johannes Klinik, Duisburg, , Germany
Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie, Düsseldorf, , Germany
Marien Hospital Düsseldorf, Düsseldorf, , Germany
St Antonius Hospital (SAH), Eschweiler, , Germany
Kreiskrankenhaus St. Elisabeth - Von Werth-Str., Grevenbroich, , Germany
Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Institut für Versorgungsforschung in der Onkologie, Koblenz, , Germany
InVO Institut fur Versorgungsforschung, Koblenz, , Germany
Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach, Lebach, , Germany
Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig, Leipzig, , Germany
III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim, Mannheim, , Germany
Gesellschaft für Medizinische, Mönchengladbach, , Germany
MLL Münchner Leukämielabor GmbH, München, , Germany
III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, München, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, Münster, , Germany
Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen, Tübingen, , Germany
Klinik für Innere Medizin III, Ulm, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, Westerstede, , Germany
Rems-Murr-Klinikum Winnenden, Winnenden, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg, Würzburg, , Germany
University Hospital of Alexandroupolis, Alexandroupolis, , Greece
General Hospital of Athens - LAIKO, Athens, , Greece
University General Hospital, Athens, , Greece
Georgios Gennimatos General Hospital, Athens, , Greece
University Hospital Of Herakli, Herakleion - Crete, , Greece
University General Hospital of Ioannina, Ioannina, , Greece
University General Hospital of Larissa, Larissa, , Greece
University General Hospital of Patras, Patras, , Greece
G. Papanikolaou General Hospital, Thessaloniki, , Greece
Irccs Crob, Rionero in Vulture, Potenza, Italy
Ospedale di Castelfranco Venet, Castelfranco Veneto, Treviso, Italy
AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi, Ancona, , Italy
U.O Ematologia con Trapianto, Bari, , Italy
Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS, Bergamo, , Italy
Policlinico S.Orsola Malpighi, AOU di Bologna, Bologna, , Italy
AO Spedali Civili di Brescia, Brescia, , Italy
Policlinico di Catania, Catania, , Italy
AOU Careggi, Firenze, , Italy
U.O .C di Oncoematologia, Mirano, , Italy
Ospedale S. Luigi Gonzaga, Orbassano, , Italy
Azienda ospedaliero-universita, Parma, , Italy
Azienda Ospedaliera di Perugia, Perugia, , Italy
Ospedale Civile Santo Spirito, Pescara, , Italy
Arcispedale S.Maria Nuova, Reggio Emilia, , Italy
U.O Ematologia Azienda Ospedaliera, Regio Calabria, , Italy
Univesita La Sapienza, Roma, , Italy
AOU Policlinico Tor Vergata, Università Roma Tor Vergata, Roma, , Italy
Presidio Ospedaliero "A. Torto, Salerno, , Italy
Azienda Ospedaliera Universitaria di Sassari, Sassari, , Italy
A.O. Citta' della Salute e del, Torino, , Italy
Policlinico "G.B. Rossi" Verona, Veneto, , Italy
Centre Hospitalier de Luxembourg, Luxembourg, , Luxembourg
Haukeland Sykehus, Bergen, , Norway
Hospital Universitario de Gran Canaria Servicio de Hematología y, Las Palmas de Gran Canaria, Canarias, Spain
H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología, Santander, Cantabria, Spain
Hospital costa del sol, Marbella, Málaga, Spain
H.U. Ribera de Alzira, Alzira, , Spain
Hospital de Cruces, Barakaldo, , Spain
Hospital del Mar,Hematologia Hemotheropia, Barcelona, , Spain
H. Clinic de Barcelona, Barcelona, , Spain
Pauc Tauli, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Instit Catalia D'Oncologia, Barcelona, , Spain
Hospital Reina Sofia, Cordoba, , Spain
Hospital Josep Trueta (ICO Girona), Girona, , Spain
Hospital Virgen de Las Nieves, Grenada, , Spain
Department of Hematology, Hospital Duran i Reynals, LLobregat, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hopsital Clinico San Carlos, Madrid, , Spain
Hospital Universitario fundacion Jiminez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octobre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
H Universitario Puera de Hierro, Madrid, , Spain
Hospital Son Espaces, Mallorca, , Spain
Hospital Universitario central de Asturias, Oviedo, , Spain
Univesity Hospital de Salamanca, Salamenca, , Spain
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, , Spain
Hospital Virgen Macarena, Sevilla, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Hopsital Nuestra Senora de Valme, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Hospiral Universitario de la Fe, Valencia, , Spain
Sahlgrenska University Hospital, Gothenburg, , Sweden
Sahlgrenska University Hospital, Göteborg, , Sweden
Länssjukhuset Kalmar, Kalmar, , Sweden
Lund University Hospital - Lasarettsgatan 23, Lund, , Sweden
Karolinska University Hopsital, Stockholm, , Sweden
Maidstone Hospital, Maidstone, Kent, United Kingdom
Aberdeen Royal Infirmary - Foresterhill Road, Aberdeen, , United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Pilgrim Hospital, Boston, , United Kingdom
Monkton, Wishaw and Hairmyres Hospitals, East Kilbride, , United Kingdom
Broomfield Hospital - Mid-Essex Hospitals NHS Trust, Essex, , United Kingdom
Basildon and Thurrock Hospitals, Essex, , United Kingdom
Northwick Park Hospital, Harrow, , United Kingdom
Lincoln county Hospital, Lincoln, , United Kingdom
Aintree Hospital - Longmoor Lane, Liverpool, , United Kingdom
University Hospital South Manc, Manchester, , United Kingdom
Royal Oldham Hospital, Oldham, , United Kingdom
Radcliffe Hospitals and University - Headley Way, Headington, Oxford, , United Kingdom
Great Western Hospital, Swindon, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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