Spots Global Cancer Trial Database for A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q
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Trial Identification
Brief Title: A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare The Efficacy And Safety of Lenalidomide (Revlimid®) Versus Placebo In Subjects With Transufsion-Dependent Anemia Due to IPSS Low Or Imtermidate-1 Risk Myelodysplastic Syndromes Without Deletion 5Q(31) And Unresponsive Or Refractory To Erthropoiesis-Stimulating Agents
Study ID: NCT01029262
Conditions
Study Description
Brief Summary: The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California at Los Angeles, Los Angeles, California, United States
Southern Illinois Hematology Oncology, Centralia, Illinois, United States
Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Wollongong Hospital, Wollongong, New South Wales, Australia
Royal Adelaide Hospital Institute of Medical and Veterinary Science, Adelaide, South Australia, Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
Medizinische Universitat Innsbruck, Innsbruck, , Austria
Krankenhaus der Elisabethinen Linz, I Interne Abteilung, Linz, , Austria
Universitatsklinik fur Innere Medizin Salzburg, Salzburg, , Austria
Klinikum Wels-Grieskirchen GmbH, Weis, , Austria
Wiener Gebietskrankenkasse-Hanusch-Krankenhaus, Wien, , Austria
AZ St-Jan Brugge Oostende AV, Brugge, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Centre Hospitalier Universitaire de Liege, Liege, , Belgium
Center Hospitalier Universitaire Ambroise Pare, Mons, , Belgium
Cliniques Universitaires UCL de Mont-Godine, Namur, , Belgium
Tom Baker Cancer Center, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Cancer Care Manitoba, Winnepeg, Manitoba, Canada
Sunnybrook Regional Cancer Center, Toronto, Ontario, Canada
Princess Margaret Hospital and University of Toronto, Toronto, Ontario, Canada
Maisonneuve Rosemont, Montreal, Quebec, Canada
McGill University, Dept. Oncology Clinical Research Program, Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Vseobecna Fakultni Nemocnice v Praze, Prague, , Czechia
Ustav hematologie a krevni transfuze, Praha, , Czechia
CHU d'Angers, Angers, , France
Hopital Avicenne, Bobigny Cedex, , France
Hopital A. Michallon, La Tronche, , France
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang, Lille, , France
Institut Paoli-Calmettes, Marseille cedex, , France
Groupe hospitalier Cochin Saint-Vincent de Paul, Paris Cedex, , France
BAG Freiberg-Richter, Jacobash, Illmer, Wolf, Dresden, , Germany
Marien Hospital, Duesseldorf, , Germany
Sankt Johannes Hospital Duisburg, Duisberg, , Germany
Universitätsklinikum Düsseldorf, Düesseldorf, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Klinikum Mannheim der Universitat Heidelberg, Heidelberg, , Germany
Universitat zu Koln, Köln, , Germany
Universitatsklinikum Mannheim, Mannheim, , Germany
TU München - Klinikum rechts der Isar, München, , Germany
Rabin Medical Center, Petach-Tikva, , Israel
The Chaim Sheba Medical Center, Tel Hashomer, , Israel
Tel-Aviv Sourasky Medical Center, Tel-Aviv, , Israel
Az. Osp. SS.Antonio e Biagio - SC Ematologia, Alessandria, , Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna, , Italy
P.O. Ospedale Roberto Binaghi (UNI CA/ASL 8), Cagliari, , Italy
Azienda Ospedaliero-Universitaria di Cagliari, Cagliari, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliera Cardarelli, Naples, , Italy
AOU San Luigi Gonzaga, Orbassano, , Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture, Rionero in Vulture, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma, , Italy
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma, Roma, , Italy
Policlinico Agostino Gemelli - Istituto di Ematologia, Roma, , Italy
Policlinico Univeristario di Udine, Udine, , Italy
Hiroshima University Hospital, Hiroshima, , Japan
Tokai University School of Medicine, Isehara City, Kanagawa, , Japan
Kameda General Hospital, Kamogawa, , Japan
Kanazawa University Hospital, Kanazawa, , Japan
Nagasaki Unversity Hospital, Nagasaki, , Japan
National Hospital Organization Nagoya Medical Center, Nagoya, , Japan
Osaka Red Cross Hospital, Osaka, , Japan
Tohoku University Hospital, Sendai, , Japan
Japanese Red Cross Medical Center, Shibuya, , Japan
Jichi Medical University Hospital, Shimotsuke, , Japan
Kanto Medical Center NTT EC, Shinagawa, , Japan
Katedra i Klinika Hematologii i Transplantacji Szpiku - SLASKIEGO UNIWERSYTETU MEDYCZNEGO, Gdansk, , Poland
Uniwersytet Medyczny w Lodzi, Lodz, , Poland
Instytut Hematologii i Transfuzjologii, Klinika Hematologii, Warsaw, , Poland
Hospitais da Universidade de Coimbra, Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa, Lisboa, , Portugal
Hospital Geral de Santo Antonio, Porto, , Portugal
Hospital Clinic Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Son Llatzer, Palma de Mallorca, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Gazi Universitesi Tip Fakltesi, Ankara, , Turkey
Akdeniz Universitesi Tip Fakultesi, Antalya, , Turkey
Istanbul Universitesi Istanbul, Istanbul, , Turkey
Dokuz Eylul Universitesi Tip Faiultesi, Izimir, , Turkey
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Saint James University Hospital, Leeds, , United Kingdom
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, , United Kingdom
King's College Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
John Radcliffe Hospital, Oxford, , United Kingdom
Contact Details
Name: Albert Hoenekopp, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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