239
Participants
Start Date
January 26, 2010
Primary Completion Date
March 17, 2013
Study Completion Date
May 9, 2018
Lenalidomide
One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
Placebo
3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
Wiener Gebietskrankenkasse-Hanusch-Krankenhaus, Vienna
Cliniques Universitaires Saint-Luc, Brussels
BAG Freiberg-Richter, Jacobash, Illmer, Wolf, Dresden
Wollongong Hospital, Wollongong
Universitair Ziekenhuis Antwerpen, Edegem
Centre Hospitalier Universitaire de Liege, Liège
Krankenhaus der Elisabethinen Linz, I Interne Abteilung, Linz
Princess Alexandra Hospital, Woolloongabba
Klinikum Wels-Grieskirchen GmbH, Weis
Universitatsklinik fur Innere Medizin Salzburg, Salzburg
Cliniques Universitaires UCL de Mont-Godine, Namur
Grand Hopital de Charleroi, Charleroi
Medizinische Universitat Innsbruck, Innsbruck
Center Hospitalier Universitaire Ambroise Pare, Mons
Hospital Son Llatzer, Palma de Mallorca
AZ St-Jan Brugge Oostende AV, Bruges
Columbia University Medical Center, New York
AOU San Luigi Gonzaga, Orbassano
Vseobecna Fakultni Nemocnice v Praze, Prague
Institut Paoli-Calmettes, Marseille
Az. Osp. SS.Antonio e Biagio - SC Ematologia, Alessandria
Hospital Universitario La Paz, Madrid
Hospital Universitario Virgen de la Victoria, Málaga
Medizinische Hochschule Hannover, Hanover
Policlinico Univeristario di Udine, Udine
Istanbul Universitesi Istanbul, Istanbul
Dokuz Eylul Universitesi Tip Faiultesi, Izimir
Hospital Universitario de Salamanca, Salamanca
Hopital A. Michallon, La Tronche
A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna
Universitätsklinikum Düsseldorf, Düesseldorf
Marien Hospital, Düsseldorf
Hospital Universitario Virgen Del Rocio, Seville
Hospital Universitario La Fe, Valencia
Sankt Johannes Hospital Duisburg, Duisberg
CHU d'Angers, Angers
Rabin Medical Center, Petah Tikva
Azienda Ospedaliero-Universitaria Careggi, Florence
Universitat zu Koln, Cologne
The Chaim Sheba Medical Center, Tel Litwinsky
Medical College of Wisconsin, Milwaukee
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang, Lille
Southern Illinois Hematology Oncology, Centralia
Tel-Aviv Sourasky Medical Center, Tel Aviv
Universitatsklinikum Mannheim, Mannheim
Klinikum Mannheim der Universitat Heidelberg, Heidelberg
Groupe hospitalier Cochin Saint-Vincent de Paul, Paris
University of Texas MD Anderson Cancer Center, Houston
Fakultni nemocnice Olomouc, Olomouc
Azienda Ospedaliera Cardarelli, Naples
TU München - Klinikum rechts der Isar, München
University of California at Los Angeles, Los Angeles
Hopital Avicenne, Bobigny
Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center, Lebanon
Hackensack University Medical Center, Hackensack
Royal Adelaide Hospital Institute of Medical and Veterinary Science, Adelaide
Tom Baker Cancer Center, Calgary
University of Alberta Hospital, Edmonton
Cancer Care Manitoba, Winnepeg
Sunnybrook Regional Cancer Center, Toronto
Princess Margaret Hospital and University of Toronto, Toronto
Maisonneuve Rosemont, Montreal
McGill University, Dept. Oncology Clinical Research Program, Montreal
Hopital du Sacre-Coeur de Montreal, Montreal
Fakultni nemocnice Brno, Brno
Ustav hematologie a krevni transfuze, Prague
P.O. Ospedale Roberto Binaghi (UNI CA/ASL 8), Cagliari
Azienda Ospedaliero-Universitaria di Cagliari, Cagliari
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture, Rionero in Vulture
Hiroshima University Hospital, Hiroshima
Kanazawa University Hospital, Kanazawa
Nagasaki Unversity Hospital, Nagasaki
Osaka Red Cross Hospital, Osaka
Jichi Medical University Hospital, Shimotsuke
Kanto Medical Center NTT EC, Shinagawa City
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma
Azienda Policlinico Umberto I, Universita La Sapienzadi Roma, Roma
Policlinico Agostino Gemelli - Istituto di Ematologia, Roma
Tokai University School of Medicine, Isehara City, Kanagawa
Kameda General Hospital, Kamogawa
National Hospital Organization Nagoya Medical Center, Nagoya
Tohoku University Hospital, Sendai
Japanese Red Cross Medical Center, Shibuya City
Katedra i Klinika Hematologii i Transplantacji Szpiku - SLASKIEGO UNIWERSYTETU MEDYCZNEGO, Gdansk
Uniwersytet Medyczny w Lodzi, Lodz
Instytut Hematologii i Transfuzjologii, Klinika Hematologii, Warsaw
Hospitais da Universidade de Coimbra, Coimbra
Instituto Portugues de Oncologia de Lisboa, Lisbon
Hospital Geral de Santo Antonio, Porto
Hospital Clinic Provincial de Barcelona, Barcelona
Gazi Universitesi Tip Fakltesi, Ankara
Akdeniz Universitesi Tip Fakultesi, Antalya
Royal Bournemouth Hospital, Bournemouth
University Hospital of Wales, Cardiff
Saint James University Hospital, Leeds
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London
King's College Hospital, London
Christie Hospital, Manchester
John Radcliffe Hospital, Oxford
Lead Sponsor
Celgene
INDUSTRY