499
Participants
Start Date
February 1, 2006
Primary Completion Date
December 1, 2008
Study Completion Date
January 1, 2009
Thalidomide
Oral thalidomide (100mg or 200mg or 400 mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 + 36 days (12 cycles of 28 +/- 3 days).
Dexamethasone
High dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).
Doctors Clinic - National Kidney & Transplant Institute, Quezon City
St. Luke's Medical Center, Quezon City
University of Sto Tomas Hospital, Manila
Doctors Clinic Makati Medical Center, Makati City
"University of Multiprofiled Hospital for Active Treatment Alexandrovska - Sofia", Sofia
Military Medical Academy/Dept Haematology and Oncology, Sofia
National Center of Haematology & Transfusiology, Sofia
Chris Hani Baragwanath Hospital, Clinical Haematology Unit, Johannesburg
Johannesburg Hospital, Department of Medical Oncology, Parktown
Medical Oncology Centre of Rosebank, Johannesburg
Department of Internal Medicine - Baguio General Hospital & Medical Center, Baguio City
Clinic of Haematology, University Multiprofiled Hospital for Active Treatment, Plovdiv
Pandy Kalman Megyei Korhaz, Megyei Onkologiai Centrum, Gyula
"Clinic of Haematology, University Multiprofiled Hospital for Active Treatment G. Stranski", Pleven
Chong Hua Hospital, Cebu City
Szent-Gyorgyi Albert University II Clinic of Internal Medicine, Szeged
Tygerberg Hospital, University of Stellenbosch, Department of Haematology, Cape Town
"Clinic of Haematology, Multiprofiled Hospital for Active Treatment Sveta Marina", Varna
University of Free State, Faculty of Health Science, Dept of Hematology & Cell Biology, Bloemfontein
KBC Zagreb - Klinika za Unutarnje Bolesti, Zagreb
"Klinicka Bolnica Dubrava Klinika za Unutarnje Bolesti", Zagreb
"Klinicka Bolnica Sestre milosrdnice Klinika za Unutarnje Bolesti", Zagreb
Klinicka Bolnica MERKUR - Klinika za Unutarnje Bolesti, Zagreb
Institute of Hematology, Clinical Centre of Serbia, Belgrade
Charite, Universitatsmedizin Berlin, Campus Robert-Rossle Klinik, Berlin
Clinic for Hematology, Clinical Centre Nis, Niš
Klinika Bolnica SPLIT - Klinika za Unutarnje Bolesti, Split
Clinic for Hematology, Clinical Centre Novi Sad, Novisad
Abt. Haematologie - Onkologie/ Allg. Krankenhaus, Hamburg
Universitat Schleswig Holstein II Med. Klinik, Kiel
Hematologie - CHU Purpan Place du Dr. Baylac, Toulouse
Instituto di Ematologia e Oncologia Medica, Bologna
Hematology, Oncology & Clinical Immunology/Heinrich-Heine-University, Düsseldorf
Innere Medizin University Hospital, Münster
Universitaetsklinik - Klinik fur innere Medizin, Cologne
Klinicki Bolnicki Centar Rijeka Interna Klinika, Rijeka
Med. Klinik I/University Bonn, Bonn
CHU de Nancy - Hopital Brabois, Nancy
CHRU de Lille - Hopital Claude Huriez, Lille
Medizinische Klinik Abteilung Innere V/Universitatsklinikum, Heidelberg
Robert-Bosch-Krankenhaus GmbH, Stuttgart, Stuttgart
Onkologicke Centrum J.G. Mendela, Novi Jicin
Department of Internal Medicine, National Cancer Institute, Bratilslava
Hematology Department University Hospital, Bratilslava
Universitaetsklinik - Abteilung Innere Medizin III, Ulm
Med. Klinik II/Klinikum of the Julius-Maximilians-University, Würzburg
Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospedaliera S. Giovanni Battista, Torino
National Medical Centre Dpt Haematology, Budapest
Department of Medical Oncology/Tata Memorial Hospital, Mumbai
Department of Medical Oncology, S.L. Raheja Hospital, Mumbai
Department of Medical Oncology, Jaslok Hospital and Research Centre, Mumbai
Department of Medical Oncology, Deenanath Mangeshkar Hospital, Pune
Nizam's Institute of Medical Sciences, Department of Medical Oncology, Hyderabaad
Orchid Nursing Home, Kolkata
Interni Hemato-Onkologicka Klinika, Brno
Hematologicka Klinika, Fakultni Nemocnice Hradec Kralove, Hradec Králové
Interni Klinika, Oddeleni Hematoonkologie, Olomouc
Interni Klinika, Oddeleni Hematoonkologie, Prague
Hematologicka Klinika, Fakultni Nemocnice Kralovske Vinohrady Srobarova, Prague
Medizinische Klinik und Poliklinik I/Carl-Gustav-Carus University, Dresden
Allgemeinse Krankenhaus St. Georg Hamatologische Abteilung, Hamburg
Medizinische Klinik und Poliklinik III/Klinikum der Universitaet Muenchen, München
Abteilung Haematologie - Univeresitaetsklinikum, Saale
Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat, Győr
Department of Medical Oncology, Amrita Institute of Medical Sciences, Kerala
Department of Medical Oncology, Dayanand Medical College DMCH, Ludhiana
Department of Medical Oncology/Regional Cancer Centre, Trivandrum
SPSK, Klinika Hematologii Akademii Medycznej, Bialystok
Klinika Hematologii Akademii Medycznej w Gdanskuul, Gdansk
Katedra i Klinika Hematologii i Transplantacji Szpiku - Slaska Akademia Medyczna, Katowice
Swietokrzyskie Centrum Onkologii SPZOZ Poradnia Hematologii, Kielce
Klinika Hematologii Uniwersytetu Medycznego, Lodz
Klinika Chorob Wewnetrznych i Hemagologii, Warsaw
Katedra i Klinika Hematologii, Onkologii I Chorob Wewnetrznych, Warsaw
Instytut Hematologii i Transfuzjologii - Klinika Hematologiczna, Warsaw
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie, Warsaw
Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej, Wroclaw
Hospital da Universidade de Coimbra - Servico de Hematologia Clinica, Coimbra
Instituto Portugues de Oncologia, Lisbon
Hospital Geral de Santo Antonio - Servico de Hematologia Clinica, Porto
Hematology Department, University Hospital PJS, Košice
Department of Haematology, UCT Medical School, Cape Town
Oncology Research Unit Heartlands Hospital, Birmingham
Clinical Haematology, Guy's Hospital, London
Haematology Department - King's College Hospital, London
Department of Haematology-Oncology, The Royal Marsden NHS Foundation Trust, Surrey
Lead Sponsor
Celgene
INDUSTRY