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Brief Title: A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma
Official Title: A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma
Study ID: NCT00057564
Brief Summary: To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clinical Research Consultants, Inc., Hoover, Alabama, United States
Arizona Clinical Research Center, Tucson, Arizona, United States
UCLA School of Medicine, Los Angeles, California, United States
James Berenson, West Hollywood, California, United States
Mayo Clinic, Jacksonville, Florida, United States
Melbourne Internal Medicine Associates Oncology, Melbourne, Florida, United States
Jackson Memorial Hospital and Clinics, Miami, Florida, United States
University of Miami Miller School/Jackson Memorial Hospital, Miami, Florida, United States
University of Miami, Miami, Florida, United States
Oncology Hematology Group of South Florida, Miami, Florida, United States
Medical College of Georgia, Augusta, Georgia, United States
Southern Illinois Hematology /Oncology, Centralia, Illinois, United States
Rush Cancer Institute Section of Hematology, Chicago, Illinois, United States
University of Iowa Hospital of Clinic, Iowa City, Iowa, United States
Ocshner Clinic Foundation, New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Hackensack University Hospital, Hackensack, New Jersey, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
Cleveland Clinic- Taussig Cancer Center, Cleveland, Ohio, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
South Carolina Oncology Group, West Columbia, South Carolina, United States
The Family Centre, PLLC, Collierville, Tennessee, United States
East Tennessee Oncology/Hematology Associates, Knoxville, Tennessee, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Royal Brisbane Hospital, Herston, Queensland, Australia
Haematology Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Frankston Hospital, Frankston, Victoria, Australia
Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology, Parkville, Victoria, Australia
Institut Jules Bordet Dep't of Clinical Haematology, Brussels, , Belgium
Dept. Of Haematology Academisch Ziekenhuis VUB, Brussels, , Belgium
University Hospital Ghent Dep't of Haematology, Ghent, , Belgium
UMHAT Alexandrovska, Alexandrovska, , Bulgaria
National Center of Haematology and Transfusiology, Sofia, , Bulgaria
Military Medical Academy, Sofia, , Bulgaria
Dalhousie University, Halifax, Nova Scotia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
University Health Network Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont, Fleurimont, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Saskatoon Cancer Centre University of Saskatoon, Saskatoon, Saskatchewan, Canada
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie, Dusseldorf, , Germany
St. Laszlo Hoszpital, Budapest, , Hungary
Petz Aladar County Hospital, Gyor, , Hungary
MidWestern Regional Hospital Haematology Dpt., Dooradoyle, Limerick, Ireland
Hope Directorate Dep't. Haematology St. James's Hospital, Dublin, , Ireland
Hadassah University Hospital Hematology Dep't, Ein Kerem, Jerusalem, Israel
Rambam Medical Center Dep't. Of Hematology, Haifa, , Israel
Tel Aviv Sourasky Medical Center Hematology Institute, Tel Aviv, , Israel
Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center, Tel Hashomer, , Israel
Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico, Bari, , Italy
Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli", Bologna, , Italy
Azienda Ospedaliera San Martino, Genova, , Italy
Ospedale Niguarda Ca Granda, Milano, , Italy
Policlinico San Matteo, Pavia, , Italy
Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia, Roma, , Italy
Clinica Ematologica Policlinico Universitario, Udine, , Italy
Medical Academy of Bialystok, Bialystok, , Poland
Institute of Internal Diseases University of Medicine, Gdansk, , Poland
Jagiellonian University Collegium Medicum Department of Hematology, Krakow, , Poland
Medical University of Lodz, Lodz, , Poland
Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors', Lublin, , Poland
Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases, Warsaw, , Poland
Chelyabinsk Regional Clinical Hospital Hematology Dpt, Chelyabinsk, , Russian Federation
Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre, Ekaterinburg, , Russian Federation
Republican Clinical Hospital #1 Hematology Dpt., Izhevsk, , Russian Federation
Burdenko Central Military Clinical Hospital Hematology Center, Moscow, , Russian Federation
Russian Academy of Medical Sciences Scientific Center of Hematology, Moscow, , Russian Federation
Nizhny Novgorod Clinical Hospital, Novgorod, , Russian Federation
Novosibirsk State Regional Clinical Hospital Hematology Centre, Novosibirsk, , Russian Federation
Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation, Samara, , Russian Federation
Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy, Shosse, , Russian Federation
Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit, St. Petersburg, , Russian Federation
St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic, St. Petersburg, , Russian Federation
Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders, St. Petersburg, , Russian Federation
Hospital Clinic, Barcelona, , Spain
Hospital Universitario de la Princessa, Madrid, , Spain
Hospital Doce de Octubre, Madrid, , Spain
Clinica Universitaria de Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Universitatsspital Zurich, Zurich, , Switzerland
Cherkassy Regional Oncology Center, Cherkassy, , Ukraine
Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre, Dnepropetrovsk, , Ukraine
Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department, Ivano-Frankovsk, , Ukraine
Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology, Kharkov, , Ukraine
Kiev Institute of Oncology of the UAMS Systemic Malignancies Department, Kiev, , Ukraine
Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department, Kiev, , Ukraine
Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group, Kiev, , Ukraine
Institute of Blood Pathology and Transfusion Medicine of the UAMS, Lvov, , Ukraine
Odessa Regional Clinical Hospital Hematology Dep't, Odessa, , Ukraine
Zaporozhje Regional Clinical Hospital Hematology Dpt, Zaporozhye, , Ukraine
Zhitomir Regional Clinical Hospital Hematology Centre, Zhitomir, , Ukraine
Belfast City Hospital Haematology Dpt., Belfast, , United Kingdom
Guys Hospital, London, , United Kingdom
Guys Hospital, London, , United Kingdom
Name: Robert Knight, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR