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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00057564 |
Purpose
Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Thalidomide and Dexamethasone Drug: Dexamethasone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter Parallel-Group, Placebo Controlled, Randomized, Double-Blind Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma |
| Enrollment: | 470 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Thalidomide & Dexamethasone
|
Drug: Thalidomide and Dexamethasone
50mg thalidomide
|
|
B: Placebo Comparator
Dexamethasone and placebo
|
Drug: Dexamethasone
40mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Clinical Research Consultants, Inc. | |
| Hoover, Alabama, United States, 35216 | |
| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| James Berenson | |
| West Hollywood, California, United States, 90069 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| Melbourne Internal Medicine Associates Oncology | |
| Melbourne, Florida, United States, 32901-3182 | |
| Oncology Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Jackson Memorial Hospital and Clinics | |
| Miami, Florida, United States, 33136 | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| University of Miami Miller School/Jackson Memorial Hospital | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912-3125 | |
| United States, Illinois | |
| Southern Illinois Hematology /Oncology | |
| Centralia, Illinois, United States, 62801 | |
| Rush Cancer Institute Section of Hematology | |
| Chicago, Illinois, United States, 60612-3824 | |
| United States, Iowa | |
| University of Iowa Hospital of Clinic | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Ocshner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0922 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| Hackensack University Hospital | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157-1023 | |
| United States, Ohio | |
| Cleveland Clinic- Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| South Carolina Oncology Group | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Tennessee | |
| The Family Centre, PLLC | |
| Collierville, Tennessee, United States, 38017 | |
| East Tennessee Oncology/Hematology Associates | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Australia, Queensland | |
| Royal Brisbane Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Haematology Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, Victoria | |
| The Alfred Hospital | |
| Melbourne, Victoria, Australia, 3004 | |
| Peter MacCallum Cancer Institute | |
| Melbourne, Victoria, Australia, 3002 | |
| Frankston Hospital | |
| Frankston, Victoria, Australia, 3199 | |
| Bone Marrow Transplant Service Dep't of Clinical Haematology and Medical Oncology | |
| Parkville, Victoria, Australia, 3050 | |
| Belgium | |
| Institut Jules Bordet Dep't of Clinical Haematology | |
| Brussels, Belgium, 1000 | |
| Dep't. Of Haematology Academisch Ziekenhuis VUB | |
| Brussels, Belgium, 1090 | |
| University Hospital Ghent Dep't of Haematology | |
| Ghent, Belgium, 900 | |
| Bulgaria | |
| Military Medical Academy | |
| Sofia, Bulgaria | |
| UMHAT Alexandrovska | |
| Alexandrovska, Bulgaria | |
| National Center of Haematology and Transfusiology | |
| Sofia, Bulgaria, 1756 | |
| Canada, Nova Scotia | |
| Dalhousie University | |
| Halifax, Nova Scotia, Canada, B3H2Y9 | |
| Canada, Ontario | |
| University Health Network Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont | |
| Fleurimont, Quebec, Canada, J1H 5N4 | |
| McGill University | |
| Montreal, Quebec, Canada, PQ H2W 1S6 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre University of Saskatoon | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Germany | |
| Universitaetsklinikum Dusseldorf Klinik fuer Haematologie | |
| Dusseldorf, Germany | |
| Hungary | |
| St. Laszlo Hoszpital | |
| Budapest, Hungary | |
| Petz Aladar County Hospital | |
| Gyor, Hungary, 9002 | |
| Ireland | |
| Hope Directorate Dep't. Haematology St. James's Hospital | |
| Dublin, Ireland, 8 | |
| Ireland, Limerick | |
| MidWestern Regional Hospital Haematology Dpt. | |
| Dooradoyle, Limerick, Ireland | |
| Israel | |
| Rambam Medical Center Dep't. Of Hematology | |
| Haifa, Israel, 31096 | |
| Tel Aviv Sourasky Medical Center Hematology Institute | |
| Tel Aviv, Israel, 64239 | |
| Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Israel, Jerusalem | |
| Hadassah University Hospital Hematology Dep't | |
| Ein Kerem, Jerusalem, Israel, 91120 | |
| Italy | |
| Azienda Ospedaliera San Martino | |
| Genova, Italy, 16132 | |
| Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli" | |
| Bologna, Italy, 40138 | |
| Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico | |
| Bari, Italy, 11- | |
| Ospedale Niguarda Ca Granda | |
| Milano, Italy, 20162 | |
| Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia | |
| Roma, Italy, 00161 | |
| Clinica Ematologica Policlinico Universitario | |
| Udine, Italy, 33100 | |
| Poland | |
| Medical Academy of Bialystok | |
| Bialystok, Poland, 15-276 | |
| Institute of Internal Diseases University of Medicine | |
| Gdansk, Poland, 80-211 | |
| Jagiellonian University Collegium Medicum Department of Hematology | |
| Krakow, Poland, 31-501 | |
| Medical University of Lodz | |
| Lodz, Poland, 93-509 | |
| Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors' | |
| Lublin, Poland, 20-022 | |
| Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases | |
| Warsaw, Poland, 02-097 | |
| Russian Federation | |
| Chelyabinsk Regional Clinical Hospital Hematology Dpt | |
| Chelyabinsk, Russian Federation, 454076 | |
| Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre | |
| Ekaterinburg, Russian Federation, 620102 | |
| Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation | |
| Samara, Russian Federation, 443095 | |
| Burdenko Central Military Clinical Hospital Hematology Center | |
| Moscow, Russian Federation, 105229 | |
| Russian Academy of Medical Sciences Scientific Center of Hematology | |
| Moscow, Russian Federation, 125167 | |
| Nizhny Novgorod Clinical Hospital | |
| Novgorod, Russian Federation, 603126 | |
| Novosibirsk State Regional Clinical Hospital Hematology Centre | |
| Novosibirsk, Russian Federation, 630087 | |
| Republican Clinical Hospital #1 Hematology Dpt. | |
| Izhevsk, Russian Federation, 426039 | |
| Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy | |
| Shosse, Russian Federation, 115478 | |
| Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit | |
| St. Petersburg, Russian Federation, 193024 | |
| St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic | |
| St. Petersburg, Russian Federation, 197022 | |
| Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders | |
| St. Petersburg, Russian Federation, 197110 | |
| Spain | |
| Hospital Doce de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Universitario de la Princessa | |
| Madrid, Spain, 28006 | |
| Hospital Clinic | |
| Barcelona, Spain, 08036 | |
| Clinica Universitaria de Navarra | |
| Pamplona, Spain, 31080 | |
| Hospital Universitario de Salamanca | |
| Salamanca, Spain, 37007 | |
| Hospital Universitario Marques de Valdecilla | |
| Santander, Spain, 39008 | |
| Switzerland | |
| Universitatsspital Zurich | |
| Zurich, Switzerland, 8091 | |
| Ukraine | |
| Cherkassy Regional Oncology Center | |
| Cherkassy, Ukraine, 18009 | |
| Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre | |
| Dnepropetrovsk, Ukraine, 49044 | |
| Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department | |
| Ivano-Frankovsk, Ukraine, 76000 | |
| Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology | |
| Kharkov, Ukraine, 61070 | |
| Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department | |
| Kiev, Ukraine, 03115 | |
| Kiev Institute of Oncology of the UAMS Systemic Malignancies Department | |
| Kiev, Ukraine, 03022 | |
| Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group | |
| Kiev, Ukraine, 04060 | |
| Institute of Blood Pathology and Transfusion Medicine of the UAMS | |
| Lvov, Ukraine, 79044 | |
| Odessa Regional Clinical Hospital Hematology Dep't | |
| Odessa, Ukraine, 65025 | |
| Zaporozhje Regional Clinical Hospital Hematology Dpt | |
| Zaporozhye, Ukraine, 69600 | |
| Zhitomir Regional Clinical Hospital Hematology Centre | |
| Zhitomir, Ukraine, 10002 | |
| United Kingdom | |
| Belfast City Hospital Haematology Dpt. | |
| Belfast, United Kingdom, BT9 7AB | |
| Guys Hospital | |
| London, United Kingdom, SE19RT | |
| Guys Hospital | |
| London, United Kingdom, SE1 9RT | |
| Study Director: | Robert Knight, MD | Celgene Corporation |
More Information
| Responsible Party: | Celgene Corporation ( Robert Knight MD, VP Oncology/Hematology ) |
| Study ID Numbers: | THAL-MM-003 |
| Study First Received: | April 4, 2003 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00057564 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Newly Diagnosed Multiple Myeloma Multiple Myeloma |
|
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Immunologic Factors Thalidomide Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders |
Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Growth Substances Gastrointestinal Agents Vascular Diseases Angiogenesis Inhibitors Immunosuppressive Agents |
