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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Thalidomide & Dexamethasone) | Experimental | Thalidomide 50mg/day + Dexamethasone 40mg |
|
| B (Dexamethasone and placebo) | Placebo Comparator | Dexamethasone and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A (Thalidomide + Dexamethasone) | Drug | Thalidomide 50mg/day + Dexamethasone 40mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to tumor progression (TTP) | Time to tumor progression (TTP) | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who survived | Number of patients who survived | Up to 3 years |
| Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) | Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knight, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Consultants, Inc. | Hoover | Alabama | 35216 | United States | ||
| Arizona Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18362366 | Result | Rajkumar SV, Rosinol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Blade J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. doi: 10.1200/JCO.2007.14.1853. Epub 2008 Mar 24. |
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| B (Placebo + Dexamethasone) | Drug | Placebo + Dexamethasone 40mg |
|
|
| Up to 3 years |
| Myeloma response rate | Myeloma response determination criteria developed by Bladé et al 1998 | Up to 3 years |
| Number of participants with adverse events | Number of participants with adverse events | Up to 3 years |
| Tucson |
| Arizona |
| 85712 |
| United States |
| UCLA School of Medicine | Los Angeles | California | 90095 | United States |
| James Berenson | West Hollywood | California | 90069 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Melbourne Internal Medicine Associates Oncology | Melbourne | Florida | 32901-3182 | United States |
| Jackson Memorial Hospital and Clinics | Miami | Florida | 33136 | United States |
| University of Miami Miller School/Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Oncology Hematology Group of South Florida | Miami | Florida | 33176 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912-3125 | United States |
| Southern Illinois Hematology /Oncology | Centralia | Illinois | 62801 | United States |
| Rush Cancer Institute Section of Hematology | Chicago | Illinois | 60612-3824 | United States |
| University of Iowa Hospital of Clinic | Iowa City | Iowa | 52242 | United States |
| Ocshner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0922 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Hackensack University Hospital | Hackensack | New Jersey | 07601 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1023 | United States |
| Cleveland Clinic- Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| South Carolina Oncology Group | West Columbia | South Carolina | 29169 | United States |
| The Family Centre, PLLC | Collierville | Tennessee | 38017 | United States |
| East Tennessee Oncology/Hematology Associates | Knoxville | Tennessee | 37920 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Royal Brisbane Hospital | Herston | Queensland | 4029 | Australia |
| Haematology Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Frankston Hospital | Frankston | Victoria | 3199 | Australia |
| Peter MacCallum Cancer Institute | Melbourne | Victoria | 3002 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology | Parkville | Victoria | 3050 | Australia |
| Institut Jules Bordet Dep't of Clinical Haematology | Brussels | 1000 | Belgium |
| Dept. Of Haematology Academisch Ziekenhuis VUB | Brussels | 1090 | Belgium |
| University Hospital Ghent Dep't of Haematology | Ghent | 900 | Belgium |
| UMHAT Alexandrovska | Alexandrovska | Bulgaria |
| National Center of Haematology and Transfusiology | Sofia | 1756 | Bulgaria |
| Military Medical Academy | Sofia | Bulgaria |
| Dalhousie University | Halifax | Nova Scotia | B3H2Y9 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| University Health Network Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont | Fleurimont | Quebec | J1H 5N4 | Canada |
| McGill University | Montreal | Quebec | PQ H2W 1S6 | Canada |
| Saskatoon Cancer Centre University of Saskatoon | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Universitaetsklinikum Dusseldorf Klinik fuer Haematologie | Düsseldorf | Germany |
| St. Laszlo Hoszpital | Budapest | Hungary |
| Petz Aladar County Hospital | Győr | 9002 | Hungary |
| MidWestern Regional Hospital Haematology Dpt. | Dooradoyle | Limerick | Ireland |
| Hope Directorate Dep't. Haematology St. James's Hospital | Dublin | 8 | Ireland |
| Hadassah University Hospital Hematology Dep't | ‘En Kerem | Jerusalem | 91120 | Israel |
| Rambam Medical Center Dep't. Of Hematology | Haifa | 31096 | Israel |
| Tel Aviv Sourasky Medical Center Hematology Institute | Tel Aviv | 64239 | Israel |
| Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico | Bari | 11 | Italy |
| Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli" | Bologna | 40138 | Italy |
| Azienda Ospedaliera San Martino | Genova | 16132 | Italy |
| Ospedale Niguarda Ca Granda | Milan | 20162 | Italy |
| Policlinico San Matteo | Pavia | 27100 | Italy |
| Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia | Roma | 00161 | Italy |
| Clinica Ematologica Policlinico Universitario | Udine | 33100 | Italy |
| Medical Academy of Bialystok | Bialystok | 15-276 | Poland |
| Institute of Internal Diseases University of Medicine | Gdansk | 80-211 | Poland |
| Jagiellonian University Collegium Medicum Department of Hematology | Krakow | 31-501 | Poland |
| Medical University of Lodz | Lodz | 93-509 | Poland |
| Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors' | Lublin | 20-022 | Poland |
| Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases | Warsaw | 02-097 | Poland |
| Chelyabinsk Regional Clinical Hospital Hematology Dpt | Chelyabinsk | 454076 | Russia |
| Republican Clinical Hospital #1 Hematology Dpt. | Izhevsk | 426039 | Russia |
| Burdenko Central Military Clinical Hospital Hematology Center | Moscow | 105229 | Russia |
| Russian Academy of Medical Sciences Scientific Center of Hematology | Moscow | 125167 | Russia |
| Novosibirsk State Regional Clinical Hospital Hematology Centre | Novosibirsk | 630087 | Russia |
| Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit | Saint Petersburg | 193024 | Russia |
| St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic | Saint Petersburg | 197022 | Russia |
| Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders | Saint Petersburg | 197110 | Russia |
| Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation | Samara | 443095 | Russia |
| Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy | Shosse | 115478 | Russia |
| Nizhny Novgorod Clinical Hospital | Veliky Novgorod | 603126 | Russia |
| Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre | Yekaterinburg | 620102 | Russia |
| Hospital Clinic | Barcelona | 08036 | Spain |
| Hospital Universitario de la Princessa | Madrid | 28006 | Spain |
| Hospital Doce de Octubre | Madrid | 28041 | Spain |
| Clinica Universitaria de Navarra | Pamplona | 31080 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Universitatsspital Zurich | Zurich | 8091 | Switzerland |
| Cherkassy Regional Oncology Center | Cherkassy | 18009 | Ukraine |
| Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre | Dnipro | 49044 | Ukraine |
| Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department | Ivano-Frankivsk | 76000 | Ukraine |
| Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology | Kharkiv | 61070 | Ukraine |
| Kiev Institute of Oncology of the UAMS Systemic Malignancies Department | Kiev | 03022 | Ukraine |
| Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department | Kiev | 03115 | Ukraine |
| Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group | Kiev | 04060 | Ukraine |
| Institute of Blood Pathology and Transfusion Medicine of the UAMS | Lviv | 79044 | Ukraine |
| Odessa Regional Clinical Hospital Hematology Dep't | Odesa | 65025 | Ukraine |
| Zaporozhje Regional Clinical Hospital Hematology Dpt | Zaporizhzhya | 69600 | Ukraine |
| Zhitomir Regional Clinical Hospital Hematology Centre | Zhytomyr | 10002 | Ukraine |
| Belfast City Hospital Haematology Dpt. | Belfast | BT9 7AB | United Kingdom |
| Guys Hospital | London | SE1 9RT | United Kingdom |
| Guys Hospital | London | SE19RT | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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