Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone (UPFRONT)
28 mars 2014 mis à jour par: Millennium Pharmaceuticals, Inc.
Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE, Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone
This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
502
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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San Juan, Porto Rico, 00919-1227
- Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center
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Alabama
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Birmingham, Alabama, États-Unis, 35205
- Birmingham Hematology Oncology Assciates, LLC
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Arizona
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Casa Grande, Arizona, États-Unis, 85222
- Desert Oasis Cancer Center
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Sedona, Arizona, États-Unis, 86336
- Northern Arizona Hematology & Oncology Associates - AOA
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Tucson, Arizona, États-Unis, 85704
- Arizona Oncology Associates
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Arkansas
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Hot Springs, Arkansas, États-Unis, 71913
- Heritage Physician Group Oncology
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Little Rock, Arkansas, États-Unis, 72205
- Hematology Oncology Services of Arkansas
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California
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Anaheim, California, États-Unis, 92801
- Pacific Cancer Medical Centre
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Beverly Hills, California, États-Unis, 90211-1850
- Tower Cancer Research Foundation
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Corona, California, États-Unis, 92882
- Compassionate Cancer Care Medical Group
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Fountain Valley, California, États-Unis, 92708
- Robert A. Moss, MD, FACP, Inc.
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Fountain Valley, California, États-Unis, 92708
- Compassionate Cancer Care Medical Group, Inc.
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Fresno, California, États-Unis, 93720
- Cancer Care Associates
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Glendale, California, États-Unis, 91204
- Glendale Memorial Hospital & Health Center
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Greenbrae, California, États-Unis, 94904
- California Cancer Care
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Highland, California, États-Unis, 92346
- Beaver Medical Group
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Laguna Beach, California, États-Unis, 92882
- Edward A. Wagner, MD
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Montebello, California, États-Unis, 90640
- Clinical Trials and Research Associates, Inc.
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Orange, California, États-Unis, 92868
- Medical Oncology Care Associates
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Oxnard, California, États-Unis, 93030
- Ventura County Hematology Oncology Specialists
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Poway, California, États-Unis, 92064
- Southwest Cancer Care
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Rancho Mirage, California, États-Unis, 92270
- Desert Cancer Care, Incorporated
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Riverside, California, États-Unis, 92501
- Compassionate Cancer Care Medical Group, Inc.
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Sacramento, California, États-Unis, 95816
- Sutter Cancer center
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Soquel, California, États-Unis, 95073
- Cancer Research & Prevention Center
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Stockton, California, États-Unis, 95204
- Stockton Hematology/Oncology
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Westlake Village, California, États-Unis, 91361
- Trivalley Oncology Hematology
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Colorado
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Denver, Colorado, États-Unis, 80218
- Rocky Mountain Cancer Center
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Connecticut
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Southington, Connecticut, États-Unis, 06489
- Cancer Center of Central Connecticut
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Delaware
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Newark, Delaware, États-Unis, 19718
- Christiana Care Health Services
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Florida
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Boca Raton, Florida, États-Unis, 33486
- The Center for Hematology-Oncology
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Brooksville, Florida, États-Unis, 34613
- Pasco Hernando Oncology
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Coral Springs, Florida, États-Unis, 33065
- Northwest Oncology & Hematology Associates
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Fort Myers, Florida, États-Unis, 33901
- Florida Cancer Specialists
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Hollywood, Florida, États-Unis, 33021
- Horizon Institute for Clinical Research
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Jacksonville, Florida, États-Unis, 32207
- Baptist Cancer Institute
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Jacksonville, Florida, États-Unis, 32209
- University of Florida- Jacksonville
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Lake City, Florida, États-Unis, 32024
- Cancer Care of North Florida
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Lakeland, Florida, États-Unis, 33805
- Lakeland Regional Cancer Center
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Lecanto, Florida, États-Unis, 34461
- Cancer & Blood Disease Center
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New Port Richey, Florida, États-Unis, 34655
- Florida Cancer Institute
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New Port Richey, Florida, États-Unis, 34652
- Pasco Hernando Oncology
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North Miami Beach, Florida, États-Unis, 33179
- Innovative Medical Research of South Florida Inc.
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Ocala, Florida, États-Unis, 34474
- Ocala Oncology Center
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Ocoee, Florida, États-Unis, 34761
- Cancer Centers of Florida, P.A.
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Orlando, Florida, États-Unis, 32806
- MD Anderson Cancer Center Orlando
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Port St. Lucie, Florida, États-Unis, 34952
- Hematology Oncology Associates of the Treasure Coast, PA
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St. Petersburg, Florida, États-Unis, 33705
- Gulfcoast Oncology Associates
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West Palm Beach, Florida, États-Unis, 33458
- S. Florida Oncology/ Hematology
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Georgia
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Augusta, Georgia, États-Unis, 30901
- Medical Oncology Associates of Augusta
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Macon, Georgia, États-Unis, 31201
- Central Georgia Cancer Care
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Marietta, Georgia, États-Unis, 30060
- Northwest Georgia Oncology Centers, P.C.
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Savannah, Georgia, États-Unis, 31405
- Summit Cancer Care
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Idaho
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Boise, Idaho, États-Unis, 83712
- St. Lukes Mountain States Tumor Institute
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Idaho Falls, Idaho, États-Unis, 83404
- Snake River Oncology of Eastern Idaho, PLLC.
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Illinois
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Arlington Heights, Illinois, États-Unis, 60005
- Cancer Care & Hematology Specialists of Chicagoland
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Chicago, Illinois, États-Unis, 60637
- University of Chicago
-
Chicago, Illinois, États-Unis, 60612
- John H. Stroger, Jr. Hospital of Cook County
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Chicago, Illinois, États-Unis, 60611
- Hematology Oncology Associates of Illinois
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Chicago, Illinois, États-Unis, 60657
- Hematology Oncology Associates of Illinois
-
Elmhurst, Illinois, États-Unis, 60126
- Elmhurst Memorial Hospital
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Gurnee, Illinois, États-Unis, 60031-3399
- Oncology Hematology Associates of North Illinois Ltd.
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Joliet, Illinois, États-Unis, 60435
- Joliet Oncology-Hematology Associates, Ltd.
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Joliet, Illinois, États-Unis, 60432
- Midwest Center for Hematology / Oncology
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Naperville, Illinois, États-Unis, 60540
- Hematology Oncology Consultants, Inc.
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Niles, Illinois, États-Unis, 60714
- Cancer Care and Hematology Specialists of Chicagoland
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Normal, Illinois, États-Unis, 61761
- Mid-Illinois Hem & Onc
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Quincy, Illinois, États-Unis, 62301
- Quincy Medical Group
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Indiana
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Evansville, Indiana, États-Unis, 47713
- Deaconess Clinic Incorporated
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Indianapolis, Indiana, États-Unis, 46227
- Central Indiana Cancer Centers
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Indianapolis, Indiana, États-Unis, 46254
- Investigative Clinical Research of Indiana, LLC
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Lafayette, Indiana, États-Unis, 47904
- Clarian Arnett Cancer Center
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Muncie, Indiana, États-Unis, 47303
- Medical Consultants, Pc
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New Albany, Indiana, États-Unis, 47150
- Cancer Care Center
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South Bend, Indiana, États-Unis, 46601
- Memorial Hospital of South Bend
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Terre Haute, Indiana, États-Unis, 47802
- Hope Center
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Iowa
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Ames, Iowa, États-Unis, 50010
- McFarland Clinic, P.C.
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Council Bluffs, Iowa, États-Unis, 51503
- Heartland Hematology-Oncology Associates, Inc.
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Hematology/Oncology Assoc., LLP
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Kansas
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Overland Park, Kansas, États-Unis, 66210
- Kansas City Cancer Centers - Southwest
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Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas
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Kentucky
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Danville, Kentucky, États-Unis, 40422
- Commonwealth Cancer Center
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Hazard, Kentucky, États-Unis, 41701
- Kentucky Cancer Clinic
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Paducah, Kentucky, États-Unis, 42003
- Western Kentucky Hematology and Oncology Group
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Louisiana
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Alexandria, Louisiana, États-Unis, 71301
- Christus St. Francis Cabrini Cancer Center
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Baton Rouge, Louisiana, États-Unis, 70809
- Hematology-Oncology Clinic
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Maryland
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Annapolis, Maryland, États-Unis, 21401
- Annapolis Oncology Center
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Baltimore, Maryland, États-Unis, 21204
- Greater Baltimore Medical Center
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Baltimore, Maryland, États-Unis, 21229
- St. Agnes Health Care
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Baltimore, Maryland, États-Unis, 21237
- Auerbach Hematology Oncology Associates
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Baltimore, Maryland, États-Unis, 21237
- Maryland Hematology Oncology Association
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Bethesda, Maryland, États-Unis, 20817
- Center For Cancer And Blood Disorders
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Clinton, Maryland, États-Unis, 20735
- Oncology-Hematology Associates, P.A.
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Columbia, Maryland, États-Unis, 21044
- Maryland Oncology Hematology, PA
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Westminster, Maryland, États-Unis, 21157
- Carroll County Cancer Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center
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Worcester, Massachusetts, États-Unis, 01608-1320
- Fallon Clinic at Worcester Medical Center
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Health System
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Grand Rapids, Michigan, États-Unis, 49546
- Cancer & Hematology Centers of Western Michigan
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Kalamazoo, Michigan, États-Unis, 49048
- Kalamazoo Hematology and Oncology
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Lambertville, Michigan, États-Unis, 48144
- Hematology Oncology Associates of Ohio & Michigan, PC
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Lansing, Michigan, États-Unis, 48910
- Breslin Cancer Center / Great Lakes Cancer Institute
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Southfield, Michigan, États-Unis, 48075
- Providence Cancer Center
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St. Joseph, Michigan, États-Unis, 49085
- Oncology Care Associates, P.L.L.C.
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Woodhaven, Michigan, États-Unis, 48183
- Osteopathic Medical Hematology & Oncology
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Minnesota
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Duluth, Minnesota, États-Unis, 55805
- St. Luke's Hospital
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Minneapolis, Minnesota, États-Unis, 55416
- Metro MN CCOP
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Robbinsdale, Minnesota, États-Unis, 55422
- Hubert H. Humphrey Cancer Center
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Missouri
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Chesterfield, Missouri, États-Unis, 63017
- St. Louis Cancer Center
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Jefferson City, Missouri, États-Unis, 65109
- Capital Region Medical Center/Cancer Center
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Kansas City, Missouri, États-Unis, 64118
- Heartland Hematology-Oncology Associates, Inc.
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Kansas City, Missouri, États-Unis, 64128
- Kansas City Veterans Administration Medical Center
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St. Joseph, Missouri, États-Unis, 64507
- St. Joseph Oncology
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Montana
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Great Falls, Montana, États-Unis, 59405
- Great Falls Clinic, LLP
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Nebraska
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North Platte, Nebraska, États-Unis, 69101
- Great Plains Regional Medical Center
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Omaha, Nebraska, États-Unis, 68131-2137
- Creighton Cancer Center
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Nevada
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Henderson, Nevada, États-Unis, 89052
- Las Vegas Cancer Center
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Las Vegas, Nevada, États-Unis, 89169
- Comprehensive Cancer Centers of Nevada
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New Jersey
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East Orange, New Jersey, États-Unis, 07018
- Veterans Affairs New Jersey Healthcare System
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Englewood, New Jersey, États-Unis, 07631
- Drs. Forte, Schleider, Attas and Condemi, PA
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Livingston, New Jersey, États-Unis, 07039
- St. Barnabas Medical Center
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Newark, New Jersey, États-Unis, 07112
- Newark Beth Israel Hospital
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Somerville, New Jersey, États-Unis, 08876
- Somerset Hematology Oncology Associates
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Sparta, New Jersey, États-Unis, 07871
- Sparta Cancer Center
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New Mexico
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Santa Fe, New Mexico, États-Unis, 87505
- New Mexico Cancer Care Associates
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New York
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Albany, New York, États-Unis, 12208
- Stratton VA Medical Center IRB
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Bronx, New York, États-Unis, 10469
- Eastchester Center for Cancer Care
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Buffalo, New York, États-Unis, 14215
- Erie County Medical Center
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Buffalo, New York, États-Unis, 14215
- Buffalo Institute for Medical Research, Inc.
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Goshen, New York, États-Unis, 10924
- Goshen Medical Associates
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Huntington Station, New York, États-Unis, 11746
- Huntington Medical Group
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Lake Success, New York, États-Unis, 11042
- North Shore-Long Island Jewish Health System
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New Hyde Park, New York, États-Unis, 11042
- Arena Oncology Associates
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New York, New York, États-Unis, 10021
- Memorial Sloan Kettering Cancer Center
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New York, New York, États-Unis, 10021
- New York Presbyterian Hospital-Cornell Campus
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Rochester, New York, États-Unis, 14623
- Interlakes Foundation, Inc.
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Staten Island, New York, États-Unis, 10301
- Richmond University Medical Center
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Syracuse, New York, États-Unis, 13210
- SUNY Upstate Medical University
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Valhalla, New York, États-Unis, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, États-Unis, 28801
- Cancer Care of WNC
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Burlington, North Carolina, États-Unis, 27215
- Alamance Regional Medical Center
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Fayetteville, North Carolina, États-Unis, 28304
- Blood and Cancer Clinic
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Gastonia, North Carolina, États-Unis, 28054
- Gaston Hematology & Oncology
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Hickory, North Carolina, États-Unis, 28603
- Carolina Oncology Specialist, PA
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High Point, North Carolina, États-Unis, 27262
- Emerywood Hematology/Oncology
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Raleigh, North Carolina, États-Unis, 27607
- Raleigh Hematology Oncology / Associates, P.C.
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Wilmington, North Carolina, États-Unis, 28401
- Hanover Medical Specialists, P.A.
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North Dakota
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Bismark, North Dakota, États-Unis, 58501
- St. Alexius Clinical Research Services
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Ohio
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Canton, Ohio, États-Unis, 44718
- Gabrail Cancer Center
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Cincinnati, Ohio, États-Unis, 45247
- Oncology Partners Network
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Cincinnati, Ohio, États-Unis, 45215
- Oncology Hematology Care, Inc.
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Cleveland, Ohio, États-Unis, 44106
- University Hospitals of Cleveland
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Columbus, Ohio, États-Unis, 43235
- Hematology Oncology Consultants Inc.
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Dayton, Ohio, États-Unis, 45429
- Dayton Clinical Oncology Program
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Kettering, Ohio, États-Unis, 45409
- Dayton Oncology & Hematology
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Toledo, Ohio, États-Unis, 43617
- Toledo Community Hospital Oncology Program
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Wooster, Ohio, États-Unis, 44691
- Trilogy Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73112
- Cancer Care Associates
-
Tulsa, Oklahoma, États-Unis, 74136
- Oklahoma Oncology and Hematology
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Oregon
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Eugene, Oregon, États-Unis, 97401
- Willamette Valley Cancer Center
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Pennsylvania
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Bethlehem, Pennsylvania, États-Unis, 18015
- Onc-Hem of Lehigh Valley, PC
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Dunmore, Pennsylvania, États-Unis, 18512
- Hematology & Oncology Associates of NEPA
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Kingston, Pennsylvania, États-Unis, 18704
- Medical Oncology Associates
-
Langhorne, Pennsylvania, États-Unis, 19047
- Regional Hematology Oncology Associates
-
Philadelphia, Pennsylvania, États-Unis, 19114
- Greater Philadelphia Cancer and Hematology Specialists, PC
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Pittsburgh, Pennsylvania, États-Unis, 15232
- UPMC Cancer Pavillioin
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Sayre, Pennsylvania, États-Unis, 18840
- Guthrie Research Institute
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Scranton, Pennsylvania, États-Unis, 18510
- Scranton Hematology Oncology
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Rhode Island
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Providence, Rhode Island, États-Unis, 02908
- Roger Williams Medical Center
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- MUSC Hollings Cancer Center
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Greenville, South Carolina, États-Unis, 29605
- Cancer Center Of The Carolinas
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Mt. Pleasant, South Carolina, États-Unis, 29464
- Low Country Hematology & Oncology
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Sumter, South Carolina, États-Unis, 29150
- Santee Hematology/Oncology
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57105
- Avera Research Institute
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37404
- Chattanooga Oncology Hematology Associates
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Collierville, Tennessee, États-Unis, 38017
- The Family Cancer Center, PLLC
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Cookeville, Tennessee, États-Unis, 38501
- The Cancer Center of Cookeville Regional Medical Center
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Germantown, Tennessee, États-Unis, 38138
- The Jones Clinic
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Knoxville, Tennessee, États-Unis, 37920
- East Tennessee Oncology/Hematology
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Knoxville, Tennessee, États-Unis, 37920
- University of Tennesee Medical Center
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Nashville, Tennessee, États-Unis, 37203
- Sarah Cannon Research Institute
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Texas
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Abilene, Texas, États-Unis, 79606-5208
- Texas Cancer Center
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Arlington, Texas, États-Unis, 76014
- Texas Oncology, P.A.
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Austin, Texas, États-Unis, 78705
- Southwest Regional Cancer Center
-
Austin, Texas, États-Unis, 78731
- Texas Oncology, PA
-
Beaumont, Texas, États-Unis, 77702
- Texas Oncology, PA
-
Bedford, Texas, États-Unis, 76022
- Texas Oncology, P.A.
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Corpus Christi, Texas, États-Unis, 73112
- Coastal Bend Cancer Center
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Corpus Christi, Texas, États-Unis, 78405
- South Texas Institute of Cancer and Blood Disorders
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Dallas, Texas, États-Unis, 75246
- Texas Oncology PA
-
Dallas, Texas, États-Unis, 75237
- Dallas Oncology Consultants
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Dallas, Texas, États-Unis, 75230-2510
- Texas Oncology
-
Dallas, Texas, États-Unis, 75237
- Texas Oncology, PA / Methodist Charlton Cancer Center
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Denton, Texas, États-Unis, 76210
- Texas Cancer Center
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El Paso, Texas, États-Unis, 79902
- El Paso Cancer Treatment Center
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Fort Worth, Texas, États-Unis, 76104
- Texas Cancer Center
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Garland, Texas, États-Unis, 75042
- Texas Oncology, PA
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Grapevine, Texas, États-Unis, 76051
- Lee C. Drinkard, MD
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Houston, Texas, États-Unis, 77055
- Houston Cancer Institute
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Houston, Texas, États-Unis, 77090
- Medicus Alliance Clinical Research Organization, LLC
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Lewisville, Texas, États-Unis, 75067
- Lake Vista Cancer Center
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Longview, Texas, États-Unis, 75601
- Longview Cancer Center
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Mesquite, Texas, États-Unis, 75150
- Texas Cancer Center of Mesquite
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Midland, Texas, États-Unis, 79701
- Texas Oncology, P.A.
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Odessa, Texas, États-Unis, 79761
- Texas Oncology - Odessa
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Paris, Texas, États-Unis, 75460
- Paris Regional Cancer Center
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San Antonio, Texas, États-Unis, 78217
- Cancer Care Network of South Texas
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San Antonio, Texas, États-Unis, 78229
- Cancer Care Center of South Texas
-
San Antonio, Texas, États-Unis, 78245
- CTRC Institute for Drug Development
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Sherman, Texas, États-Unis, 75090
- Texas Cancer Center - Sherman
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Tyler, Texas, États-Unis, 75701
- Blood and cancer Center of East Texas
-
Tyler, Texas, États-Unis, 75701
- Tyler Hematology/Oncology, PA
-
Tyler, Texas, États-Unis, 75702
- Texas Oncology, PA
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Waco, Texas, États-Unis, 76712
- Texas Oncology
-
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Utah
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Ogden, Utah, États-Unis, 84403
- Northern Utah Associates
-
Salt Lake City, Utah, États-Unis, 84106
- Utah Cancer Specialists
-
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Vermont
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Burlington, Vermont, États-Unis, 05401
- The University of Vermont
-
White River Junction, Vermont, États-Unis, 05009-001
- White River Junction VAMC
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Virginia
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Chesapeake, Virginia, États-Unis, 23320
- Cancer Specialists of Tidewater
-
Fairfax, Virginia, États-Unis, 22031
- Fairfax/Northern Virginia Hematology/Oncology
-
Lynchburg, Virginia, États-Unis, 24501
- Lynchburg Hematology Oncology Clinic, Inc.
-
Newport News, Virginia, États-Unis, 23601
- Peninsula Cancer Institute Riverside Cancer Center
-
Norfolk, Virginia, États-Unis, 23502
- Virginia Oncology Associates
-
Richmond, Virginia, États-Unis, 23230
- Virginia Cancer Institute
-
Salem, Virginia, États-Unis, 24153
- Oncology and Hematology Associates of Southwest Virginia, Inc.
-
Woodbridge, Virginia, États-Unis, 22191
- Masoom Kandahari, MD, PC
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Washington
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Edmonds, Washington, États-Unis, 98026
- Puget Sound Cancer Center - Edmonds
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Everett, Washington, États-Unis, 98201
- Providence Everett Medical Center
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Seattle, Washington, États-Unis, 98133
- Puget Sound Cancer Center, Inc
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Spokane, Washington, États-Unis, 99202
- Cancer Care Northwest, US Oncology
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Tacoma, Washington, États-Unis, 98405
- Northwest Medical Specialties, PLLC
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Wenatchee, Washington, États-Unis, 98801
- Wenatchee Valley Medical Center
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Yakima, Washington, États-Unis, 98902
- Yakima Valley Memorial Hospital / North Star Lodge
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Wisconsin
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La Crosse, Wisconsin, États-Unis, 54601
- Gundersen Clinic, Ltd.
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West Bend, Wisconsin, États-Unis, 53095
- Alyce & Elmore Kraemer Cancer Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Male or female 18 years of age or older
- Not a candidate for high-dose chemotherapy and stem cell transplantation (HDT/SCT) due to age, presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT-SCT, or subject preference.
- A Karnofsky Performance Status score of ≥50%
- Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage.
- Asymptomatic multiple myeloma-related organ or tissue damage can include presence of an asymptomatic lytic bone lesion or plasmacytoma, the presence of anemia (hemoglobin <10 g/dL), renal function impairment (serum creatinine > upper limit of normal [ULN]) or hypercalcemia (serum calcium >ULN).
Must have measurable disease requiring systemic therapy. Measurable disease is defined by at least 1 of the following criteria:
- Quantifiable serum M-protein value (>1 g/dL of immunoglobulin (Ig)G or IgM M-protein, >0.5g/dL of IgA M-protein, >0.5 g/dL of IgD M-protein)
- Urine light-chain excretion ≥200 mg/24 hours
- Voluntary written informed consent must be given before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Exclusion Criteria:
- Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS). Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of lytic bone lesions. MGUS is defined by presence of serum monoclonal protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
- Diagnosis of Waldenström's disease or other conditions in which immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration or lytic bone lesions.
- Previously or currently treated with any systemic therapy for multiple myeloma. Prior treatment of hypercalcemia or spinal cord compression with corticosteroids or radiation therapy, respectively, does not disqualify the subject (the dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in 2-week period).
- Radiation therapy within 2 weeks before randomization. Enrollment of patients who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 2 weeks have elapsed since the last date of therapy.
- Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery)
- History of allergy to any of the study medications, their analogues, or excipients in the various formulations
- ≥Grade 2 peripheral neuropathy on clinical examination within 21 days before enrollment.
Any of the following clinical laboratory values within 21 days prior to enrollment:
- Absolute neutrophil count (ANC) <1000 cells/mm^3
- Platelets <100,000 × 10^9/L, or <70 × 10^9/L if thrombocytopenia is considered by the investigator to be due to myeloma infiltration of bone marrow
- Aspartate aminotransferase [serum glutamic oxaloacetic transaminase] (AST [SGOT]) or alanine aminotransferase [serum glutamic-pyruvic transaminase] (ALT [SGPT]) >2× the upper limit of normal (ULN)
- Serum creatinine >2 mg/dL (>176.8 µmol/L); if the rise in creatinine is related to myeloma and there has been demonstrated a response to hydration, the subject may be enrolled.
- Myocardial infarction within 6 months prior to enrollment or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the investigator. Prior to study entry, any abnormality on electrocardiogram at screening must be determined and documented by the investigator as not medically relevant.
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study. This includes but is not limited to serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study.
- Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or other cancer for which the patient has been disease-free for at least 3 years.
- Female who is pregnant or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test with a sensitivity of at least 50 mIU/mL during Screening.
- Use of any investigational drugs within 30 days before randomization.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Bortezomib and Dexamethasone (VD)
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction).
Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
|
Bortezomib bolus intravenous (IV) injection
Autres noms:
Dexamethasone for oral administration
|
|
Expérimental: Bortezomib, Thalidomide, and Dexamethasone (VTD)
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction).
Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance) .
|
Bortezomib bolus intravenous (IV) injection
Autres noms:
Dexamethasone for oral administration
Thalidomide for oral administration
|
|
Expérimental: Bortezomib, Melphalan and Prednisone (VMP)
Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction).
Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
|
Bortezomib bolus intravenous (IV) injection
Autres noms:
Melphalan for oral administration
Prednisone for oral administration
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression Free Survival (PFS)
Délai: From randomization until disease progression. Median follow-up time was 43 months.
|
PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria. Progressive disease requires 1 of the following:
|
From randomization until disease progression. Median follow-up time was 43 months.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With an Overall Response
Délai: Response assessed every other cycle for up to 13 cycles (49 weeks).
|
Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria. CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h). PR requires 1 of the following:
If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required. |
Response assessed every other cycle for up to 13 cycles (49 weeks).
|
|
Percentage of Participants With a Complete Response
Délai: Response assessed every other cycle, for up to 13 cycles (49 weeks).
|
Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.
Response was assessed by the Investigator using the IMWG uniform response criteria.
|
Response assessed every other cycle, for up to 13 cycles (49 weeks).
|
|
Percentage of Participants With a Complete Response or a Very Good Partial Response
Délai: Response assessed every other cycle for up to 13 cycles (49 weeks).
|
Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. Response was assessed by the Investigator using the IMWG uniform response criteria. |
Response assessed every other cycle for up to 13 cycles (49 weeks).
|
|
Duration of Response
Délai: From first documented response until disease progression. Median follow-up time was 43 months.
|
Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression.
Responders without disease progression were censored at the last clinical assessment of response.
|
From first documented response until disease progression. Median follow-up time was 43 months.
|
|
Overall Survival
Délai: From randomization until death. Median follow-up time was 43 months.
|
Overall survival is defined as the time between randomization and death.
Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.
|
From randomization until death. Median follow-up time was 43 months.
|
|
Time to Alternative Therapy
Délai: From randomization until alternative therapy. Median follow-up time was 43 months.
|
Time to alternative therapy is defined as the time between randomization and alternative therapy.
Participants who did not receive alternative therapy were censored at the time of last contact.
|
From randomization until alternative therapy. Median follow-up time was 43 months.
|
|
Change From Baseline in EORTC QLQ-C30 - Global Health Status
Délai: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13
|
The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. |
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2007
Achèvement primaire (Réel)
1 mars 2013
Achèvement de l'étude (Réel)
1 mars 2013
Dates d'inscription aux études
Première soumission
25 juillet 2007
Première soumission répondant aux critères de contrôle qualité
25 juillet 2007
Première publication (Estimation)
26 juillet 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 mai 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 mars 2014
Dernière vérification
1 mars 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Maladies hématologiques
- Troubles hémorragiques
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Myélome multiple
- Tumeurs, plasmocyte
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents autonomes
- Agents du système nerveux périphérique
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Antiémétiques
- Agents gastro-intestinaux
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Agents antibactériens
- Agents léprostatiques
- Dexaméthasone
- Thalidomide
- Prednisone
- Melphalan
- Bortézomib
Autres numéros d'identification d'étude
- C05009
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Bortezomib
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Columbia UniversityInconnueMésothéliomeÉtats-Unis
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Zhongnan HospitalRecrutementLeucémie myéloïde aiguë | BortézomibChine
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Fondazione Italiana Linfomi ONLUSComplétéMacroglobulinémie de WaldenströmItalie
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First Affiliated Hospital, Sun Yat-Sen UniversitySecond Affiliated Hospital of Guangzhou Medical UniversityInconnue
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King Faisal Specialist Hospital & Research CenterComplété