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Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone (UPFRONT)

28. března 2014 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

502

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Portoriko
      • San Juan, Portoriko, 00919-1227
        • Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35205
        • Birmingham Hematology Oncology Assciates, LLC
    • Arizona
      • Casa Grande, Arizona, Spojené státy, 85222
        • Desert Oasis Cancer Center
      • Sedona, Arizona, Spojené státy, 86336
        • Northern Arizona Hematology & Oncology Associates - AOA
      • Tucson, Arizona, Spojené státy, 85704
        • Arizona Oncology Associates
    • Arkansas
      • Hot Springs, Arkansas, Spojené státy, 71913
        • Heritage Physician Group Oncology
      • Little Rock, Arkansas, Spojené státy, 72205
        • Hematology Oncology Services of Arkansas
    • California
      • Anaheim, California, Spojené státy, 92801
        • Pacific Cancer Medical Centre
      • Beverly Hills, California, Spojené státy, 90211-1850
        • Tower Cancer Research Foundation
      • Corona, California, Spojené státy, 92882
        • Compassionate Cancer Care Medical Group
      • Fountain Valley, California, Spojené státy, 92708
        • Robert A. Moss, MD, FACP, Inc.
      • Fountain Valley, California, Spojené státy, 92708
        • Compassionate Cancer Care Medical Group, Inc.
      • Fresno, California, Spojené státy, 93720
        • Cancer Care Associates
      • Glendale, California, Spojené státy, 91204
        • Glendale Memorial Hospital & Health Center
      • Greenbrae, California, Spojené státy, 94904
        • California Cancer Care
      • Highland, California, Spojené státy, 92346
        • Beaver Medical Group
      • Laguna Beach, California, Spojené státy, 92882
        • Edward A. Wagner, MD
      • Montebello, California, Spojené státy, 90640
        • Clinical Trials and Research Associates, Inc.
      • Orange, California, Spojené státy, 92868
        • Medical Oncology Care Associates
      • Oxnard, California, Spojené státy, 93030
        • Ventura County Hematology Oncology Specialists
      • Poway, California, Spojené státy, 92064
        • Southwest Cancer Care
      • Rancho Mirage, California, Spojené státy, 92270
        • Desert Cancer Care, Incorporated
      • Riverside, California, Spojené státy, 92501
        • Compassionate Cancer Care Medical Group, Inc.
      • Sacramento, California, Spojené státy, 95816
        • Sutter Cancer center
      • Soquel, California, Spojené státy, 95073
        • Cancer Research & Prevention Center
      • Stockton, California, Spojené státy, 95204
        • Stockton Hematology/Oncology
      • Westlake Village, California, Spojené státy, 91361
        • Trivalley Oncology Hematology
    • Colorado
      • Denver, Colorado, Spojené státy, 80218
        • Rocky Mountain Cancer Center
    • Connecticut
      • Southington, Connecticut, Spojené státy, 06489
        • Cancer Center of Central Connecticut
    • Delaware
      • Newark, Delaware, Spojené státy, 19718
        • Christiana Care Health Services
    • Florida
      • Boca Raton, Florida, Spojené státy, 33486
        • The Center for Hematology-Oncology
      • Brooksville, Florida, Spojené státy, 34613
        • Pasco Hernando Oncology
      • Coral Springs, Florida, Spojené státy, 33065
        • Northwest Oncology & Hematology Associates
      • Fort Myers, Florida, Spojené státy, 33901
        • Florida Cancer Specialists
      • Hollywood, Florida, Spojené státy, 33021
        • Horizon Institute for Clinical Research
      • Jacksonville, Florida, Spojené státy, 32207
        • Baptist Cancer Institute
      • Jacksonville, Florida, Spojené státy, 32209
        • University of Florida- Jacksonville
      • Lake City, Florida, Spojené státy, 32024
        • Cancer Care of North Florida
      • Lakeland, Florida, Spojené státy, 33805
        • Lakeland Regional Cancer Center
      • Lecanto, Florida, Spojené státy, 34461
        • Cancer & Blood Disease Center
      • New Port Richey, Florida, Spojené státy, 34655
        • Florida Cancer Institute
      • New Port Richey, Florida, Spojené státy, 34652
        • Pasco Hernando Oncology
      • North Miami Beach, Florida, Spojené státy, 33179
        • Innovative Medical Research of South Florida Inc.
      • Ocala, Florida, Spojené státy, 34474
        • Ocala Oncology Center
      • Ocoee, Florida, Spojené státy, 34761
        • Cancer Centers of Florida, P.A.
      • Orlando, Florida, Spojené státy, 32806
        • MD Anderson Cancer Center Orlando
      • Port St. Lucie, Florida, Spojené státy, 34952
        • Hematology Oncology Associates of the Treasure Coast, PA
      • St. Petersburg, Florida, Spojené státy, 33705
        • Gulfcoast Oncology Associates
      • West Palm Beach, Florida, Spojené státy, 33458
        • S. Florida Oncology/ Hematology
    • Georgia
      • Augusta, Georgia, Spojené státy, 30901
        • Medical Oncology Associates of Augusta
      • Macon, Georgia, Spojené státy, 31201
        • Central Georgia Cancer Care
      • Marietta, Georgia, Spojené státy, 30060
        • Northwest Georgia Oncology Centers, P.C.
      • Savannah, Georgia, Spojené státy, 31405
        • Summit Cancer Care
    • Idaho
      • Boise, Idaho, Spojené státy, 83712
        • St. Lukes Mountain States Tumor Institute
      • Idaho Falls, Idaho, Spojené státy, 83404
        • Snake River Oncology of Eastern Idaho, PLLC.
    • Illinois
      • Arlington Heights, Illinois, Spojené státy, 60005
        • Cancer Care & Hematology Specialists of Chicagoland
      • Chicago, Illinois, Spojené státy, 60637
        • University of Chicago
      • Chicago, Illinois, Spojené státy, 60612
        • John H. Stroger, Jr. Hospital of Cook County
      • Chicago, Illinois, Spojené státy, 60611
        • Hematology Oncology Associates of Illinois
      • Chicago, Illinois, Spojené státy, 60657
        • Hematology Oncology Associates of Illinois
      • Elmhurst, Illinois, Spojené státy, 60126
        • Elmhurst Memorial Hospital
      • Gurnee, Illinois, Spojené státy, 60031-3399
        • Oncology Hematology Associates of North Illinois Ltd.
      • Joliet, Illinois, Spojené státy, 60435
        • Joliet Oncology-Hematology Associates, Ltd.
      • Joliet, Illinois, Spojené státy, 60432
        • Midwest Center for Hematology / Oncology
      • Naperville, Illinois, Spojené státy, 60540
        • Hematology Oncology Consultants, Inc.
      • Niles, Illinois, Spojené státy, 60714
        • Cancer Care and Hematology Specialists of Chicagoland
      • Normal, Illinois, Spojené státy, 61761
        • Mid-Illinois Hem & Onc
      • Quincy, Illinois, Spojené státy, 62301
        • Quincy Medical Group
    • Indiana
      • Evansville, Indiana, Spojené státy, 47713
        • Deaconess Clinic Incorporated
      • Indianapolis, Indiana, Spojené státy, 46227
        • Central Indiana Cancer Centers
      • Indianapolis, Indiana, Spojené státy, 46254
        • Investigative Clinical Research of Indiana, LLC
      • Lafayette, Indiana, Spojené státy, 47904
        • Clarian Arnett Cancer Center
      • Muncie, Indiana, Spojené státy, 47303
        • Medical Consultants, Pc
      • New Albany, Indiana, Spojené státy, 47150
        • Cancer Care Center
      • South Bend, Indiana, Spojené státy, 46601
        • Memorial Hospital of South Bend
      • Terre Haute, Indiana, Spojené státy, 47802
        • Hope Center
    • Iowa
      • Ames, Iowa, Spojené státy, 50010
        • McFarland Clinic, P.C.
      • Council Bluffs, Iowa, Spojené státy, 51503
        • Heartland Hematology-Oncology Associates, Inc.
      • Sioux City, Iowa, Spojené státy, 51101
        • Siouxland Hematology/Oncology Assoc., LLP
    • Kansas
      • Overland Park, Kansas, Spojené státy, 66210
        • Kansas City Cancer Centers - Southwest
      • Wichita, Kansas, Spojené státy, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Danville, Kentucky, Spojené státy, 40422
        • Commonwealth Cancer Center
      • Hazard, Kentucky, Spojené státy, 41701
        • Kentucky Cancer Clinic
      • Paducah, Kentucky, Spojené státy, 42003
        • Western Kentucky Hematology and Oncology Group
    • Louisiana
      • Alexandria, Louisiana, Spojené státy, 71301
        • Christus St. Francis Cabrini Cancer Center
      • Baton Rouge, Louisiana, Spojené státy, 70809
        • Hematology-Oncology Clinic
    • Maryland
      • Annapolis, Maryland, Spojené státy, 21401
        • Annapolis Oncology Center
      • Baltimore, Maryland, Spojené státy, 21204
        • Greater Baltimore Medical Center
      • Baltimore, Maryland, Spojené státy, 21229
        • St. Agnes Health Care
      • Baltimore, Maryland, Spojené státy, 21237
        • Auerbach Hematology Oncology Associates
      • Baltimore, Maryland, Spojené státy, 21237
        • Maryland Hematology Oncology Association
      • Bethesda, Maryland, Spojené státy, 20817
        • Center For Cancer And Blood Disorders
      • Clinton, Maryland, Spojené státy, 20735
        • Oncology-Hematology Associates, P.A.
      • Columbia, Maryland, Spojené státy, 21044
        • Maryland Oncology Hematology, PA
      • Westminster, Maryland, Spojené státy, 21157
        • Carroll County Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02118
        • Boston Medical Center
      • Worcester, Massachusetts, Spojené státy, 01608-1320
        • Fallon Clinic at Worcester Medical Center
    • Michigan
      • Detroit, Michigan, Spojené státy, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, Spojené státy, 49546
        • Cancer & Hematology Centers of Western Michigan
      • Kalamazoo, Michigan, Spojené státy, 49048
        • Kalamazoo Hematology and Oncology
      • Lambertville, Michigan, Spojené státy, 48144
        • Hematology Oncology Associates of Ohio & Michigan, PC
      • Lansing, Michigan, Spojené státy, 48910
        • Breslin Cancer Center / Great Lakes Cancer Institute
      • Southfield, Michigan, Spojené státy, 48075
        • Providence Cancer Center
      • St. Joseph, Michigan, Spojené státy, 49085
        • Oncology Care Associates, P.L.L.C.
      • Woodhaven, Michigan, Spojené státy, 48183
        • Osteopathic Medical Hematology & Oncology
    • Minnesota
      • Duluth, Minnesota, Spojené státy, 55805
        • St. Luke's Hospital
      • Minneapolis, Minnesota, Spojené státy, 55416
        • Metro MN CCOP
      • Robbinsdale, Minnesota, Spojené státy, 55422
        • Hubert H. Humphrey Cancer Center
    • Missouri
      • Chesterfield, Missouri, Spojené státy, 63017
        • St. Louis Cancer Center
      • Jefferson City, Missouri, Spojené státy, 65109
        • Capital Region Medical Center/Cancer Center
      • Kansas City, Missouri, Spojené státy, 64118
        • Heartland Hematology-Oncology Associates, Inc.
      • Kansas City, Missouri, Spojené státy, 64128
        • Kansas City Veterans Administration Medical Center
      • St. Joseph, Missouri, Spojené státy, 64507
        • St. Joseph Oncology
    • Montana
      • Great Falls, Montana, Spojené státy, 59405
        • Great Falls Clinic, LLP
    • Nebraska
      • North Platte, Nebraska, Spojené státy, 69101
        • Great Plains Regional Medical Center
      • Omaha, Nebraska, Spojené státy, 68131-2137
        • Creighton Cancer Center
    • Nevada
      • Henderson, Nevada, Spojené státy, 89052
        • Las Vegas Cancer Center
      • Las Vegas, Nevada, Spojené státy, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • East Orange, New Jersey, Spojené státy, 07018
        • Veterans Affairs New Jersey Healthcare System
      • Englewood, New Jersey, Spojené státy, 07631
        • Drs. Forte, Schleider, Attas and Condemi, PA
      • Livingston, New Jersey, Spojené státy, 07039
        • St. Barnabas Medical Center
      • Newark, New Jersey, Spojené státy, 07112
        • Newark Beth Israel Hospital
      • Somerville, New Jersey, Spojené státy, 08876
        • Somerset Hematology Oncology Associates
      • Sparta, New Jersey, Spojené státy, 07871
        • Sparta Cancer Center
    • New Mexico
      • Santa Fe, New Mexico, Spojené státy, 87505
        • New Mexico Cancer Care Associates
    • New York
      • Albany, New York, Spojené státy, 12208
        • Stratton VA Medical Center IRB
      • Bronx, New York, Spojené státy, 10469
        • Eastchester Center for Cancer Care
      • Buffalo, New York, Spojené státy, 14215
        • Erie County Medical Center
      • Buffalo, New York, Spojené státy, 14215
        • Buffalo Institute for Medical Research, Inc.
      • Goshen, New York, Spojené státy, 10924
        • Goshen Medical Associates
      • Huntington Station, New York, Spojené státy, 11746
        • Huntington Medical Group
      • Lake Success, New York, Spojené státy, 11042
        • North Shore-Long Island Jewish Health System
      • New Hyde Park, New York, Spojené státy, 11042
        • Arena Oncology Associates
      • New York, New York, Spojené státy, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Spojené státy, 10021
        • New York Presbyterian Hospital-Cornell Campus
      • Rochester, New York, Spojené státy, 14623
        • Interlakes Foundation, Inc.
      • Staten Island, New York, Spojené státy, 10301
        • Richmond University Medical Center
      • Syracuse, New York, Spojené státy, 13210
        • SUNY Upstate Medical University
      • Valhalla, New York, Spojené státy, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, Spojené státy, 28801
        • Cancer Care of WNC
      • Burlington, North Carolina, Spojené státy, 27215
        • Alamance Regional Medical Center
      • Fayetteville, North Carolina, Spojené státy, 28304
        • Blood and Cancer Clinic
      • Gastonia, North Carolina, Spojené státy, 28054
        • Gaston Hematology & Oncology
      • Hickory, North Carolina, Spojené státy, 28603
        • Carolina Oncology Specialist, PA
      • High Point, North Carolina, Spojené státy, 27262
        • Emerywood Hematology/Oncology
      • Raleigh, North Carolina, Spojené státy, 27607
        • Raleigh Hematology Oncology / Associates, P.C.
      • Wilmington, North Carolina, Spojené státy, 28401
        • Hanover Medical Specialists, P.A.
    • North Dakota
      • Bismark, North Dakota, Spojené státy, 58501
        • St. Alexius Clinical Research Services
    • Ohio
      • Canton, Ohio, Spojené státy, 44718
        • Gabrail Cancer Center
      • Cincinnati, Ohio, Spojené státy, 45247
        • Oncology Partners Network
      • Cincinnati, Ohio, Spojené státy, 45215
        • Oncology Hematology Care, Inc.
      • Cleveland, Ohio, Spojené státy, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, Spojené státy, 43235
        • Hematology Oncology Consultants Inc.
      • Dayton, Ohio, Spojené státy, 45429
        • Dayton Clinical Oncology Program
      • Kettering, Ohio, Spojené státy, 45409
        • Dayton Oncology & Hematology
      • Toledo, Ohio, Spojené státy, 43617
        • Toledo Community Hospital Oncology Program
      • Wooster, Ohio, Spojené státy, 44691
        • Trilogy Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73112
        • Cancer Care Associates
      • Tulsa, Oklahoma, Spojené státy, 74136
        • Oklahoma Oncology and Hematology
    • Oregon
      • Eugene, Oregon, Spojené státy, 97401
        • Willamette Valley Cancer Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, Spojené státy, 18015
        • Onc-Hem of Lehigh Valley, PC
      • Dunmore, Pennsylvania, Spojené státy, 18512
        • Hematology & Oncology Associates of NEPA
      • Kingston, Pennsylvania, Spojené státy, 18704
        • Medical Oncology Associates
      • Langhorne, Pennsylvania, Spojené státy, 19047
        • Regional Hematology Oncology Associates
      • Philadelphia, Pennsylvania, Spojené státy, 19114
        • Greater Philadelphia Cancer and Hematology Specialists, PC
      • Pittsburgh, Pennsylvania, Spojené státy, 15232
        • UPMC Cancer Pavillioin
      • Sayre, Pennsylvania, Spojené státy, 18840
        • Guthrie Research Institute
      • Scranton, Pennsylvania, Spojené státy, 18510
        • Scranton Hematology Oncology
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02908
        • Roger Williams Medical Center
    • South Carolina
      • Charleston, South Carolina, Spojené státy, 29425
        • MUSC Hollings Cancer Center
      • Greenville, South Carolina, Spojené státy, 29605
        • Cancer Center Of The Carolinas
      • Mt. Pleasant, South Carolina, Spojené státy, 29464
        • Low Country Hematology & Oncology
      • Sumter, South Carolina, Spojené státy, 29150
        • Santee Hematology/Oncology
    • South Dakota
      • Sioux Falls, South Dakota, Spojené státy, 57105
        • Avera Research Institute
    • Tennessee
      • Chattanooga, Tennessee, Spojené státy, 37404
        • Chattanooga Oncology Hematology Associates
      • Collierville, Tennessee, Spojené státy, 38017
        • The Family Cancer Center, PLLC
      • Cookeville, Tennessee, Spojené státy, 38501
        • The Cancer Center of Cookeville Regional Medical Center
      • Germantown, Tennessee, Spojené státy, 38138
        • The Jones Clinic
      • Knoxville, Tennessee, Spojené státy, 37920
        • East Tennessee Oncology/Hematology
      • Knoxville, Tennessee, Spojené státy, 37920
        • University of Tennesee Medical Center
      • Nashville, Tennessee, Spojené státy, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Abilene, Texas, Spojené státy, 79606-5208
        • Texas Cancer Center
      • Arlington, Texas, Spojené státy, 76014
        • Texas Oncology, P.A.
      • Austin, Texas, Spojené státy, 78705
        • Southwest Regional Cancer Center
      • Austin, Texas, Spojené státy, 78731
        • Texas Oncology, PA
      • Beaumont, Texas, Spojené státy, 77702
        • Texas Oncology, PA
      • Bedford, Texas, Spojené státy, 76022
        • Texas Oncology, P.A.
      • Corpus Christi, Texas, Spojené státy, 73112
        • Coastal Bend Cancer Center
      • Corpus Christi, Texas, Spojené státy, 78405
        • South Texas Institute of Cancer and Blood Disorders
      • Dallas, Texas, Spojené státy, 75246
        • Texas Oncology PA
      • Dallas, Texas, Spojené státy, 75237
        • Dallas Oncology Consultants
      • Dallas, Texas, Spojené státy, 75230-2510
        • Texas Oncology
      • Dallas, Texas, Spojené státy, 75237
        • Texas Oncology, PA / Methodist Charlton Cancer Center
      • Denton, Texas, Spojené státy, 76210
        • Texas Cancer Center
      • El Paso, Texas, Spojené státy, 79902
        • El Paso Cancer Treatment Center
      • Fort Worth, Texas, Spojené státy, 76104
        • Texas Cancer Center
      • Garland, Texas, Spojené státy, 75042
        • Texas Oncology, PA
      • Grapevine, Texas, Spojené státy, 76051
        • Lee C. Drinkard, MD
      • Houston, Texas, Spojené státy, 77055
        • Houston Cancer Institute
      • Houston, Texas, Spojené státy, 77090
        • Medicus Alliance Clinical Research Organization, LLC
      • Lewisville, Texas, Spojené státy, 75067
        • Lake Vista Cancer Center
      • Longview, Texas, Spojené státy, 75601
        • Longview Cancer Center
      • Mesquite, Texas, Spojené státy, 75150
        • Texas Cancer Center of Mesquite
      • Midland, Texas, Spojené státy, 79701
        • Texas Oncology, P.A.
      • Odessa, Texas, Spojené státy, 79761
        • Texas Oncology - Odessa
      • Paris, Texas, Spojené státy, 75460
        • Paris Regional Cancer Center
      • San Antonio, Texas, Spojené státy, 78217
        • Cancer Care Network of South Texas
      • San Antonio, Texas, Spojené státy, 78229
        • Cancer Care Center of South Texas
      • San Antonio, Texas, Spojené státy, 78245
        • CTRC Institute for Drug Development
      • Sherman, Texas, Spojené státy, 75090
        • Texas Cancer Center - Sherman
      • Tyler, Texas, Spojené státy, 75701
        • Blood and Cancer Center of East Texas
      • Tyler, Texas, Spojené státy, 75701
        • Tyler Hematology/Oncology, PA
      • Tyler, Texas, Spojené státy, 75702
        • Texas Oncology, PA
      • Waco, Texas, Spojené státy, 76712
        • Texas Oncology
    • Utah
      • Ogden, Utah, Spojené státy, 84403
        • Northern Utah Associates
      • Salt Lake City, Utah, Spojené státy, 84106
        • Utah Cancer Specialists
    • Vermont
      • Burlington, Vermont, Spojené státy, 05401
        • The University of Vermont
      • White River Junction, Vermont, Spojené státy, 05009-001
        • White River Junction VAMC
    • Virginia
      • Chesapeake, Virginia, Spojené státy, 23320
        • Cancer Specialists of Tidewater
      • Fairfax, Virginia, Spojené státy, 22031
        • Fairfax/Northern Virginia Hematology/Oncology
      • Lynchburg, Virginia, Spojené státy, 24501
        • Lynchburg Hematology Oncology Clinic, Inc.
      • Newport News, Virginia, Spojené státy, 23601
        • Peninsula Cancer Institute Riverside Cancer Center
      • Norfolk, Virginia, Spojené státy, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, Spojené státy, 23230
        • Virginia Cancer Institute
      • Salem, Virginia, Spojené státy, 24153
        • Oncology and Hematology Associates of Southwest Virginia, Inc.
      • Woodbridge, Virginia, Spojené státy, 22191
        • Masoom Kandahari, MD, PC
    • Washington
      • Edmonds, Washington, Spojené státy, 98026
        • Puget Sound Cancer Center - Edmonds
      • Everett, Washington, Spojené státy, 98201
        • Providence Everett Medical Center
      • Seattle, Washington, Spojené státy, 98133
        • Puget Sound Cancer Center, Inc
      • Spokane, Washington, Spojené státy, 99202
        • Cancer Care Northwest, US Oncology
      • Tacoma, Washington, Spojené státy, 98405
        • Northwest Medical Specialties, PLLC
      • Wenatchee, Washington, Spojené státy, 98801
        • Wenatchee Valley Medical Center
      • Yakima, Washington, Spojené státy, 98902
        • Yakima Valley Memorial Hospital / North Star Lodge
    • Wisconsin
      • La Crosse, Wisconsin, Spojené státy, 54601
        • Gundersen Clinic, Ltd.
      • West Bend, Wisconsin, Spojené státy, 53095
        • Alyce & Elmore Kraemer Cancer Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Lék: Bortezomib
Bortezomib bolus intravenous (IV) injection
Ostatní jména:
  • Velcade
Lék: Dexamethasone
Dexamethasone for oral administration
Experimentální: 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) .
Lék: Bortezomib
Bortezomib bolus intravenous (IV) injection
Ostatní jména:
  • Velcade
Lék: Dexamethasone
Dexamethasone for oral administration
Lék: Thalidomide
Thalidomide for oral administration
Experimentální: 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).
Lék: Bortezomib
Bortezomib bolus intravenous (IV) injection
Ostatní jména:
  • Velcade
Lék: Melphalan
Melphalan for oral administration
Lék: Prednisone
Prednisone for oral administration

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression Free Survival (PFS)
Časové okno: 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:

  • Increase of ≥ 25% from nadir in:

    • Serum M-component (absolute increase ≥ 0.5 g/dl)
    • Urine M-component (absolute increase ≥ 200 mg/24 hours)
    • In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
    • Bone marrow plasma cell percentage (absolute % ≥ 10%)
  • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
  • Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease
From randomization until disease progression. Median follow-up time was 43 months.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With an Overall Response
Časové okno: 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:

  • ≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or
  • If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or
  • If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.

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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Millennium Pharmaceuticals, Inc.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. června 2007

Primární dokončení (Aktuální)

1. března 2013

Dokončení studie (Aktuální)

1. března 2013

Termíny zápisu do studia

První předloženo

25. července 2007

První předloženo, které splnilo kritéria kontroly kvality

25. července 2007

První zveřejněno (Odhad)

26. července 2007

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

1. května 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. března 2014

Naposledy ověřeno

1. března 2014

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C05009

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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