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

March 28, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

502

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Bortezomib
Bortezomib bolus intravenous (IV) injection
Other Names:
  • Velcade
Drug: Dexamethasone
Dexamethasone for oral administration
Experimental: 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) .
Drug: Bortezomib
Bortezomib bolus intravenous (IV) injection
Other Names:
  • Velcade
Drug: Dexamethasone
Dexamethasone for oral administration
Drug: Thalidomide
Thalidomide for oral administration
Experimental: 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).
Drug: Bortezomib
Bortezomib bolus intravenous (IV) injection
Other Names:
  • Velcade
Drug: Melphalan
Melphalan for oral administration
Drug: Prednisone
Prednisone for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an Overall Response
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 25, 2007

First Submitted That Met QC Criteria

July 25, 2007

First Posted (Estimate)

July 26, 2007

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C05009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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