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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00507416
First received: July 25, 2007
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Drug: Dexamethasone
Drug: Melphalan
Drug: Prednisone
Drug: Thalidomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: From randomization until disease progression. Median follow-up time was 43 months. ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Percentage of Participants With an Overall Response [ Time Frame: Response assessed every other cycle for up to 13 cycles (49 weeks). ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With a Complete Response [ Time Frame: Response assessed every other cycle, for up to 13 cycles (49 weeks). ] [ Designated as safety issue: No ]
    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.

  • 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). ] [ Designated as safety issue: No ]

    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.


  • Duration of Response [ Time Frame: From first documented response until disease progression. Median follow-up time was 43 months. ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: From randomization until death. Median follow-up time was 43 months. ] [ Designated as safety issue: No ]
    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.

  • Time to Alternative Therapy [ Time Frame: From randomization until alternative therapy. Median follow-up time was 43 months. ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 502
Study Start Date: June 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Velcade
Drug: Melphalan
Melphalan for oral administration
Drug: Prednisone
Prednisone for oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507416

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

Additional Information:
No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00507416     History of Changes
Other Study ID Numbers: C05009
Study First Received: July 25, 2007
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Dexamethasone 21-phosphate
Bortezomib
Melphalan
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014