Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone
UPFRONT
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
1 other identifier
interventional
502
2 countries
235
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Jun 2007
235 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 25, 2007
CompletedFirst Posted
Study publicly available on registry
July 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
May 1, 2014
CompletedMay 1, 2014
March 1, 2014
5.8 years
July 25, 2007
March 28, 2014
March 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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 Outcomes (7)
Percentage of Participants With an Overall Response
Response assessed every other cycle for up to 13 cycles (49 weeks).
Percentage of Participants With a Complete Response
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
Response assessed every other cycle for up to 13 cycles (49 weeks).
Duration of Response
From first documented response until disease progression. Median follow-up time was 43 months.
Overall Survival
From randomization until death. Median follow-up time was 43 months.
- +2 more secondary outcomes
Study Arms (3)
Bortezomib and Dexamethasone (VD)
EXPERIMENTALParticipants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Thalidomide, and Dexamethasone (VTD)
EXPERIMENTALParticipants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance) .
Bortezomib, Melphalan and Prednisone (VMP)
EXPERIMENTALParticipants 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).
Interventions
Bortezomib bolus intravenous (IV) injection
Dexamethasone for oral administration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (235)
Birmingham Hematology Oncology Assciates, LLC
Birmingham, Alabama, 35205, United States
Desert Oasis Cancer Center
Casa Grande, Arizona, 85222, United States
Northern Arizona Hematology & Oncology Associates - AOA
Sedona, Arizona, 86336, United States
Arizona Oncology Associates
Tucson, Arizona, 85704, United States
Heritage Physician Group Oncology
Hot Springs, Arkansas, 71913, United States
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205, United States
Pacific Cancer Medical Centre
Anaheim, California, 92801, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
Compassionate Cancer Care Medical Group
Corona, California, 92882, United States
Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708, United States
Robert A. Moss, MD, FACP, Inc.
Fountain Valley, California, 92708, United States
Cancer Care Associates
Fresno, California, 93720, United States
Glendale Memorial Hospital & Health Center
Glendale, California, 91204, United States
California Cancer Care
Greenbrae, California, 94904, United States
Beaver Medical Group
Highland, California, 92346, United States
Edward A. Wagner, MD
Laguna Beach, California, 92882, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
Medical Oncology Care Associates
Orange, California, 92868, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Southwest Cancer Care
Poway, California, 92064, United States
Desert Cancer Care, Incorporated
Rancho Mirage, California, 92270, United States
Compassionate Cancer Care Medical Group, Inc.
Riverside, California, 92501, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
Cancer Research & Prevention Center
Soquel, California, 95073, United States
Stockton Hematology/Oncology
Stockton, California, 95204, United States
Trivalley Oncology Hematology
Westlake Village, California, 91361, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Cancer Center of Central Connecticut
Southington, Connecticut, 06489, United States
Christiana Care Health Services
Newark, Delaware, 19718, United States
The Center for Hematology-Oncology
Boca Raton, Florida, 33486, United States
Pasco Hernando Oncology
Brooksville, Florida, 34613, United States
Northwest Oncology & Hematology Associates
Coral Springs, Florida, 33065, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Horizon Institute for Clinical Research
Hollywood, Florida, 33021, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
University of Florida- Jacksonville
Jacksonville, Florida, 32209, United States
Cancer Care of North Florida
Lake City, Florida, 32024, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Cancer & Blood Disease Center
Lecanto, Florida, 34461, United States
Pasco Hernando Oncology
New Port Richey, Florida, 34652, United States
Florida Cancer Institute
New Port Richey, Florida, 34655, United States
Innovative Medical Research of South Florida Inc.
North Miami Beach, Florida, 33179, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Hematology Oncology Associates of the Treasure Coast, PA
Port Saint Lucie, Florida, 34952, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
S. Florida Oncology/ Hematology
West Palm Beach, Florida, 33458, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Central Georgia Cancer Care
Macon, Georgia, 31201, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060, United States
Summit Cancer Care
Savannah, Georgia, 31405, United States
St. Lukes Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Snake River Oncology of Eastern Idaho, PLLC.
Idaho Falls, Idaho, 83404, United States
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois, 60005, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60611, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60657, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Oncology Hematology Associates of North Illinois Ltd.
Gurnee, Illinois, 60031-3399, United States
Midwest Center for Hematology / Oncology
Joliet, Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435, United States
Hematology Oncology Consultants, Inc.
Naperville, Illinois, 60540, United States
Cancer Care and Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Mid-Illinois Hem & Onc
Normal, Illinois, 61761, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Deaconess Clinic Incorporated
Evansville, Indiana, 47713, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46254, United States
Clarian Arnett Cancer Center
Lafayette, Indiana, 47904, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
Cancer Care Center
New Albany, Indiana, 47150, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Hope Center
Terre Haute, Indiana, 47802, United States
McFarland Clinic, P.C.
Ames, Iowa, 50010, United States
Heartland Hematology-Oncology Associates, Inc.
Council Bluffs, Iowa, 51503, United States
Siouxland Hematology/Oncology Assoc., LLP
Sioux City, Iowa, 51101, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Commonwealth Cancer Center
Danville, Kentucky, 40422, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Western Kentucky Hematology and Oncology Group
Paducah, Kentucky, 42003, United States
Christus St. Francis Cabrini Cancer Center
Alexandria, Louisiana, 71301, United States
Hematology-Oncology Clinic
Baton Rouge, Louisiana, 70809, United States
Annapolis Oncology Center
Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
St. Agnes Health Care
Baltimore, Maryland, 21229, United States
Auerbach Hematology Oncology Associates
Baltimore, Maryland, 21237, United States
Maryland Hematology Oncology Association
Baltimore, Maryland, 21237, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, 21044, United States
Carroll County Cancer Center
Westminster, Maryland, 21157, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, 01608-1320, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, 49048, United States
Hematology Oncology Associates of Ohio & Michigan, PC
Lambertville, Michigan, 48144, United States
Breslin Cancer Center / Great Lakes Cancer Institute
Lansing, Michigan, 48910, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085, United States
Providence Cancer Center
Southfield, Michigan, 48075, United States
Osteopathic Medical Hematology & Oncology
Woodhaven, Michigan, 48183, United States
St. Luke's Hospital
Duluth, Minnesota, 55805, United States
Metro MN CCOP
Minneapolis, Minnesota, 55416, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
St. Louis Cancer Center
Chesterfield, Missouri, 63017, United States
Capital Region Medical Center/Cancer Center
Jefferson City, Missouri, 65109, United States
Heartland Hematology-Oncology Associates, Inc.
Kansas City, Missouri, 64118, United States
Kansas City Veterans Administration Medical Center
Kansas City, Missouri, 64128, United States
St. Joseph Oncology
Saint Joseph, Missouri, 64507, United States
Great Falls Clinic, LLP
Great Falls, Montana, 59405, United States
Great Plains Regional Medical Center
North Platte, Nebraska, 69101, United States
Creighton Cancer Center
Omaha, Nebraska, 68131-2137, United States
Las Vegas Cancer Center
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Veterans Affairs New Jersey Healthcare System
East Orange, New Jersey, 07018, United States
Drs. Forte, Schleider, Attas and Condemi, PA
Englewood, New Jersey, 07631, United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Newark Beth Israel Hospital
Newark, New Jersey, 07112, United States
Somerset Hematology Oncology Associates
Somerville, New Jersey, 08876, United States
Sparta Cancer Center
Sparta, New Jersey, 07871, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
Stratton VA Medical Center IRB
Albany, New York, 12208, United States
Buffalo Institute for Medical Research, Inc.
Buffalo, New York, 14215, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
Goshen Medical Associates
Goshen, New York, 10924, United States
Huntington Medical Group
Huntington Station, New York, 11746, United States
North Shore-Long Island Jewish Health System
Lake Success, New York, 11042, United States
Arena Oncology Associates
New Hyde Park, New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian Hospital-Cornell Campus
New York, New York, 10021, United States
Interlakes Foundation, Inc.
Rochester, New York, 14623, United States
Richmond University Medical Center
Staten Island, New York, 10301, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Eastchester Center for Cancer Care
The Bronx, New York, 10469, United States
New York Medical College
Valhalla, New York, 10595, United States
Cancer Care of WNC
Asheville, North Carolina, 28801, United States
Alamance Regional Medical Center
Burlington, North Carolina, 27215, United States
Blood and Cancer Clinic
Fayetteville, North Carolina, 28304, United States
Gaston Hematology & Oncology
Gastonia, North Carolina, 28054, United States
Carolina Oncology Specialist, PA
Hickory, North Carolina, 28603, United States
Emerywood Hematology/Oncology
High Point, North Carolina, 27262, United States
Raleigh Hematology Oncology / Associates, P.C.
Raleigh, North Carolina, 27607, United States
Hanover Medical Specialists, P.A.
Wilmington, North Carolina, 28401, United States
St. Alexius Clinical Research Services
Bismarck, North Dakota, 58501, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45215, United States
Oncology Partners Network
Cincinnati, Ohio, 45247, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Hematology Oncology Consultants Inc.
Columbus, Ohio, 43235, United States
Dayton Clinical Oncology Program
Dayton, Ohio, 45429, United States
Dayton Oncology & Hematology
Kettering, Ohio, 45409, United States
Toledo Community Hospital Oncology Program
Toledo, Ohio, 43617, United States
Trilogy Cancer Center
Wooster, Ohio, 44691, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Oncology and Hematology
Tulsa, Oklahoma, 74136, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Onc-Hem of Lehigh Valley, PC
Bethlehem, Pennsylvania, 18015, United States
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512, United States
Medical Oncology Associates
Kingston, Pennsylvania, 18704, United States
Regional Hematology Oncology Associates
Langhorne, Pennsylvania, 19047, United States
Greater Philadelphia Cancer and Hematology Specialists, PC
Philadelphia, Pennsylvania, 19114, United States
UPMC Cancer Pavillioin
Pittsburgh, Pennsylvania, 15232, United States
Guthrie Research Institute
Sayre, Pennsylvania, 18840, United States
Scranton Hematology Oncology
Scranton, Pennsylvania, 18510, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29605, United States
Low Country Hematology & Oncology
Mt. Pleasant, South Carolina, 29464, United States
Santee Hematology/Oncology
Sumter, South Carolina, 29150, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
The Family Cancer Center, PLLC
Collierville, Tennessee, 38017, United States
The Cancer Center of Cookeville Regional Medical Center
Cookeville, Tennessee, 38501, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
East Tennessee Oncology/Hematology
Knoxville, Tennessee, 37920, United States
University of Tennesee Medical Center
Knoxville, Tennessee, 37920, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Cancer Center
Abilene, Texas, 79606-5208, United States
Texas Oncology, P.A.
Arlington, Texas, 76014, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
Texas Oncology, PA
Austin, Texas, 78731, United States
Texas Oncology, PA
Beaumont, Texas, 77702, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, 73112, United States
South Texas Institute of Cancer and Blood Disorders
Corpus Christi, Texas, 78405, United States
Texas Oncology
Dallas, Texas, 75230-2510, United States
Dallas Oncology Consultants
Dallas, Texas, 75237, United States
Texas Oncology, PA / Methodist Charlton Cancer Center
Dallas, Texas, 75237, United States
Texas Oncology PA
Dallas, Texas, 75246, United States
Texas Cancer Center
Denton, Texas, 76210, United States
El Paso Cancer Treatment Center
El Paso, Texas, 79902, United States
Texas Cancer Center
Fort Worth, Texas, 76104, United States
Texas Oncology, PA
Garland, Texas, 75042, United States
Lee C. Drinkard, MD
Grapevine, Texas, 76051, United States
Houston Cancer Institute
Houston, Texas, 77055, United States
Medicus Alliance Clinical Research Organization, LLC
Houston, Texas, 77090, United States
Lake Vista Cancer Center
Lewisville, Texas, 75067, United States
Longview Cancer Center
Longview, Texas, 75601, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Texas Oncology, P.A.
Midland, Texas, 79701, United States
Texas Oncology - Odessa
Odessa, Texas, 79761, United States
Paris Regional Cancer Center
Paris, Texas, 75460, United States
Cancer Care Network of South Texas
San Antonio, Texas, 78217, United States
Cancer Care Center of South Texas
San Antonio, Texas, 78229, United States
CTRC Institute for Drug Development
San Antonio, Texas, 78245, United States
Texas Cancer Center - Sherman
Sherman, Texas, 75090, United States
Blood and Cancer Center of East Texas
Tyler, Texas, 75701, United States
Tyler Hematology/Oncology, PA
Tyler, Texas, 75701, United States
Texas Oncology, PA
Tyler, Texas, 75702, United States
Texas Oncology
Waco, Texas, 76712, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
The University of Vermont
Burlington, Vermont, 05401, United States
White River Junction VAMC
White River Junction, Vermont, 05009-001, United States
Cancer Specialists of Tidewater
Chesapeake, Virginia, 23320, United States
Fairfax/Northern Virginia Hematology/Oncology
Fairfax, Virginia, 22031, United States
Lynchburg Hematology Oncology Clinic, Inc.
Lynchburg, Virginia, 24501, United States
Peninsula Cancer Institute Riverside Cancer Center
Newport News, Virginia, 23601, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Masoom Kandahari, MD, PC
Woodbridge, Virginia, 22191, United States
Puget Sound Cancer Center - Edmonds
Edmonds, Washington, 98026, United States
Providence Everett Medical Center
Everett, Washington, 98201, United States
Puget Sound Cancer Center, Inc
Seattle, Washington, 98133, United States
Cancer Care Northwest, US Oncology
Spokane, Washington, 99202, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Yakima Valley Memorial Hospital / North Star Lodge
Yakima, Washington, 98902, United States
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, 54601, United States
Alyce & Elmore Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center
San Juan, 00919-1227, Puerto Rico
Related Publications (1)
Niesvizky R, Flinn IW, Rifkin R, Gabrail N, Charu V, Clowney B, Essell J, Gaffar Y, Warr T, Neuwirth R, Zhu Y, Elliott J, Esseltine DL, Niculescu L, Reeves J. Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens. J Clin Oncol. 2015 Nov 20;33(33):3921-9. doi: 10.1200/JCO.2014.58.7618. Epub 2015 Jun 8.
PMID: 26056177DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Millennium Pharmaceuticals Inc
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2007
First Posted
July 26, 2007
Study Start
June 1, 2007
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 1, 2014
Results First Posted
May 1, 2014
Record last verified: 2014-03