Clinical trial NCT00507416: Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-26
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization until disease progression. Median follow-up time was 43 months.
Secondary outcomes:
measure: Percentage of Participants With an Overall Response
timeFrame: Response assessed every other cycle for up to 13 cycles (49 weeks).
measure: Percentage of Participants With a Complete Response
timeFrame: Response assessed every other cycle, for up to 13 cycles (49 weeks).
measure: Percentage of Participants With a Complete Response or a Very Good Partial Response
timeFrame: Response assessed every other cycle for up to 13 cycles (49 weeks).
measure: Duration of Response
timeFrame: From first documented response until disease progression. Median follow-up time was 43 months.
measure: Overall Survival
timeFrame: From randomization until death. Median follow-up time was 43 months.
measure: Time to Alternative Therapy
timeFrame: From randomization until alternative therapy. Median follow-up time was 43 months.
measure: Change From Baseline in EORTC QLQ-C30 - Global Health Status
timeFrame: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology Oncology Assciates, LLC
state: Alabama
city: Casa Grande
country: United States
facility: Desert Oasis Cancer Center
state: Arizona
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates - AOA
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Hot Springs
country: United States
facility: Heritage Physician Group Oncology
state: Arkansas
city: Little Rock
country: United States
facility: Hematology Oncology Services of Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Centre
state: California
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: Robert A. Moss, MD, FACP, Inc.
state: California
city: Fresno
country: United States
facility: Cancer Care Associates
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital & Health Center
state: California
city: Greenbrae
country: United States
facility: California Cancer Care
state: California
city: Highland
country: United States
facility: Beaver Medical Group
state: California
city: Laguna Beach
country: United States
facility: Edward A. Wagner, MD
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Poway
country: United States
facility: Southwest Cancer Care
state: California
city: Rancho Mirage
country: United States
facility: Desert Cancer Care, Incorporated
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: Soquel
country: United States
facility: Cancer Research & Prevention Center
state: California
city: Stockton
country: United States
facility: Stockton Hematology/Oncology
state: California
city: Westlake Village
country: United States
facility: Trivalley Oncology Hematology
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Boca Raton
country: United States
facility: The Center for Hematology-Oncology
state: Florida
city: Brooksville
country: United States
facility: Pasco Hernando Oncology
state: Florida
city: Coral Springs
country: United States
facility: Northwest Oncology & Hematology Associates
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Hollywood
country: United States
facility: Horizon Institute for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Jacksonville
country: United States
facility: University of Florida- Jacksonville
state: Florida
city: Lake City
country: United States
facility: Cancer Care of North Florida
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Lecanto
country: United States
facility: Cancer & Blood Disease Center
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: North Miami Beach
country: United States
facility: Innovative Medical Research of South Florida Inc.
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast, PA
state: Florida
city: St. Petersburg
country: United States
facility: Gulfcoast Oncology Associates
state: Florida
city: West Palm Beach
country: United States
facility: S. Florida Oncology/ Hematology
state: Florida
city: Augusta
country: United States
facility: Medical Oncology Associates of Augusta
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Boise
country: United States
facility: St. Lukes Mountain States Tumor Institute
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Oncology of Eastern Idaho, PLLC.
state: Idaho
city: Arlington Heights
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Elmhurst
country: United States
facility: Elmhurst Memorial Hospital
state: Illinois
city: Gurnee
country: United States
facility: Oncology Hematology Associates of North Illinois Ltd.
state: Illinois
city: Joliet
country: United States
facility: Midwest Center for Hematology / Oncology
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd.
state: Illinois
city: Naperville
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Illinois
city: Niles
country: United States
facility: Cancer Care and Hematology Specialists of Chicagoland
state: Illinois
city: Normal
country: United States
facility: Mid-Illinois Hem & Onc
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Incorporated
state: Indiana
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Lafayette
country: United States
facility: Clarian Arnett Cancer Center
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, PC
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, P.C.
state: Iowa
city: Council Bluffs
country: United States
facility: Heartland Hematology-Oncology Associates, Inc.
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology/Oncology Assoc., LLP
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Cancer Centers - Southwest
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Danville
country: United States
facility: Commonwealth Cancer Center
state: Kentucky
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Paducah
country: United States
facility: Western Kentucky Hematology and Oncology Group
state: Kentucky
city: Alexandria
country: United States
facility: Christus St. Francis Cabrini Cancer Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Hematology-Oncology Clinic
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Oncology Center
state: Maryland
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Health Care
state: Maryland
city: Baltimore
country: United States
facility: Auerbach Hematology Oncology Associates
state: Maryland
city: Baltimore
country: United States
facility: Maryland Hematology Oncology Association
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Clinton
country: United States
facility: Oncology-Hematology Associates, P.A.
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Westminster
country: United States
facility: Carroll County Cancer Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic at Worcester Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology and Oncology
state: Michigan
city: Lambertville
country: United States
facility: Hematology Oncology Associates of Ohio & Michigan, PC
state: Michigan
city: Lansing
country: United States
facility: Breslin Cancer Center / Great Lakes Cancer Institute
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Center
state: Michigan
city: St. Joseph
country: United States
facility: Oncology Care Associates, P.L.L.C.
state: Michigan
city: Woodhaven
country: United States
facility: Osteopathic Medical Hematology & Oncology
state: Michigan
city: Duluth
country: United States
facility: St. Luke's Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Metro MN CCOP
state: Minnesota
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center
state: Minnesota
city: Chesterfield
country: United States
facility: St. Louis Cancer Center
state: Missouri
city: Jefferson City
country: United States
facility: Capital Region Medical Center/Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: Heartland Hematology-Oncology Associates, Inc.
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Veterans Administration Medical Center
state: Missouri
city: St. Joseph
country: United States
facility: St. Joseph Oncology
state: Missouri
city: Great Falls
country: United States
facility: Great Falls Clinic, LLP
state: Montana
city: North Platte
country: United States
facility: Great Plains Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Creighton Cancer Center
state: Nebraska
city: Henderson
country: United States
facility: Las Vegas Cancer Center
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: East Orange
country: United States
facility: Veterans Affairs New Jersey Healthcare System
state: New Jersey
city: Englewood
country: United States
facility: Drs. Forte, Schleider, Attas and Condemi, PA
state: New Jersey
city: Livingston
country: United States
facility: St. Barnabas Medical Center
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Hospital
state: New Jersey
city: Somerville
country: United States
facility: Somerset Hematology Oncology Associates
state: New Jersey
city: Sparta
country: United States
facility: Sparta Cancer Center
state: New Jersey
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Albany
country: United States
facility: Stratton VA Medical Center IRB
state: New York
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Buffalo
country: United States
facility: Buffalo Institute for Medical Research, Inc.
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Goshen
country: United States
facility: Goshen Medical Associates
state: New York
city: Huntington Station
country: United States
facility: Huntington Medical Group
state: New York
city: Lake Success
country: United States
facility: North Shore-Long Island Jewish Health System
state: New York
city: New Hyde Park
country: United States
facility: Arena Oncology Associates
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Cornell Campus
state: New York
city: Rochester
country: United States
facility: Interlakes Foundation, Inc.
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Asheville
country: United States
facility: Cancer Care of WNC
state: North Carolina
city: Burlington
country: United States
facility: Alamance Regional Medical Center
state: North Carolina
city: Fayetteville
country: United States
facility: Blood and Cancer Clinic
state: North Carolina
city: Gastonia
country: United States
facility: Gaston Hematology & Oncology
state: North Carolina
city: Hickory
country: United States
facility: Carolina Oncology Specialist, PA
state: North Carolina
city: High Point
country: United States
facility: Emerywood Hematology/Oncology
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology / Associates, P.C.
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists, P.A.
state: North Carolina
city: Bismark
country: United States
facility: St. Alexius Clinical Research Services
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Partners Network
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants Inc.
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Oncology Program
state: Ohio
city: Kettering
country: United States
facility: Dayton Oncology & Hematology
state: Ohio
city: Toledo
country: United States
facility: Toledo Community Hospital Oncology Program
state: Ohio
city: Wooster
country: United States
facility: Trilogy Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Oncology and Hematology
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Bethlehem
country: United States
facility: Onc-Hem of Lehigh Valley, PC
state: Pennsylvania
city: Dunmore
country: United States
facility: Hematology & Oncology Associates of NEPA
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Langhorne
country: United States
facility: Regional Hematology Oncology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Greater Philadelphia Cancer and Hematology Specialists, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Pavillioin
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Research Institute
state: Pennsylvania
city: Scranton
country: United States
facility: Scranton Hematology Oncology
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center
state: South Carolina
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Low Country Hematology & Oncology
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology/Oncology
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Collierville
country: United States
facility: The Family Cancer Center, PLLC
state: Tennessee
city: Cookeville
country: United States
facility: The Cancer Center of Cookeville Regional Medical Center
state: Tennessee
city: Germantown
country: United States
facility: The Jones Clinic
state: Tennessee
city: Knoxville
country: United States
facility: East Tennessee Oncology/Hematology
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennesee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Abilene
country: United States
facility: Texas Cancer Center
state: Texas
city: Arlington
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Austin
country: United States
facility: Texas Oncology, PA
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology, PA
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Institute of Cancer and Blood Disorders
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: Dallas Oncology Consultants
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA / Methodist Charlton Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology PA
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Cancer Center
state: Texas
city: Garland
country: United States
facility: Texas Oncology, PA
state: Texas
city: Grapevine
country: United States
facility: Lee C. Drinkard, MD
state: Texas
city: Houston
country: United States
facility: Houston Cancer Institute
state: Texas
city: Houston
country: United States
facility: Medicus Alliance Clinical Research Organization, LLC
state: Texas
city: Lewisville
country: United States
facility: Lake Vista Cancer Center
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center of Mesquite
state: Texas
city: Midland
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Odessa
country: United States
facility: Texas Oncology - Odessa
state: Texas
city: Paris
country: United States
facility: Paris Regional Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Network of South Texas
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Center of South Texas
state: Texas
city: San Antonio
country: United States
facility: CTRC Institute for Drug Development
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center - Sherman
state: Texas
city: Tyler
country: United States
facility: Blood and Cancer Center of East Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology/Oncology, PA
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, PA
state: Texas
city: Waco
country: United States
facility: Texas Oncology
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Burlington
country: United States
facility: The University of Vermont
state: Vermont
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
city: Chesapeake
country: United States
facility: Cancer Specialists of Tidewater
state: Virginia
city: Fairfax
country: United States
facility: Fairfax/Northern Virginia Hematology/Oncology
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Hematology Oncology Clinic, Inc.
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute Riverside Cancer Center
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Salem
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Woodbridge
country: United States
facility: Masoom Kandahari, MD, PC
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Center - Edmonds
state: Washington
city: Everett
country: United States
facility: Providence Everett Medical Center
state: Washington
city: Seattle
country: United States
facility: Puget Sound Cancer Center, Inc
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest, US Oncology
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital / North Star Lodge
state: Washington
city: La Crosse
country: United States
facility: Gundersen Clinic, Ltd.
state: Wisconsin
city: West Bend
country: United States
facility: Alyce & Elmore Kraemer Cancer Center
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.