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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bortezomib
Dexamethasone
Melphalan
Prednisone
Thalidomide
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.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.

Sites / Locations

  • Birmingham Hematology Oncology Assciates, LLC
  • Desert Oasis Cancer Center
  • Northern Arizona Hematology & Oncology Associates - AOA
  • Arizona Oncology Associates
  • Heritage Physician Group Oncology
  • Hematology Oncology Services of Arkansas
  • Pacific Cancer Medical Centre
  • Tower Cancer Research Foundation
  • Compassionate Cancer Care Medical Group
  • Compassionate Cancer Care Medical Group, Inc.
  • Robert A. Moss, MD, FACP, Inc.
  • Cancer Care Associates
  • Glendale Memorial Hospital & Health Center
  • California Cancer Care
  • Beaver Medical Group
  • Edward A. Wagner, MD
  • Clinical Trials and Research Associates, Inc.
  • Medical Oncology Care Associates
  • Ventura County Hematology Oncology Specialists
  • Southwest Cancer Care
  • Desert Cancer Care, Incorporated
  • Compassionate Cancer Care Medical Group, Inc.
  • Sutter Cancer Center
  • Cancer Research & Prevention Center
  • Stockton Hematology/Oncology
  • Trivalley Oncology Hematology
  • Rocky Mountain Cancer Center
  • Cancer Center of Central Connecticut
  • Christiana Care Health Services
  • The Center for Hematology-Oncology
  • Pasco Hernando Oncology
  • Northwest Oncology & Hematology Associates
  • Florida Cancer Specialists
  • Horizon Institute for Clinical Research
  • Baptist Cancer Institute
  • University of Florida- Jacksonville
  • Cancer Care of North Florida
  • Lakeland Regional Cancer Center
  • Cancer & Blood Disease Center
  • Pasco Hernando Oncology
  • Florida Cancer Institute
  • Innovative Medical Research of South Florida Inc.
  • Ocala Oncology Center
  • Cancer Centers of Florida, P.A.
  • MD Anderson Cancer Center Orlando
  • Hematology Oncology Associates of the Treasure Coast, PA
  • Gulfcoast Oncology Associates
  • S. Florida Oncology/ Hematology
  • Medical Oncology Associates of Augusta
  • Central Georgia Cancer Care
  • Northwest Georgia Oncology Centers, P.C.
  • Summit Cancer Care
  • St. Lukes Mountain States Tumor Institute
  • Snake River Oncology of Eastern Idaho, PLLC.
  • Cancer Care & Hematology Specialists of Chicagoland
  • Hematology Oncology Associates of Illinois
  • John H. Stroger, Jr. Hospital of Cook County
  • University of Chicago
  • Hematology Oncology Associates of Illinois
  • Elmhurst Memorial Hospital
  • Oncology Hematology Associates of North Illinois Ltd.
  • Midwest Center for Hematology / Oncology
  • Joliet Oncology-Hematology Associates, Ltd.
  • Hematology Oncology Consultants, Inc.
  • Cancer Care and Hematology Specialists of Chicagoland
  • Mid-Illinois Hem & Onc
  • Quincy Medical Group
  • Deaconess Clinic Incorporated
  • Central Indiana Cancer Centers
  • Investigative Clinical Research of Indiana, LLC
  • Clarian Arnett Cancer Center
  • Medical Consultants, PC
  • Cancer Care Center
  • Memorial Hospital of South Bend
  • Hope Center
  • McFarland Clinic, P.C.
  • Heartland Hematology-Oncology Associates, Inc.
  • Siouxland Hematology/Oncology Assoc., LLP
  • Kansas City Cancer Centers - Southwest
  • Cancer Center of Kansas
  • Commonwealth Cancer Center
  • Kentucky Cancer Clinic
  • Western Kentucky Hematology and Oncology Group
  • Christus St. Francis Cabrini Cancer Center
  • Hematology-Oncology Clinic
  • Annapolis Oncology Center
  • Greater Baltimore Medical Center
  • St. Agnes Health Care
  • Auerbach Hematology Oncology Associates
  • Maryland Hematology Oncology Association
  • Center for Cancer and Blood Disorders
  • Oncology-Hematology Associates, P.A.
  • Maryland Oncology Hematology, PA
  • Carroll County Cancer Center
  • Boston Medical Center
  • Fallon Clinic at Worcester Medical Center
  • Henry Ford Health System
  • Cancer & Hematology Centers of Western Michigan
  • Kalamazoo Hematology and Oncology
  • Hematology Oncology Associates of Ohio & Michigan, PC
  • Breslin Cancer Center / Great Lakes Cancer Institute
  • Providence Cancer Center
  • Oncology Care Associates, P.L.L.C.
  • Osteopathic Medical Hematology & Oncology
  • St. Luke's Hospital
  • Metro MN CCOP
  • Hubert H. Humphrey Cancer Center
  • St. Louis Cancer Center
  • Capital Region Medical Center/Cancer Center
  • Heartland Hematology-Oncology Associates, Inc.
  • Kansas City Veterans Administration Medical Center
  • St. Joseph Oncology
  • Great Falls Clinic, LLP
  • Great Plains Regional Medical Center
  • Creighton Cancer Center
  • Las Vegas Cancer Center
  • Comprehensive Cancer Centers of Nevada
  • Veterans Affairs New Jersey Healthcare System
  • Drs. Forte, Schleider, Attas and Condemi, PA
  • St. Barnabas Medical Center
  • Newark Beth Israel Hospital
  • Somerset Hematology Oncology Associates
  • Sparta Cancer Center
  • New Mexico Cancer Care Associates
  • Stratton VA Medical Center IRB
  • Eastchester Center for Cancer Care
  • Buffalo Institute for Medical Research, Inc.
  • Erie County Medical Center
  • Goshen Medical Associates
  • Huntington Medical Group
  • North Shore-Long Island Jewish Health System
  • Arena Oncology Associates
  • Memorial Sloan Kettering Cancer Center
  • New York Presbyterian Hospital-Cornell Campus
  • Interlakes Foundation, Inc.
  • Richmond University Medical Center
  • SUNY Upstate Medical University
  • New York Medical College
  • Cancer Care of WNC
  • Alamance Regional Medical Center
  • Blood and Cancer Clinic
  • Gaston Hematology & Oncology
  • Carolina Oncology Specialist, PA
  • Emerywood Hematology/Oncology
  • Raleigh Hematology Oncology / Associates, P.C.
  • Hanover Medical Specialists, P.A.
  • St. Alexius Clinical Research Services
  • Gabrail Cancer Center
  • Oncology Hematology Care, Inc.
  • Oncology Partners Network
  • University Hospitals of Cleveland
  • Hematology Oncology Consultants Inc.
  • Dayton Clinical Oncology Program
  • Dayton Oncology & Hematology
  • Toledo Community Hospital Oncology Program
  • Trilogy Cancer Center
  • Cancer Care Associates
  • Oklahoma Oncology and Hematology
  • Willamette Valley Cancer Center
  • Onc-Hem of Lehigh Valley, PC
  • Hematology & Oncology Associates of NEPA
  • Medical Oncology Associates
  • Regional Hematology Oncology Associates
  • Greater Philadelphia Cancer and Hematology Specialists, PC
  • UPMC Cancer Pavillioin
  • Guthrie Research Institute
  • Scranton Hematology Oncology
  • Roger Williams Medical Center
  • MUSC Hollings Cancer Center
  • Cancer Center of the Carolinas
  • Low Country Hematology & Oncology
  • Santee Hematology/Oncology
  • Avera Research Institute
  • Chattanooga Oncology Hematology Associates
  • The Family Cancer Center, PLLC
  • The Cancer Center of Cookeville Regional Medical Center
  • The Jones Clinic
  • East Tennessee Oncology/Hematology
  • University of Tennesee Medical Center
  • Sarah Cannon Research Institute
  • Texas Cancer Center
  • Texas Oncology, P.A.
  • Southwest Regional Cancer Center
  • Texas Oncology, PA
  • Texas Oncology, PA
  • Texas Oncology, P.A.
  • Coastal Bend Cancer Center
  • South Texas Institute of Cancer and Blood Disorders
  • Texas Oncology
  • Dallas Oncology Consultants
  • Texas Oncology, PA / Methodist Charlton Cancer Center
  • Texas Oncology PA
  • Texas Cancer Center
  • El Paso Cancer Treatment Center
  • Texas Cancer Center
  • Texas Oncology, PA
  • Lee C. Drinkard, MD
  • Houston Cancer Institute
  • Medicus Alliance Clinical Research Organization, LLC
  • Lake Vista Cancer Center
  • Longview Cancer Center
  • Texas Cancer Center of Mesquite
  • Texas Oncology, P.A.
  • Texas Oncology - Odessa
  • Paris Regional Cancer Center
  • Cancer Care Network of South Texas
  • Cancer Care Center of South Texas
  • CTRC Institute for Drug Development
  • Texas Cancer Center - Sherman
  • Blood and Cancer Center of East Texas
  • Tyler Hematology/Oncology, PA
  • Texas Oncology, PA
  • Texas Oncology
  • Northern Utah Associates
  • Utah Cancer Specialists
  • The University of Vermont
  • White River Junction VAMC
  • Cancer Specialists of Tidewater
  • Fairfax/Northern Virginia Hematology/Oncology
  • Lynchburg Hematology Oncology Clinic, Inc.
  • Peninsula Cancer Institute Riverside Cancer Center
  • Virginia Oncology Associates
  • Virginia Cancer Institute
  • Oncology and Hematology Associates of Southwest Virginia, Inc.
  • Masoom Kandahari, MD, PC
  • Puget Sound Cancer Center - Edmonds
  • Providence Everett Medical Center
  • Puget Sound Cancer Center, Inc
  • Cancer Care Northwest, US Oncology
  • Northwest Medical Specialties, PLLC
  • Wenatchee Valley Medical Center
  • Yakima Valley Memorial Hospital / North Star Lodge
  • Gundersen Clinic, Ltd.
  • Alyce & Elmore Kraemer Cancer Center
  • Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Bortezomib and Dexamethasone (VD)

Bortezomib, Thalidomide, and Dexamethasone (VTD)

Bortezomib, Melphalan and Prednisone (VMP)

Arm Description

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).

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) .

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants With an Overall Response
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
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
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
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
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 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
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.

Full Information

First Posted
July 25, 2007
Last Updated
March 28, 2014
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00507416
Brief Title
Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone
Acronym
UPFRONT
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bortezomib and Dexamethasone (VD)
Arm Type
Experimental
Arm Description
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).
Arm Title
Bortezomib, Thalidomide, and Dexamethasone (VTD)
Arm Type
Experimental
Arm Description
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) .
Arm Title
Bortezomib, Melphalan and Prednisone (VMP)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
Bortezomib bolus intravenous (IV) injection
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone for oral administration
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Melphalan for oral administration
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone for oral administration
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Thalidomide for oral administration
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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
Time Frame
From randomization until disease progression. Median follow-up time was 43 months.
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Overall Response
Description
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.
Time Frame
Response assessed every other cycle for up to 13 cycles (49 weeks).
Title
Percentage of Participants With a Complete Response
Description
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.
Time Frame
Response assessed every other cycle, for up to 13 cycles (49 weeks).
Title
Percentage of Participants With a Complete Response or a Very Good Partial Response
Description
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.
Time Frame
Response assessed every other cycle for up to 13 cycles (49 weeks).
Title
Duration of Response
Description
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.
Time Frame
From first documented response until disease progression. Median follow-up time was 43 months.
Title
Overall Survival
Description
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 Frame
From randomization until death. Median follow-up time was 43 months.
Title
Time to Alternative Therapy
Description
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.
Time Frame
From randomization until alternative therapy. Median follow-up time was 43 months.
Title
Change From Baseline in EORTC QLQ-C30 - Global Health Status
Description
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.
Time Frame
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
26056177
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.
Results Reference
derived

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Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone

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