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Randomized Phase 3b Study in Previously Untreated Multiple Myeloma Patients: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone (UPFRONT)
This study is currently recruiting participants.
Verified by Millennium Pharmaceuticals, Inc., December 2009
First Received: July 25, 2007   Last Updated: December 2, 2009   History of Changes
Sponsor: Millennium Pharmaceuticals, Inc.
Information provided by: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00507416
  Purpose

This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of VELCADE dexamethasone versus VELCADE, thalidomide, and dexamethasone versus VELCADE, melphalan, and prednisone in patients with previously untreated multiple myeloma who are not considered candidates for high-dose chemotherapy and autologous stem cell transplantation. This study will consist of a Screening period (generally 4 weeks or less), an Induction Treatment period (approximately 6 months), a Maintenance Treatment period (approximately 6 months), and a Post-treatment period.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib, thalidomide, and dexamethasone (VTD)
Drug: bortezomib and dexamethasone (VD)
Drug: bortezomib, melphalan and prednisone (VMP)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression Free Survival. [ Time Frame: Up to 3 years after treatment is completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Overall response rate - Overall survival - Time to alternative therapy [ Time Frame: Up to 3 years after treatment is completed ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: June 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bortezomib, Thalidomide, and Dexamethasone (VTD): Experimental Drug: bortezomib, thalidomide, and dexamethasone (VTD)

bortezomib intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8.

Thalidomide orally on Days 1-21 of a 21-day cycle during Cycles 1-8.

Dexamethasone orally once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after bortezomib administration), and then orally QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8

Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13.

Bortezomib and Dexamethasone (VD): Experimental Drug: bortezomib and dexamethasone (VD)

bortezomib intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8.

Dexamethasone orally once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after bortezomib administration), and then orally QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8.

Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13.

Bortezomib, melphalan, and prednisone (VMP): Experimental Drug: bortezomib, melphalan and prednisone (VMP)

bortezomib administered intravenously on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8.

Melphalan: orally once daily (QD) on Days 1-4 every other cycle during Cycles 1-8.

Prednisone:orally QD on Days 1-4 every other cycle during Cycles 1-8.

Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive bortezomib intravenously on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13.


  Eligibility

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

Inclusion Criteria:

  • Male or female subjects 18 years of age or older
  • Subject is 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).
  • Subject 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 IgG 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 subject at any time without prejudice to future medical care.

Exclusion Criteria:

  • Diagnosis of smoldering multiple myeloma or 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 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 subjects 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/mm3
  • Platelets <100,000 × 109/L, or <70 × 109/L if thrombocytopenia is considered by the investigator to be due to myeloma infiltration of bone marrow
  • Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2× the ULN
  • Serum creatinine >2 mg/dL (>176.8µmol/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 subject 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 subject has been disease-free for at least 3 years.
  • Female subject who is pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test with a sensitivity of at least 50 mIU/mL during Screening.
  • Use of any investigational drugs within 30 days before randomization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507416

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-866-835-2233 medical@mlnm.com

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology Oncology Assciates, LLC Recruiting
Birmingham, Alabama, United States, 35205
Southern Cancer Center Withdrawn
Mobile, Alabama, United States, 36608
United States, Arizona
Desert Oasis Cancer Center Recruiting
Casa Grande, Arizona, United States, 85222
Northern Arizona Hematology & Oncology Associates - AOA Recruiting
Sedona, Arizona, United States, 86336
Arizona Oncology Associates Recruiting
Tucson, Arizona, United States, 85704
United States, Arkansas
Heritage Physician Group Oncology Recruiting
Hot Springs, Arkansas, United States, 71913
Hematology Oncology Services of Arkansas Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Pacific Cancer Medical Centre Recruiting
Anaheim, California, United States, 92801
Beaver Medical Group Recruiting
Highland, California, United States, 92346
Compassionate Cancer Care Medical Group Recruiting
Corona, California, United States, 92882
Compassionate Cancer Care Medical Group, Inc. Recruiting
Fountain Valley, California, United States, 92708
Robert A. Moss, MD, FACP, Inc. Recruiting
Fountain Valley, California, United States, 92708
Cancer Care Associates Recruiting
Fresno, California, United States, 93720
Glendale Memorial Hospital & Health Center Recruiting
Glendale, California, United States, 91204
California Cancer Care Recruiting
Greenbrae, California, United States, 94904
Tower Cancer Research Foundation Recruiting
Beverly Hills, California, United States, 90211-1850
Contact: Peter Rosen            
Scripps Cancer Center Withdrawn
La Jolla, California, United States, 92037
Wilshire Oncology Medical Group Withdrawn
La Verne, California, United States, 91750
Edward A. Wagner, MD Recruiting
Laguna Beach, California, United States, 92882
Clinical Trials and Research Associates, Inc. Recruiting
Montebello, California, United States, 90640
Medical Oncology Care Associates Recruiting
Orange, California, United States, 92868
Compassionate Cancer Care Medical Group, Inc. Recruiting
Riverside, California, United States, 92501
Southwest Cancer Care Recruiting
Poway, California, United States, 92064
Desert Cancer Care, Incorporated Recruiting
Rancho Mirage, California, United States, 92270
Ventura County Hematology Oncology Specialists Recruiting
Oxnard, California, United States, 93030
Sutter Cancer Center Recruiting
Sacramento, California, United States, 95816
Contact: Michael Carroll            
Cancer Research & Prevention Center Recruiting
Soquel, California, United States, 95073
Stockton Hematology/Oncology Recruiting
Stockton, California, United States, 95204
Trivalley Oncology Hematology Recruiting
Westlake Village, California, United States, 91361
Contact: Ashwin Kashyap, MD            
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Denver, Colorado, United States, 80218
Front Range Cancer Specialists Withdrawn
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Cancer Center of Central Connecticut Recruiting
Southington, Connecticut, United States, 06489
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19718
United States, Florida
The Center for Hematology-Oncology Recruiting
Boca Raton, Florida, United States, 33486
Pasco Hernando Oncology Recruiting
Brooksville, Florida, United States, 34613
Northwest Oncology & Hematology Associates Recruiting
Coral Springs, Florida, United States, 33065
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33901
Contact: James Reeves, MD            
Horizon Institute for Clinical Research Recruiting
Hollywood, Florida, United States, 33021
University of Florida- Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Fauzia Rana            
Baptist Cancer Institute Recruiting
Jacksonville, Florida, United States, 32207
Cancer Care of North Florida Recruiting
Lake City, Florida, United States, 32024
Lakeland Regional Cancer Center Recruiting
Lakeland, Florida, United States, 33805
MD Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Advanced Medical Specialties Withdrawn
Miami, Florida, United States, 33176
Pasco Hernando Oncology Recruiting
New Port Richey, Florida, United States, 34652
Florida Cancer Institute Recruiting
New Port Richey, Florida, United States, 34655
Innovative Medical Research of South Florida Inc. Recruiting
North Miami Beach, Florida, United States, 33179
Ocala Oncology Center Recruiting
Ocala, Florida, United States, 34474
Cancer Centers of Florida, P.A. Recruiting
Ocoee, Florida, United States, 34761
Cancer & Blood Disease Center Recruiting
Lecanto, Florida, United States, 34461
Hematology Oncology Associates of the Treasure Coast, PA Recruiting
Port St. Lucie, Florida, United States, 34952
Gulfcoast Oncology Associates Recruiting
St. Petersburg, Florida, United States, 33705
Stuart Oncology Withdrawn
Stuart, Florida, United States, 34994
S. Florida Oncology/ Hematology Recruiting
West Palm Beach, Florida, United States, 33458
Contact: Lawrence Tepper            
United States, Georgia
Medical Oncology Associates of Augusta Recruiting
Augusta, Georgia, United States, 30901
Piedmont Hospital Withdrawn
Atlanta, Georgia, United States, 30309
Augusta Oncology Withdrawn
Augusta, Georgia, United States, 30901
Northeast Georgia Cancer Care, LLC Withdrawn
Athens, Georgia, United States, 30607
Suburban Hematology/Oncology Associates Withdrawn
Lawrenceville, Georgia, United States, 30045
Central Georgia Cancer Care Recruiting
Macon, Georgia, United States, 31201
Northwest Georgia Oncology Centers, P.C. Recruiting
Marietta, Georgia, United States, 30060
Summit Cancer Care Recruiting
Savannah, Georgia, United States, 31405
United States, Idaho
St. Lukes Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Theodore Walters            
Snake River Oncology of Eastern Idaho, PLLC. Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Cancer Care & Hematology Specialists of Chicagoland Recruiting
Arlington Heights, Illinois, United States, 60005
Hematology Oncology Associates of Illinois Recruiting
Chicago, Illinois, United States, 60657
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
John H. Stroger, Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Hematology Oncology Associates of Illinois Recruiting
Chicago, Illinois, United States, 60611
Elmhurst Memorial Hospital Recruiting
Elmhurst, Illinois, United States, 60126
Oncology Hematology Associates of North Illinois Ltd. Recruiting
Gurnee, Illinois, United States, 60031-3399
Contact: Nilesh Mehta            
Cancer Care and Hematology Specialists of Chicagoland Recruiting
Niles, Illinois, United States, 60714
Joliet Oncology-Hematology Associates, Ltd. Recruiting
Joliet, Illinois, United States, 60435
Hematology Oncology Consultants, Inc. Recruiting
Naperville, Illinois, United States, 60540
Midwest Center for Hematology / Oncology Recruiting
Joliet, Illinois, United States, 60432
Mid-Illinois Hem & Onc Recruiting
Normal, Illinois, United States, 61761
Quincy Medical Group Recruiting
Quincy, Illinois, United States, 62301
United States, Indiana
Deaconess Clinic Incorporated Recruiting
Evansville, Indiana, United States, 47713
Investigative Clinical Research of Indiana, LLC Recruiting
Indianapolis, Indiana, United States, 46254
Cancer Care Center Recruiting
New Albany, Indiana, United States, 47150
Clarian Arnett Cancer Center Recruiting
Lafayette, Indiana, United States, 47904
Medical Consultants, PC Recruiting
Muncie, Indiana, United States, 47303
Central Indiana Cancer Centers Recruiting
Indianapolis, Indiana, United States, 46227
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Robin Zon            
Hope Center Recruiting
Terre Haute, Indiana, United States, 47802
United States, Iowa
McFarland Clinic, P.C. Recruiting
Ames, Iowa, United States, 50010
Heartland Hematology-Oncology Associates, Inc. Recruiting
Council Bluffs, Iowa, United States, 51503
Siouxland Hematology/Oncology Assoc., LLP Recruiting
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas City Cancer Centers - Southwest Recruiting
Overland Park, Kansas, United States, 66210
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Commonwealth Cancer Center Recruiting
Danville, Kentucky, United States, 40422
Kentucky Cancer Clinic Recruiting
Hazard, Kentucky, United States, 41701
Kentuckianna Cancer Institute, PLLC Withdrawn
Louisville, Kentucky, United States, 40202
Oncology Associates of West Kentucky Withdrawn
Paducah, Kentucky, United States, 42003
Western Kentucky Hematology and Oncology Group Recruiting
Paducah, Kentucky, United States, 42003
Contact: William Skinner, MD            
United States, Louisiana
Christus St. Francis Cabrini Cancer Center Recruiting
Alexandria, Louisiana, United States, 71301
Hematology-Oncology Clinic Recruiting
Baton Rouge, Louisiana, United States, 70809
Jayne S. Gurtler, MD, Laura A. Brinz, MD, and Angelo Russo, MD APMC Withdrawn
Metairie, Louisiana, United States, 70006-2921
United States, Maine
Maine Center for Cancer Medicine & Blood Disorders Withdrawn
Sanford, Maine, United States, 04073
United States, Maryland
Annapolis Oncology Center Recruiting
Annapolis, Maryland, United States, 21401
Auerbach Hematology Oncology Associates Recruiting
Baltimore, Maryland, United States, 21237
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
St. Agnes Health Care Recruiting
Baltimore, Maryland, United States, 21229
Maryland Hematology Oncology Association Recruiting
Baltimore, Maryland, United States, 21237
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
Oncology-Hematology Associates, P.A. Recruiting
Clinton, Maryland, United States, 20735
Maryland Oncology Hematology, PA Recruiting
Columbia, Maryland, United States, 21044
Carroll County Cancer Center Recruiting
Westminster, Maryland, United States, 21157
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Fallon Clinic at Worcester Medical Center Recruiting
Worcester, Massachusetts, United States, 01608-1320
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Cancer & Hematology Centers of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49546
Kalamazoo Hematology and Oncology Recruiting
Kalamazoo, Michigan, United States, 49048
Oncology Care Associates, P.L.L.C. Recruiting
St. Joseph, Michigan, United States, 49085
Breslin Cancer Center / Great Lakes Cancer Institute Not yet recruiting
Lansing, Michigan, United States, 48910
Providence Cancer Center Recruiting
Southfield, Michigan, United States, 48075
Contact: Howard Terebelo            
Hematology Oncology Associates of Ohio & Michigan, PC Recruiting
Lambertville, Michigan, United States, 48144
Osteopathic Medical Hematology & Oncology Recruiting
Woodhaven, Michigan, United States, 48183
United States, Minnesota
St. Luke's Hospital Recruiting
Duluth, Minnesota, United States, 55805
Metro MN CCOP Recruiting
Minneapolis, Minnesota, United States, 55416
Hubert H. Humphrey Cancer Center Recruiting
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
Capital Region Medical Center/Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Ellis Fischel Cancer Center Withdrawn
Columbia, Missouri, United States, 65203
Missouri Cancer Associates Withdrawn
Columbia, Missouri, United States, 65201
St. Louis Cancer Center Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Daniel Cuevas            
Heartland Hematology-Oncology Associates, Inc. Recruiting
Kansas City, Missouri, United States, 64118
Kansas City Veterans Administration Medical Center Recruiting
Kansas City, Missouri, United States, 64128
St. Joseph Oncology Recruiting
St. Joseph, Missouri, United States, 64507
St. Louis Cancer and Breast Institute Withdrawn
St. Louis, Missouri, United States, 63141
Center for Cancer Care and Research Withdrawn
St. Louis, Missouri, United States, 63141
United States, Montana
Billings Clinic Withdrawn
Billings, Montana, United States, 59101
Hematology Oncology Centers of the Northern Rockies Withdrawn
Billings, Montana, United States, 59101
Great Falls Clinic, LLP Recruiting
Great Falls, Montana, United States, 59405
United States, Nebraska
Nebraska Cancer Care Withdrawn
Hastings, Nebraska, United States, 68901
Great Plains Regional Medical Center Recruiting
North Platte, Nebraska, United States, 69101
Hematology & Oncology Withdrawn
Omaha, Nebraska, United States, 68122
Creighton Cancer Center Not yet recruiting
Omaha, Nebraska, United States, 68131-2137
United States, Nevada
Las Vegas Cancer Center Recruiting
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Veterans Affairs New Jersey Healthcare System Recruiting
East Orange, New Jersey, United States, 07018
Contact: Shanthi Srinivas            
Drs. Forte, Schleider, Attas and Condemi, PA Recruiting
Englewood, New Jersey, United States, 07631
St. Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Newark Beth Israel Hospital Recruiting
Newark, New Jersey, United States, 07112
Contact: Susan Talbot            
Somerset Hematology Oncology Associates Recruiting
Somerville, New Jersey, United States, 08876
Contact: Steven Young            
Sparta Cancer Center Recruiting
Sparta, New Jersey, United States, 07871
United States, New Mexico
New Mexico Cancer Care Associates Recruiting
Santa Fe, New Mexico, United States, 87505
United States, New York
Erie County Medical Center Recruiting
Buffalo, New York, United States, 14215
Dr. Fernando J. Camacho, Private Practice Withdrawn
Bronx, New York, United States, 10467
Eastchester Center for Cancer Care Recruiting
Bronx, New York, United States, 10469
Stratton VA Medical Center IRB Recruiting
Albany, New York, United States, 12208
Contact: Donald Pasquale            
Buffalo Institute for Medical Research, Inc. Recruiting
Buffalo, New York, United States, 14215
Goshen Medical Associates Recruiting
Goshen, New York, United States, 10924
Huntington Medical Group Recruiting
Huntington Station, New York, United States, 11746
North Shore-Long Island Jewish Health System Recruiting
Lake Success, New York, United States, 11042
Arena Oncology Associates Recruiting
New Hyde Park, New York, United States, 11042
Richmond University Medical Center Recruiting
Staten Island, New York, United States, 10301
New York Presbyterian Hospital-Cornell Campus Recruiting
New York, New York, United States, 10021
Interlakes Foundation, Inc. Recruiting
Rochester, New York, United States, 14623
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Bernard Poiesz            
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Karen Seiter            
United States, North Carolina
Cancer Care of WNC Recruiting
Asheville, North Carolina, United States, 28801
Alamance Regional Medical Center Recruiting
Burlington, North Carolina, United States, 27215
Emerywood Hematology/Oncology Recruiting
High Point, North Carolina, United States, 27262
Gaston Hematology & Oncology Recruiting
Gastonia, North Carolina, United States, 28054
Carolina Oncology Specialist, PA Recruiting
Hickory, North Carolina, United States, 28603
Blood and Cancer Clinic Recruiting
Fayetteville, North Carolina, United States, 28304
Raleigh Hematology Oncology / Associates, P.C. Recruiting
Raleigh, North Carolina, United States, 27607
Hanover Medical Specialists, P.A. Recruiting
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Legacy Pharma Research Withdrawn
Bismarck, North Dakota, United States, 58501
St. Alexius Clinical Research Services Recruiting
Bismark, North Dakota, United States, 58501
United States, Ohio
Summa Health System Withdrawn
Akron, Ohio, United States, 44309
Oncology Hematology Care, Inc. Recruiting
Cincinnati, Ohio, United States, 45215
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Oncology Partners Network Recruiting
Cincinnati, Ohio, United States, 45247
Contact: James Maher            
Blood and Cancer Center, Inc. Withdrawn
Canfield, Ohio, United States, 44406
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Hematology Oncology Consultants Inc. Recruiting
Columbus, Ohio, United States, 43235
Dayton Clinical Oncology Program Recruiting
Dayton, Ohio, United States, 45429
Dayton Oncology & Hematology Recruiting
Kettering, Ohio, United States, 45409
Toledo Community Hospital Oncology Program Recruiting
Toledo, Ohio, United States, 43617
Trilogy Cancer Center Recruiting
Wooster, Ohio, United States, 44691
United States, Oklahoma
Cancer Care Associates Recruiting
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Oncology and Hematology Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Bend Memorial Clinic Withdrawn
Bend, Oregon, United States, 97701
Willamette Valley Cancer Center Recruiting
Eugene, Oregon, United States, 97401
Pacific Oncology Withdrawn
Portland, Oregon, United States, 97210
United States, Pennsylvania
Onc-Hem of Lehigh Valley, PC Recruiting
Bethlehem, Pennsylvania, United States, 18015
Regional Hematology Oncology Associates Recruiting
Langhorne, Pennsylvania, United States, 19047
Hematology & Oncology Associates of NEPA Recruiting
Dunmore, Pennsylvania, United States, 18512
Contact: William Jordan, MD            
Medical Oncology Associates Recruiting
Kingston, Pennsylvania, United States, 18704
Consultants in Medical Oncology & Hematology Withdrawn
Drexel Hill, Pennsylvania, United States, 19026
Greater Philadelphia Cancer and Hematology Specialists, PC Recruiting
Philadelphia, Pennsylvania, United States, 19114
UPMC Cancer Pavillioin Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Suzanne Lentzsch            
Guthrie Research Institute Recruiting
Sayre, Pennsylvania, United States, 18840
Scranton Hematology Oncology Recruiting
Scranton, Pennsylvania, United States, 18510
United States, Rhode Island
Roger Williams Medical Center Recruiting
Providence, Rhode Island, United States, 02908
Contact: Frank Cummings            
United States, South Carolina
MUSC Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Robert Stuart            
South Carolina Oncology Associates Withdrawn
Columbia, South Carolina, United States, 29210
Cancer Center of the Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Low Country Hematology & Oncology Recruiting
Mt. Pleasant, South Carolina, United States, 29464
Santee Hematology/Oncology Recruiting
Sumter, South Carolina, United States, 29150
United States, South Dakota
Avera Research Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Chattanooga Oncology Hematology Associates Recruiting
Chattanooga, Tennessee, United States, 37404
The Family Cancer Center, PLLC Recruiting
Collierville, Tennessee, United States, 38017
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
The Jones Clinic Recruiting
Germantown, Tennessee, United States, 38138
University of Tennesee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
East Tennessee Oncology/Hematology Recruiting
Knoxville, Tennessee, United States, 37920
The Cancer Center of Cookeville Regional Medical Center Recruiting
Cookeville, Tennessee, United States, 38501
United States, Texas
Texas Cancer Center Recruiting
Abilene, Texas, United States, 79606-5208
Texas Oncology, P.A. Recruiting
Arlington, Texas, United States, 76014
Southwest Regional Cancer Center Recruiting
Austin, Texas, United States, 78705
Texas Oncology, PA Recruiting
Austin, Texas, United States, 78731
Texas Oncology, PA Recruiting
Beaumont, Texas, United States, 77702
Texas Oncology, P.A. Recruiting
Bedford, Texas, United States, 76022
South Texas Institute of Cancer and Blood Disorders Recruiting
Corpus Christi, Texas, United States, 78405
Texas Cancer Center of Mesquite Recruiting
Mesquite, Texas, United States, 75150
Coastal Bend Cancer Center Recruiting
Corpus Christi, Texas, United States, 73112
Dallas Oncology Consultants Recruiting
Dallas, Texas, United States, 75237
Center for Oncology Research and Treatment, Pa Withdrawn
Dallas, Texas, United States, 75230
Texas Oncology, PA / Methodist Charlton Cancer Center Recruiting
Dallas, Texas, United States, 75237
Texas Oncology Recruiting
Dallas, Texas, United States, 75230-2510
Texas Oncology PA Recruiting
Dallas, Texas, United States, 75246
Texas Cancer Center Recruiting
Denton, Texas, United States, 76210
El Paso Cancer Treatment Center Recruiting
El Paso, Texas, United States, 79902
Texas Cancer Center Recruiting
Fort Worth, Texas, United States, 76104
Texas Oncology, PA Recruiting
Garland, Texas, United States, 75042
Lee C. Drinkard, MD Recruiting
Grapevine, Texas, United States, 76051
Medicus Alliance Clinical Research Organization, LLC Recruiting
Houston, Texas, United States, 77090
Houston Cancer Institute Recruiting
Houston, Texas, United States, 77055
Lake Vista Cancer Center Recruiting
Lewisville, Texas, United States, 75067
Longview Cancer Center Recruiting
Longview, Texas, United States, 75601
Cancer Specialists of South Texas, P.A. Withdrawn
Corpus Christi, Texas, United States, 78412
Texas Oncology, P.A. Recruiting
Midland, Texas, United States, 79701
Texas Oncology - Odessa Recruiting
Odessa, Texas, United States, 79761
Paris Regional Cancer Center Recruiting
Paris, Texas, United States, 75460
Cancer Care Center of South Texas Recruiting
San Antonio, Texas, United States, 78229
Cancer Care Network of South Texas Recruiting
San Antonio, Texas, United States, 78217
Tyler Hematology/Oncology, PA Recruiting
Tyler, Texas, United States, 75701
Texas Cancer Center - Sherman Recruiting
Sherman, Texas, United States, 75090
Blood and Cancer Center of East Texas Recruiting
Tyler, Texas, United States, 75701
CTRC Institute for Drug Development Recruiting
San Antonio, Texas, United States, 78245
Texas Oncology, PA Recruiting
Tyler, Texas, United States, 75702
Texas Oncology Recruiting
Waco, Texas, United States, 76712
United States, Utah
Northern Utah Associates Recruiting
Ogden, Utah, United States, 84403
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
United States, Vermont
The University of Vermont Recruiting
Burlington, Vermont, United States, 05401
White River Junction VAMC Recruiting
White River Junction, Vermont, United States, 05009-001
Contact: Stefan Balan, MD            
United States, Virginia
Cancer Specialists of Tidewater Recruiting
Chesapeake, Virginia, United States, 23320
Fairfax/Northern Virginia Hematology/Oncology Recruiting
Fairfax, Virginia, United States, 22031
Lynchburg Hematology Oncology Clinic, Inc. Recruiting
Lynchburg, Virginia, United States, 24501
Peninsula Cancer Institute Riverside Cancer Center Recruiting
Newport News, Virginia, United States, 23601
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23230
Oncology and Hematology Associates of Southwest Virginia, Inc. Recruiting
Salem, Virginia, United States, 24153
Masoom Kandahari, MD, PC Recruiting
Woodbridge, Virginia, United States, 22191
United States, Washington
Puget Sound Cancer Center - Edmonds Recruiting
Edmonds, Washington, United States, 98026
Providence Everett Medical Center Recruiting
Everett, Washington, United States, 98201
Puget Sound Cancer Center, Inc Recruiting
Seattle, Washington, United States, 98133
Cancer Care Northwest, US Oncology Recruiting
Spokane, Washington, United States, 99202
Northwest Medical Specialties, PLLC Recruiting
Tacoma, Washington, United States, 98405
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
Yakima Valley Memorial Hospital / North Star Lodge Recruiting
Yakima, Washington, United States, 98902
United States, Wisconsin
Gundersen Clinic, Ltd. Recruiting
La Crosse, Wisconsin, United States, 54601
Alyce & Elmore Kraemer Cancer Center Recruiting
West Bend, Wisconsin, United States, 53095
Puerto Rico
Hospital Auxillo Mutuo, Auxilio Mutuo Cancer Center Recruiting
San Juan, Puerto Rico, 00919-1227
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor )
Study ID Numbers: C05009
Study First Received: July 25, 2007
Last Updated: December 2, 2009
ClinicalTrials.gov Identifier: NCT00507416     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dexamethasone
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Angiogenesis Modulating Agents
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Hematologic Diseases
Glucocorticoids
Multiple Myeloma
Protease Inhibitors
Neoplasms
Leprostatic Agents
Melphalan
Thalidomide
Immunologic Factors
Blood Protein Disorders
Antineoplastic Agents
Paraproteinemias
Hemostatic Disorders
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 08, 2010