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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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consent may be withdrawn by the subject at any time without prejudice to future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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival.

Outcome Time Frame:

Up to 3 years after treatment is completed

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Institutional Review Board

Study ID:

C05009

NCT ID:

NCT00507416

Start Date:

June 2007

Completion Date:

May 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Memorial Hospital of South Bend South Bend, Indiana  46601
New York Medical College Valhalla, New York  10595
University Hospitals of Cleveland Cleveland, Ohio  44106
St. Barnabas Medical Center Livingston, New Jersey  07039
Texas Oncology, P.A. Dallas, Texas  75246
Boston Medical Center Boston, Massachusetts  02118
Sutter Cancer Center Sacramento, California  95816
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Southwest Regional Cancer Center Austin, Texas  78705
Roger Williams Medical Center Providence, Rhode Island  02908-4735
Virginia Oncology Associates Newport News, Virginia  23606
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Rocky Mountain Cancer Center Denver, Colorado  80218
Hubert H. Humphrey Cancer Center Coon Rapids, Minnesota  55433
Ocala Oncology Center Ocala, Florida  34474
Florida Cancer Specialists Fort Myers, Florida  33901
Great Plains Regional Medical Center North Platte, Nebraska  69101-6598
McFarland Clinic, P.C. Ames, Iowa  50010
Oncology Care Associates, P.L.L.C. Saint Joseph, Michigan  49085
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Cancer Care Center New Albany, Indiana  47150
Arena Oncology Associates Great Neck, New York  11021
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
St. Luke's Hospital Duluth, Minnesota  55805-2193
Fallon Clinic at Worcester Medical Center Worcester, Massachusetts  01608
Greater Baltimore Medical Center Baltimore, Maryland  21204
Southwest Cancer Care Poway, California  92064
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Hope Center Terre Haute, Indiana  47809
Medical Oncology Care Associates Orange, California  92668
Cancer Care Associates Tulsa, Oklahoma  74136
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
Elmhurst Memorial Hospital Elmhurst, Illinois  60126
SUNY Upstate Medical University Syracuse, New York  13210
Tower Cancer Research Foundation Beverly Hills, California  90211
Hematology Oncology Services of Arkansas Little Rock, Arkansas  72205
Northern Utah Associates Ogden, Utah  84403
Oncology-Hematology Associates, P.A. Clinton, Maryland  20735
Henry Ford Health System Detroit, Michigan  48202
Hematology-Oncology Clinic Baton Rouge, Louisiana  70808
Arizona Oncology Associates Tucson, Arizona  85712-2254
Lakeland Regional Cancer Center Lakeland, Florida  33805
Goshen Medical Associates Goshen, New York  10924
Northwest Medical Specialties, PLLC Tacoma, Washington  98405
University of Chicago Chicago, Illinois  60637
Oncology Hematology Care, Inc. Cincinnati, Ohio  45219
St. Joseph Oncology St. Joseph, Missouri  64507
Hematology Oncology Associates of Illinois Skokie, Illinois  60077
Cancer Care Associates Fresno, California  93720
Cancer Centers of Florida, P.A. Orlando, Florida  
Texas Oncology Dallas, Texas  
California Cancer Care Greenbrae, California  94904
Innovative Medical Research of South Florida Inc. Miami Shores, Florida  33138
Medical Consultants, PC Muncie, Indiana  47304
Gabrail Cancer Center Canton, Ohio  44718
Virginia Cancer Institute Richmond, Virginia  23230
Erie County Medical Center Buffalo, New York  14215
Eastchester Center for Cancer Care Bronx, New York  10469
Avera Research Institute Sioux Falls, South Dakota  57105
Oncology Partners Network Cincinnati, Ohio  45238
Dayton Clinical Oncology Program Dayton, Ohio  45420
Texas Oncology, PA Dallas, Texas  75246-2006
Utah Cancer Specialists Salt Lake City, Utah  84106
Compassionate Cancer Care medical Group, Inc. Fountain Valley, California  92708
Cancer & Hematology Centers of Western Michigan Grand Rapids, Michigan  49546
Medical Oncology Associates Kingston, Pennsylvania  18704
Florida Cancer Institute New Port Richey, Florida  34652
Medical Oncology Associates of Augusta Augusta, Georgia  30901
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Somerset Hematology Oncology Associates Somerset, New Jersey  08873
Santee Hematology/Oncology Sumter, South Carolina  29150
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Las Vegas Cancer Center Las Vegas, Nevada  89102
Northwest Georgia Oncology Centers, P.C. Marietta, Georgia  30060
Annapolis Oncology Center Annapolis, Maryland  21401
Providence Cancer Center Southfield, Michigan  48075
Cancer Center of the Carolinas Greenville, South Carolina  29615
The Jones Clinic Germantown, Tennessee  38138
The Center for Hematology-Oncology Boca Raton, Florida  33486
Joliet Oncology-Hematology Associates, Ltd. Flossmoor, Illinois  60422
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Hematology & Oncology Associates of NEPA Dunmore, Pennsylvania  18512
Dallas Oncology Consultants Dallas, Texas  75201
Cancer & Blood Disease Center Lecanto, Florida  34461
Kansas City Cancer Centers - Southwest Overland Park, Kansas  66210
Texas Cancer Center Abilene, Texas  79606
El Paso Cancer Treatment Center El Paso, Texas  79915
Lake Vista Cancer Center Lewisville, Texas  75067
Longview Cancer Center Longview, Texas  75601
Texas Cancer Center of Mesquite Mesquite, Texas  75150
Puget Sound Cancer Center - Edmonds Edmonds, Washington  98026
Pasco Hernando Oncology New Port Richey, Florida  34652
Alamance Regional Medical Center Burlington, North Carolina  27216
Scranton Hematology Oncology Scranton, Pennsylvania  18510
Dayton Oncology & Hematology Kettering, Ohio  45409
Clinical Trials and Research Associates, Inc. Montebello, California  60460
Auerbach Hematology Oncology Associates Baltimore, Maryland  21237
Greater Philadelphia Cancer and Hematology Specialists, PC Philadelphia, Pennsylvania  19114
St. Agnes Health Care Baltimore, Maryland  21229
Providence Everett Medical Center Everett, Washington  98201
Desert Oasis Cancer Center Casa Grande, Arizona  85222
Cancer Center of Kansas Wichita, Kansas  67214
Gulfcoast Oncology Associates St. Petersburg, Florida  33705
Blood and Cancer Center of East Texas Tyler, Texas  75701
Paris Regional Cancer Center Paris, Texas  75460
Texas Cancer Center - Sherman Sherman, Texas  75090-0504
Baptist Cancer Institute Jacksonville, Florida  32207
Great Falls Clinic, LLP Great Falls, Montana  59405
Cancer Care Network of South Texas San Antonio, Texas  78229
Cancer Research & Prevention Center Soquel, California  95073
Kalamazoo Hematology and Oncology Kalamazoo, Michigan  49048
Cancer Care of WNC Asheville, North Carolina  28801
Lynchburg Hematology Oncology Clinic, Inc. Lynchburg, Virginia  24501
Sarah Cannon Research Institute Nashville, Tennessee  37203
Ventura County Hematology Oncology Specialists Oxnard, California  93030
Christiana Care Health Services Newark, Delaware  19713
Huntington Medical Group Huntington Station, New York  11746
The Family Cancer Center, PLLC Collierville, Tennessee  38017
Coastal Bend Cancer Center Corpus Christi, Texas  78404
Compassionate Cancer Care Medical Group Corona, California  92882
Investigative Clinical Research of Indiana, LLC Indianapolis, Indiana  46254
Trilogy Cancer Center Wooster, Ohio  44691
MUSC Hollings Cancer Center Charleston, South Carolina  29425
New York Presbyterian Hospital-Cornell Campus New York, New York  10021
Interlakes Foundation, Inc. Rochester, New York  14623
Cancer Care of North Florida Lake City, Florida  32055
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404
Cancer Care & Hematology Specialists of Chicagoland Niles, Illinois  60714
Robert A. Moss, MD, FACP, Inc. Fountain Valley, California  92708
Maryland Oncology Hematology, PA Columbia, Maryland  21044
Masoom Kandahari, MD, PC Woodbridge, Virginia  22191
Texas Oncology PA Dallas, Texas  75231
Commonwealth Cancer Center Danville, Kentucky  40422
Cancer Care Center of South Texas San Antonio, Texas  78229
Richmond University Medical Center Staten Island, New York  10310-1699
Glendale Memorial Hospital & Health Center Glendale, California  
Stockton Hematology/Oncology Stockton, California  95204
Summit Cancer Care Savannah, Georgia  31405
Carroll County Cancer Center Westminster, Maryland  21157
Cancer Center of Central Connecticut Southington, Connecticut  
St. Lukes Mountain States Tumor Institute Boise, Idaho  83712
Toledo Community Hospital Oncology Program Toledo, Ohio  43617
Cancer Specialists of Tidewater Chesapeake, Virginia  
Hematology Oncology Consultants Inc. Columbus, Ohio  43228
Central Georgia Cancer Care Macon, Georgia  31201
Northwest Oncology & Hematology Associates Coral Spring, Florida  33065
Horizon Institute for Clinical Research Hollywood, Florida  33021
Emerywood Hematology/Oncology High Point, North Carolina  27262
Quincy Medical Group Quincy, Illinois  62301
Birmingham Hematology Oncology Assciates, LLC Birmingham, Alabama  35205
Northern Arizona Hematology & Oncology Associates - AOA Sedona, Arizona  86336
Heritage Physician Group Oncology Hot Springs, Arkansas  71913
Pacific Cancer Medical Centre Anaheim, California  92801
Beaver Medical Group Highland, California  92346
Edward A. Wagner, MD Laguna Beach, California  92882
Desert Cancer Care, Incorporated Rancho Mirage, California  92270
Trivalley Oncology Hematology Westlake Village, California  91361
University of Florida- Jacksonville Jacksonville, Florida  32209
Hematology Oncology Associates of the Treasure Coast, PA Port St. Lucie, Florida  34952
S. Florida Oncology/ Hematology West Palm Beach, Florida  33458
Snake River Oncology of Eastern Idaho, PLLC. Idaho Falls, Idaho  83404
Oncology Hematology Associates of North Illinois Ltd. Gurnee, Illinois  60031-3399
Midwest Center for Hematology / Oncology Joliet, Illinois  60432
Hematology Oncology Consultants, Inc. Naperville, Illinois  60540
Cancer Care and Hematology Specialists of Chicagoland Niles, Illinois  60714
Mid-Illinois Hem & Onc Normal, Illinois  61761
Deaconess Clinic Incorporated Evansville, Indiana  47713
Clarian Arnett Cancer Center Lafayette, Indiana  47904
Heartland Hematology-Oncology Associates, Inc. Council Bluffs, Iowa  51503
Siouxland Hematology/Oncology Assoc., LLP Sioux City, Iowa  51101
Western Kentucky Hematology and Oncology Group Paducah, Kentucky  42003
Christus St. Francis Cabrini Cancer Center Alexandria, Louisiana  71301
Maryland Hematology Oncology Association Baltimore, Maryland  21237
Hematology Oncology Associates of Ohio & Michigan, PC Lambertville, Michigan  48144
Breslin Cancer Center / Great Lakes Cancer Institute Lansing, Michigan  48910
Osteopathic Medical Hematology & Oncology Woodhaven, Michigan  48183
Metro MN CCOP Minneapolis, Minnesota  55416
St. Louis Cancer Center Chesterfield, Missouri  63017
Capital Region Medical Center/Cancer Center Jefferson City, Missouri  65109
Heartland Hematology-Oncology Associates, Inc. Kansas City, Missouri  64118
Kansas City Veterans Administration Medical Center Kansas City, Missouri  64128
Creighton Cancer Center Omaha, Nebraska  68131-2137
Veterans Affairs New Jersey Healthcare System East Orange, New Jersey  07018
Drs. Forte, Schleider, Attas and Condemi, PA Englewood, New Jersey  07631
Newark Beth Israel Hospital Newark, New Jersey  07112
Sparta Cancer Center Sparta, New Jersey  07871
Stratton VA Medical Center IRB Albany, New York  12208
Buffalo Institute for Medical Research, Inc. Buffalo, New York  14215
North Shore-Long Island Jewish Health System Lake Success, New York  11042
Blood and Cancer Clinic Fayetteville, North Carolina  28304
Gaston Hematology & Oncology Gastonia, North Carolina  28054
Carolina Oncology Specialist, PA Hickory, North Carolina  28603
Raleigh Hematology Oncology / Associates, P.C. Raleigh, North Carolina  27607
Hanover Medical Specialists, P.A. Wilmington, North Carolina  28401
St. Alexius Clinical Research Services Bismark, North Dakota  58501
Oklahoma Oncology and Hematology Tulsa, Oklahoma  74136
Onc-Hem of Lehigh Valley, PC Bethlehem, Pennsylvania  18015
Regional Hematology Oncology Associates Langhorne, Pennsylvania  19047
UPMC Cancer Pavillioin Pittsburgh, Pennsylvania  15232
Guthrie Research Institute Sayre, Pennsylvania  18840
Low Country Hematology & Oncology Mt. Pleasant, South Carolina  29464
The Cancer Center of Cookeville Regional Medical Center Cookeville, Tennessee  38501
University of Tennesee Medical Center Knoxville, Tennessee  37920
East Tennessee Oncology/Hematology Knoxville, Tennessee  37920
South Texas Institute of Cancer and Blood Disorders Corpus Christi, Texas  78405
Texas Oncology, PA / Methodist Charlton Cancer Center Dallas, Texas  75237
Lee C. Drinkard, MD Grapevine, Texas  76051
Medicus Alliance Clinical Research Organization, LLC Houston, Texas  77090
Houston Cancer Institute Houston, Texas  77055
Texas Oncology - Odessa Odessa, Texas  79761
CTRC Institute for Drug Development San Antonio, Texas  78245
Tyler Hematology/Oncology, PA Tyler, Texas  75701
The University of Vermont Burlington, Vermont  05401
White River Junction VAMC White River Junction, Vermont  05009-001
Fairfax/Northern Virginia Hematology/Oncology Fairfax, Virginia  22031
Peninsula Cancer Institute Riverside Cancer Center Newport News, Virginia  23601
Puget Sound Cancer Center, Inc Seattle, Washington  98133
Cancer Care Northwest, US Oncology Spokane, Washington  99202
Yakima Valley Memorial Hospital / North Star Lodge Yakima, Washington  98902
Gundersen Clinic, Ltd. La Crosse, Wisconsin  54601
Alyce & Elmore Kraemer Cancer Center West Bend, Wisconsin  53095