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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consent may be withdrawn by the subject at any time without prejudice to future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 CenterNew York, New York  10021
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Memorial Hospital of South BendSouth Bend, Indiana  46601
New York Medical CollegeValhalla, New York  10595
University Hospitals of ClevelandCleveland, Ohio  44106
St. Barnabas Medical CenterLivingston, New Jersey  07039
Texas Oncology, P.A.Dallas, Texas  75246
Boston Medical CenterBoston, Massachusetts  02118
Sutter Cancer CenterSacramento, California  95816
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Southwest Regional Cancer CenterAustin, Texas  78705
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Rocky Mountain Cancer CenterDenver, Colorado  80218
Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Ocala Oncology CenterOcala, Florida  34474
Florida Cancer SpecialistsFort Myers, Florida  33901
Great Plains Regional Medical CenterNorth 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 CenterWenatchee, Washington  98801-2028
Cancer Care CenterNew Albany, Indiana  47150
Arena Oncology AssociatesGreat Neck, New York  11021
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
St. Luke's HospitalDuluth, Minnesota  55805-2193
Fallon Clinic at Worcester Medical CenterWorcester, Massachusetts  01608
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Southwest Cancer CarePoway, California  92064
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Hope CenterTerre Haute, Indiana  47809
Medical Oncology Care AssociatesOrange, California  92668
Cancer Care AssociatesTulsa, Oklahoma  74136
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
Elmhurst Memorial HospitalElmhurst, Illinois  60126
SUNY Upstate Medical UniversitySyracuse, New York  13210
Tower Cancer Research FoundationBeverly Hills, California  90211
Hematology Oncology Services of ArkansasLittle Rock, Arkansas  72205
Northern Utah AssociatesOgden, Utah  84403
Oncology-Hematology Associates, P.A.Clinton, Maryland  20735
Henry Ford Health SystemDetroit, Michigan  48202
Hematology-Oncology ClinicBaton Rouge, Louisiana  70808
Arizona Oncology AssociatesTucson, Arizona  85712-2254
Lakeland Regional Cancer CenterLakeland, Florida  33805
Goshen Medical AssociatesGoshen, New York  10924
Northwest Medical Specialties, PLLCTacoma, Washington  98405
University of ChicagoChicago, Illinois  60637
Oncology Hematology Care, Inc.Cincinnati, Ohio  45219
St. Joseph OncologySt. Joseph, Missouri  64507
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
Cancer Care AssociatesFresno, California  93720
Cancer Centers of Florida, P.A.Orlando, Florida  
Texas OncologyDallas, Texas  
California Cancer CareGreenbrae, California  94904
Innovative Medical Research of South Florida Inc.Miami Shores, Florida  33138
Medical Consultants, PCMuncie, Indiana  47304
Gabrail Cancer CenterCanton, Ohio  44718
Virginia Cancer InstituteRichmond, Virginia  23230
Erie County Medical CenterBuffalo, New York  14215
Eastchester Center for Cancer CareBronx, New York  10469
Avera Research InstituteSioux Falls, South Dakota  57105
Oncology Partners NetworkCincinnati, Ohio  45238
Dayton Clinical Oncology ProgramDayton, Ohio  45420
Texas Oncology, PADallas, Texas  75246-2006
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan  49546
Medical Oncology AssociatesKingston, Pennsylvania  18704
Florida Cancer InstituteNew Port Richey, Florida  34652
Medical Oncology Associates of AugustaAugusta, Georgia  30901
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Somerset Hematology Oncology AssociatesSomerset, New Jersey  08873
Santee Hematology/OncologySumter, South Carolina  29150
Kentucky Cancer ClinicPikeville, Kentucky  41501
Las Vegas Cancer CenterLas Vegas, Nevada  89102
Northwest Georgia Oncology Centers, P.C.Marietta, Georgia  30060
Annapolis Oncology CenterAnnapolis, Maryland  21401
Providence Cancer CenterSouthfield, Michigan  48075
Cancer Center of the CarolinasGreenville, South Carolina  29615
The Jones ClinicGermantown, Tennessee  38138
The Center for Hematology-OncologyBoca Raton, Florida  33486
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Hematology & Oncology Associates of NEPADunmore, Pennsylvania  18512
Dallas Oncology ConsultantsDallas, Texas  75201
Cancer & Blood Disease CenterLecanto, Florida  34461
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Texas Cancer CenterAbilene, Texas  79606
El Paso Cancer Treatment CenterEl Paso, Texas  79915
Lake Vista Cancer CenterLewisville, Texas  75067
Longview Cancer CenterLongview, Texas  75601
Texas Cancer Center of MesquiteMesquite, Texas  75150
Puget Sound Cancer Center - EdmondsEdmonds, Washington  98026
Pasco Hernando OncologyNew Port Richey, Florida  34652
Alamance Regional Medical CenterBurlington, North Carolina  27216
Scranton Hematology OncologyScranton, Pennsylvania  18510
Dayton Oncology & HematologyKettering, Ohio  45409
Clinical Trials and Research Associates, Inc.Montebello, California  60460
Auerbach Hematology Oncology AssociatesBaltimore, Maryland  21237
Greater Philadelphia Cancer and Hematology Specialists, PCPhiladelphia, Pennsylvania  19114
St. Agnes Health CareBaltimore, Maryland  21229
Providence Everett Medical CenterEverett, Washington  98201
Desert Oasis Cancer CenterCasa Grande, Arizona  85222
Cancer Center of KansasWichita, Kansas  67214
Gulfcoast Oncology AssociatesSt. Petersburg, Florida  33705
Blood and Cancer Center of East TexasTyler, Texas  75701
Paris Regional Cancer CenterParis, Texas  75460
Texas Cancer Center - ShermanSherman, Texas  75090-0504
Baptist Cancer InstituteJacksonville, Florida  32207
Great Falls Clinic, LLPGreat Falls, Montana  59405
Cancer Care Network of South TexasSan Antonio, Texas  78229
Cancer Research & Prevention CenterSoquel, California  95073
Kalamazoo Hematology and OncologyKalamazoo, Michigan  49048
Cancer Care of WNCAsheville, North Carolina  28801
Lynchburg Hematology Oncology Clinic, Inc.Lynchburg, Virginia  24501
Sarah Cannon Research InstituteNashville, Tennessee  37203
Ventura County Hematology Oncology SpecialistsOxnard, California  93030
Christiana Care Health ServicesNewark, Delaware  19713
Huntington Medical GroupHuntington Station, New York  11746
The Family Cancer Center, PLLCCollierville, Tennessee  38017
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
Compassionate Cancer Care Medical GroupCorona, California  92882
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Trilogy Cancer CenterWooster, Ohio  44691
MUSC Hollings Cancer CenterCharleston, South Carolina  29425
New York Presbyterian Hospital-Cornell CampusNew York, New York  10021
Interlakes Foundation, Inc.Rochester, New York  14623
Cancer Care of North FloridaLake City, Florida  32055
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Robert A. Moss, MD, FACP, Inc.Fountain Valley, California  92708
Maryland Oncology Hematology, PAColumbia, Maryland  21044
Masoom Kandahari, MD, PCWoodbridge, Virginia  22191
Texas Oncology PADallas, Texas  75231
Commonwealth Cancer CenterDanville, Kentucky  40422
Cancer Care Center of South TexasSan Antonio, Texas  78229
Richmond University Medical CenterStaten Island, New York  10310-1699
Glendale Memorial Hospital & Health CenterGlendale, California  
Stockton Hematology/OncologyStockton, California  95204
Summit Cancer CareSavannah, Georgia  31405
Carroll County Cancer CenterWestminster, Maryland  21157
Cancer Center of Central ConnecticutSouthington, Connecticut  
St. Lukes Mountain States Tumor InstituteBoise, Idaho  83712
Toledo Community Hospital Oncology ProgramToledo, Ohio  43617
Cancer Specialists of TidewaterChesapeake, Virginia  
Hematology Oncology Consultants Inc.Columbus, Ohio  43228
Central Georgia Cancer CareMacon, Georgia  31201
Northwest Oncology & Hematology AssociatesCoral Spring, Florida  33065
Horizon Institute for Clinical ResearchHollywood, Florida  33021
Emerywood Hematology/OncologyHigh Point, North Carolina  27262
Quincy Medical GroupQuincy, Illinois  62301
Birmingham Hematology Oncology Assciates, LLCBirmingham, Alabama  35205
Northern Arizona Hematology & Oncology Associates - AOASedona, Arizona  86336
Heritage Physician Group OncologyHot Springs, Arkansas  71913
Pacific Cancer Medical CentreAnaheim, California  92801
Beaver Medical GroupHighland, California  92346
Edward A. Wagner, MDLaguna Beach, California  92882
Desert Cancer Care, IncorporatedRancho Mirage, California  92270
Trivalley Oncology HematologyWestlake Village, California  91361
University of Florida- JacksonvilleJacksonville, Florida  32209
Hematology Oncology Associates of the Treasure Coast, PAPort St. Lucie, Florida  34952
S. Florida Oncology/ HematologyWest 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 / OncologyJoliet, Illinois  60432
Hematology Oncology Consultants, Inc.Naperville, Illinois  60540
Cancer Care and Hematology Specialists of ChicagolandNiles, Illinois  60714
Mid-Illinois Hem & OncNormal, Illinois  61761
Deaconess Clinic IncorporatedEvansville, Indiana  47713
Clarian Arnett Cancer CenterLafayette, Indiana  47904
Heartland Hematology-Oncology Associates, Inc.Council Bluffs, Iowa  51503
Siouxland Hematology/Oncology Assoc., LLPSioux City, Iowa  51101
Western Kentucky Hematology and Oncology GroupPaducah, Kentucky  42003
Christus St. Francis Cabrini Cancer CenterAlexandria, Louisiana  71301
Maryland Hematology Oncology AssociationBaltimore, Maryland  21237
Hematology Oncology Associates of Ohio & Michigan, PCLambertville, Michigan  48144
Breslin Cancer Center / Great Lakes Cancer InstituteLansing, Michigan  48910
Osteopathic Medical Hematology & OncologyWoodhaven, Michigan  48183
Metro MN CCOPMinneapolis, Minnesota  55416
St. Louis Cancer CenterChesterfield, Missouri  63017
Capital Region Medical Center/Cancer CenterJefferson City, Missouri  65109
Heartland Hematology-Oncology Associates, Inc.Kansas City, Missouri  64118
Kansas City Veterans Administration Medical CenterKansas City, Missouri  64128
Creighton Cancer CenterOmaha, Nebraska  68131-2137
Veterans Affairs New Jersey Healthcare SystemEast Orange, New Jersey  07018
Drs. Forte, Schleider, Attas and Condemi, PAEnglewood, New Jersey  07631
Newark Beth Israel HospitalNewark, New Jersey  07112
Sparta Cancer CenterSparta, New Jersey  07871
Stratton VA Medical Center IRBAlbany, New York  12208
Buffalo Institute for Medical Research, Inc.Buffalo, New York  14215
North Shore-Long Island Jewish Health SystemLake Success, New York  11042
Blood and Cancer ClinicFayetteville, North Carolina  28304
Gaston Hematology & OncologyGastonia, North Carolina  28054
Carolina Oncology Specialist, PAHickory, 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 ServicesBismark, North Dakota  58501
Oklahoma Oncology and HematologyTulsa, Oklahoma  74136
Onc-Hem of Lehigh Valley, PCBethlehem, Pennsylvania  18015
Regional Hematology Oncology AssociatesLanghorne, Pennsylvania  19047
UPMC Cancer PavillioinPittsburgh, Pennsylvania  15232
Guthrie Research InstituteSayre, Pennsylvania  18840
Low Country Hematology & OncologyMt. Pleasant, South Carolina  29464
The Cancer Center of Cookeville Regional Medical CenterCookeville, Tennessee  38501
University of Tennesee Medical CenterKnoxville, Tennessee  37920
East Tennessee Oncology/HematologyKnoxville, Tennessee  37920
South Texas Institute of Cancer and Blood DisordersCorpus Christi, Texas  78405
Texas Oncology, PA / Methodist Charlton Cancer CenterDallas, Texas  75237
Lee C. Drinkard, MDGrapevine, Texas  76051
Medicus Alliance Clinical Research Organization, LLCHouston, Texas  77090
Houston Cancer InstituteHouston, Texas  77055
Texas Oncology - OdessaOdessa, Texas  79761
CTRC Institute for Drug DevelopmentSan Antonio, Texas  78245
Tyler Hematology/Oncology, PATyler, Texas  75701
The University of VermontBurlington, Vermont  05401
White River Junction VAMCWhite River Junction, Vermont  05009-001
Fairfax/Northern Virginia Hematology/OncologyFairfax, Virginia  22031
Peninsula Cancer Institute Riverside Cancer CenterNewport News, Virginia  23601
Puget Sound Cancer Center, IncSeattle, Washington  98133
Cancer Care Northwest, US OncologySpokane, Washington  99202
Yakima Valley Memorial Hospital / North Star LodgeYakima, Washington  98902
Gundersen Clinic, Ltd.La Crosse, Wisconsin  54601
Alyce & Elmore Kraemer Cancer CenterWest Bend, Wisconsin  53095