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A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma


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

Thank you

Trial Information

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma


Inclusion Criteria:



- Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

- have not received any prior systemic anti-myeloma therapy AND

- have measurable disease AND

- are not candidates for high-dose therapy plus stem-cell transplantation (SCT)
because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high
dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject <
65 years old. There must be a comorbidity that prevents SCT for a subject < 65
years old

Exclusion Criteria:

- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

- Monoclonal Gammopathy of Undetermined Significance (MGUS)

- Active plasma cell leukemia

- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment.

Outcome Time Frame:

Every 4 weeks (-1/+3 days) relative to the first dose of study medication.

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CA204-006

NCT ID:

NCT01335399

Start Date:

August 2011

Completion Date:

November 2018

Related Keywords:

  • Multiple Myeloma
  • Newly Diagnosed
  • Previously Untreated
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Columbia Comprehensive Cancer Care ClinicColumbia, Missouri  65201
Florida Cancer SpecialistsFort Myers, Florida  33901
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Medical Oncology Care AssociatesOrange, California  92668
Cancer Care AssociatesTulsa, Oklahoma  74136
Henry Ford Health SystemDetroit, Michigan  48202
Cleveland ClinicCleveland, Ohio  44195
Local InstitutionChicago, Illinois  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionVancouver, Washington  
Local InstitutionGreen Bay, Wisconsin  
ACRC/Arizona Clinical Research Center, Inc.Tucson, Arizona  85712
Local InstitutionCorona, California  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionRome, Georgia  
Local InstitutionNew Orleans, Louisiana  
Cancer Specialists of South Texas, PACorpus Christi, Texas  78412
Virginia Commonwealth UniversityRichmond, Virginia  
Yale University School Of MedicineNew Haven, Connecticut  06520
Sharp Clinical Oncology ResearchSan Diego, California  92123
The University of ChicagoChicago, Illinois  60637
St. Luke's-Roosevelt Hospital CenterNew York, New York  
Edwards Comprehensive Cancer CenterHuntington, West Virginia  25701
Local InstitutionLouisville, Kentucky  
Tennessee Oncology, PLLCClarksville, Tennessee  37043
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Local InstitutionDetroit, Michigan  
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Stony Brook University Medical CenterStony Brook, New York  11794
Northwest Cancer CenterHouston, Texas  77042
St. Luke's Roosevelt Hospital CenterNew York, New York  10019
Mecklenburg Medical GroupCharlotte, North Carolina  
Charleston Hematology Oncology Associates, PACharleston, South Carolina  29403
Michiana Hematology Oncology, P.C.South Bend, Indiana  46601
Birmingham Hematology & Oncology Associates LlcBirmingham, Alabama  35205
Compassionate Cancer Care Medical Group IncFountain Valley, California  92708
Piedmont Hematology Oncology Associates, PAWinston Salem, North Carolina  27103
Marin Cancer Care, IncGreenbrae, California  94904
Cancer Center Of Acadiana At Lafayette GeneralLafayette, Louisiana  70503
Hematology-Oncology Associates Of Fredricksburg, IncFredricksburg, Virginia  22408
Cancer Care Centers Of FloridaBrooksville, Florida  34613
Harry & Jeanette Weinberg Cancer InstituteBaltimore, Maryland  21237
Mercy Medical Research InstituteSpringfield, Missouri  65807
Benson, Md, DonColumbus, Ohio  43210
Gundersen Clinic, LtdLa Crosse, Wisconsin  54601
Dean Clinic-Hematology And OncologyMadison, Wisconsin  53717