Know Cancer

forgot password

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
Open (Enrolling)
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:


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:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

August 2011

Completion Date:

November 2018

Related Keywords:

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



University of Michigan Ann Arbor, Michigan  48109-0624
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Washington University School of Medicine Saint Louis, Missouri  63110
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Washington Cancer Institute at Washington Hospital Center Washington, District of Columbia  20010
Columbia Comprehensive Cancer Care Clinic Columbia, Missouri  65201
Florida Cancer Specialists Fort Myers, Florida  33901
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Greater Baltimore Medical Center Baltimore, Maryland  21204
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Tennessee Cancer Specialists Knoxville, Tennessee  37920
Medical Oncology Care Associates Orange, California  92668
Cancer Care Associates Tulsa, Oklahoma  74136
Henry Ford Health System Detroit, Michigan  48202
Cleveland Clinic Cleveland, Ohio  44195
Local Institution Chicago, Illinois  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Vancouver, Washington  
Local Institution Green Bay, Wisconsin  
ACRC/Arizona Clinical Research Center, Inc. Tucson, Arizona  85712
Local Institution Corona, California  
Local Institution Springfield, Massachusetts  
Local Institution Duncansville, Pennsylvania  
Local Institution North Charleston, South Carolina  
Local Institution Rome, Georgia  
Local Institution New Orleans, Louisiana  
Cancer Specialists of South Texas, PA Corpus Christi, Texas  78412
Virginia Commonwealth University Richmond, Virginia  
Yale University School Of Medicine New Haven, Connecticut  06520
Sharp Clinical Oncology Research San Diego, California  92123
The University of Chicago Chicago, Illinois  60637
St. Luke's-Roosevelt Hospital Center New York, New York  
Edwards Comprehensive Cancer Center Huntington, West Virginia  25701
Local Institution Louisville, Kentucky  
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
Local Institution Detroit, Michigan  
Investigative Clinical Research of Indiana, LLC Indianapolis, Indiana  46254
Stony Brook University Medical Center Stony Brook, New York  11794
Northwest Cancer Center Houston, Texas  77042
St. Luke's Roosevelt Hospital Center New York, New York  10019
Mecklenburg Medical Group Charlotte, North Carolina  
Charleston Hematology Oncology Associates, PA Charleston, South Carolina  29403
Michiana Hematology Oncology, P.C. South Bend, Indiana  46601
Birmingham Hematology & Oncology Associates Llc Birmingham, Alabama  35205
Compassionate Cancer Care Medical Group Inc Fountain Valley, California  92708
Piedmont Hematology Oncology Associates, PA Winston Salem, North Carolina  27103
Marin Cancer Care, Inc Greenbrae, California  94904
Cancer Center Of Acadiana At Lafayette General Lafayette, Louisiana  70503
Hematology-Oncology Associates Of Fredricksburg, Inc Fredricksburg, Virginia  22408
Cancer Care Centers Of Florida Brooksville, Florida  34613
Harry & Jeanette Weinberg Cancer Institute Baltimore, Maryland  21237
Mercy Medical Research Institute Springfield, Missouri  65807
Benson, Md, Don Columbus, Ohio  43210
Gundersen Clinic, Ltd La Crosse, Wisconsin  54601
Dean Clinic-Hematology And Oncology Madison, Wisconsin  53717