Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:May 18, 2011
End Date:May 31, 2019

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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

The purpose of the study is to determine whether the addition of Elotuzumab to
Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

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
We found this trial at
98
sites
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3700 Johnson Street
Hollywood, Florida 33021
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Hollywood, FL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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1660 South Columbian Way
Seattle, Washington 98108
(206) 762-1010
VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
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Bakersfield, California 93309
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Baltimore, Maryland 21237
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2450 Ashby Ave.
Berkeley, California 94705
(510) 204-4444
Alta Bates Summit Comprehensive Cancer Center Our Comprehensive Cancer Services are comprised of exceptional, state-of-the-art...
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Bethlehem, Pennsylvania 18015
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Birmingham, Alabama 35223
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Bloomington, Indiana 47403
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brooksville, Florida 34613
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Chandler, Arizona 85224
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Charleston, South Carolina 29403
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28211
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cleveland, Ohio 44195
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Columbus, Ohio 43210
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Columbus, Ohio 43219
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Corona, California 92879
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Corpus Christi, Texas 78412
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Detroit, Michigan 48202
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Fort Myers, Florida 33916
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Fredericksburg, Virginia 22408
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Goldsboro, North Carolina 27534
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Greenbrae, California 94904
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Greenville, South Carolina 29615
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Honolulu, Hawaii 96819
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Houston, Texas 77090
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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Huntington, West Virginia 25701
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Indianapolis, Indiana 46237
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Indianapolis, Indiana 46254
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32256
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Jefferson City, Missouri 65109
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Knoxville, Tennessee 37920
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La Crosse, Wisconsin 54601
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Langhorne, Pennsylvania 19047
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Lexington, Kentucky 40503
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Lincoln, Nebraska 68506
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Long Beach, California 90813
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Los Angeles, California 90095
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Louisville, Kentucky 40207
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Madison, Wisconsin 53717
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Marrero, Louisiana 70072
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Maywood, Illinois 60153
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Memphis, Tennessee 38120
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mishawaka, Indiana 46545
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Mobile, Alabama 36608
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1660 Springhill Avenue
Mobile, Alabama 36604
(251) 665-8000
University of South Alabama Mitchell Cancer Institute USA Mitchell Cancer Institute (MCI) is located in...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Orleans, Louisiana 70121
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New Port Richey, Florida 34652
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New York, New York 10016
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New York, New York 10021
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Orange, California 92868
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Peoria, Illinois 61615
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4800 Friendship Ave
Pittsburgh, Pennsylvania 15224
(412) 578-5000
Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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Pittsburgh, Pennsylvania 15240
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Petersburg, Florida 33705
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San Diego, California 92123
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San Francisco, California 94115
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Sayre, Pennsylvania 18840
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Shreveport, Louisiana 71103
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Skokie, Illinois 60076
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Springfield, Missouri 65807
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Washington, District of Columbia 20010
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West Palm Beach, Florida 33401
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Winston-Salem, North Carolina 27103
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