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 |
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)
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
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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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
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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St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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VA Puget Sound Health Care System With a reputation for excellence, innovation and extraordinary care...
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1100 Fairview Avenue North
Seattle, Washington 98109
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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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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2450 Ashby Ave.
Berkeley, California 94705
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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1515 Holcombe Blvd
Houston, Texas 77030
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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Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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600 Highland Ave
Madison, Wisconsin 53792
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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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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1660 Springhill Avenue
Mobile, Alabama 36604
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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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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