A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
NCT ID: NCT02612779
Last Updated: 2021-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2016-02-09
2020-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
Elotuzumab
Pomalidomide
Dexamethasone
Nivolumab
Elotuzumab + Nivolumab (EN)
Patients will receive treatment with a combination of elotuzumab and nivolumab
Elotuzumab
Nivolumab
Interventions
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Elotuzumab
Pomalidomide
Dexamethasone
Nivolumab
Eligibility Criteria
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Inclusion Criteria
2. ECOG Performance Status less than or equal to 2
3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
4. EPd Cohort:
* must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
* Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
5. EN Cohort:
* Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
Exclusion Criteria
2. Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
3. Subjects with Central Nervous System involvement with multiple myeloma
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Southern Cancer Center
Mobile, Alabama, United States
Sansum Clinic - USOR
Santa Barbara, California, United States
Colorado Blood Cancer Institute - PPDS
Denver, Colorado, United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, United States
Florida Cancer Specialists - EAST - SCRI - PPDS
St. Petersburg, Florida, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, United States
Illinois Cancer Care
Peoria, Illinois, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Bay Hematology Oncology
Easton, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Mount Sinai Medical Center
New York, New York, United States
Greenville Health System
Greenville, South Carolina, United States
Avera Health Care
Sioux Falls, South Dakota, United States
Jones Clinic PC
Germantown, Tennessee, United States
Tennessee Oncology NASH - SCRI - PPDS
Nashville, Tennessee, United States
Texas Oncology (Loop) - USOR
San Antonio, Texas, United States
Virginia Cancer Specialists (Leesburg) - USOR
Leesburg, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Aurora Health Care
Burlington, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA204-142
Identifier Type: -
Identifier Source: org_study_id
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