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.
A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
1 other identifier
interventional
74
1 country
22
Brief Summary
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Feb 2016
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2015
CompletedFirst Posted
Study publicly available on registry
November 24, 2015
CompletedStudy Start
First participant enrolled
February 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2020
CompletedResults Posted
Study results publicly available
August 6, 2020
CompletedJuly 2, 2021
June 1, 2021
3.5 years
November 20, 2015
July 23, 2020
June 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS)
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first. Progression is determined per International Myeloma Working Group (IMWG) uniform criteria. Participants who die without a reported prior progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date. Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
From first dose to study completion date (up to approximately 50 months)
Objective Response Rate (ORR)
ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
From first dose to study completion date (up to approximately 50 months)
Secondary Outcomes (3)
Objective Response Rate (ORR)
From first dose to study completion date (up to approximately 50 months)
Progression Free Survival (PFS)
From first dose to study completion date (up to approximately 50 months)
Overall Survival (OS)
From first dose to study completion date (up to approximately 50 months)
Study Arms (2)
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
EXPERIMENTALpatients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
Elotuzumab + Nivolumab (EN)
EXPERIMENTALPatients will receive treatment with a combination of elotuzumab and nivolumab
Interventions
Eligibility Criteria
You may qualify if:
- All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
- ECOG Performance Status less than or equal to 2
- 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.
- 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.
- 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.
You may not qualify if:
- Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
- 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)
- Subjects with Central Nervous System involvement with multiple myeloma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Southern Cancer Center
Mobile, Alabama, 36607, United States
Sansum Clinic - USOR
Santa Barbara, California, 93105, United States
Colorado Blood Cancer Institute - PPDS
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, 80218, United States
Florida Cancer Specialists - EAST - SCRI - PPDS
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, 33705, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
Bay Hematology Oncology
Easton, Maryland, 21601, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Washington University
St Louis, Missouri, 63110, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Greenville Health System
Greenville, South Carolina, 29615, United States
Avera Health Care
Sioux Falls, South Dakota, 57105, United States
Jones Clinic PC
Germantown, Tennessee, 38138, United States
Tennessee Oncology NASH - SCRI - PPDS
Nashville, Tennessee, 37203, United States
Texas Oncology (Loop) - USOR
San Antonio, Texas, 78217, United States
Virginia Cancer Specialists (Leesburg) - USOR
Leesburg, Virginia, 20176, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Cancer Care Northwest
Spokane Valley, Washington, 99216, United States
Aurora Health Care
Burlington, Wisconsin, 53105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2015
First Posted
November 24, 2015
Study Start
February 9, 2016
Primary Completion
July 29, 2019
Study Completion
June 12, 2020
Last Updated
July 2, 2021
Results First Posted
August 6, 2020
Record last verified: 2021-06