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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Southern Cancer Center
Mobile, Alabama, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: From first dose to study completion date (up to approximately 50 months)
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.
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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
...and 12 more locations
Time frame: From first dose to study completion date (up to approximately 50 months)
Overall Survival (OS)
OS is defined as the time from first dosing date to the date of death from any cause.
Time frame: From first dose to study completion date (up to approximately 50 months)