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.
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02612779
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
-
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.
- 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
Other protocol defined inclusion/exclusion criteria could apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) Elotuzumab patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) Pomalidomide patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. Elotuzumab + Nivolumab (EN) Elotuzumab Patients will receive treatment with a combination of elotuzumab and nivolumab Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) Dexamethasone patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) Nivolumab patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. Elotuzumab + Nivolumab (EN) Nivolumab Patients will receive treatment with a combination of elotuzumab and nivolumab
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From first dose to study completion date (up to approximately 50 months) 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.Objective Response Rate (ORR) From first dose to study completion date (up to approximately 50 months) 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.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) From first dose to study completion date (up to approximately 50 months) 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.
Progression Free Survival (PFS) From first dose to study completion date (up to approximately 50 months) 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.Overall Survival (OS) From first dose to study completion date (up to approximately 50 months) OS is defined as the time from first dosing date to the date of death from any cause.
Trial Locations
- Locations (22)
Bay Hematology Oncology
🇺🇸Easton, Maryland, United States
Southern Cancer Center
🇺🇸Mobile, Alabama, United States
Virginia Cancer Specialists (Leesburg) - USOR
🇺🇸Leesburg, Virginia, United States
Colorado Blood Cancer Institute - PPDS
🇺🇸Denver, Colorado, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Tennessee Oncology NASH - SCRI - PPDS
🇺🇸Nashville, Tennessee, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Sansum Clinic - USOR
🇺🇸Santa Barbara, California, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists - EAST - SCRI - PPDS
🇺🇸Saint Petersburg, Florida, United States
Rocky Mountain Cancer Centers (Williams) - USOR
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Jones Clinic PC
🇺🇸Germantown, Tennessee, United States
Avera Health Care
🇺🇸Sioux Falls, South Dakota, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Cancer Care Northwest
🇺🇸Spokane Valley, Washington, United States
Texas Oncology (Loop) - USOR
🇺🇸San Antonio, Texas, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Aurora Health Care
🇺🇸Burlington, Wisconsin, United States