A Phase I Open Label Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma
Phase 1
Completed
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02252263
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.
- Detailed Description
Allocation:
* Part1: Non-randomized
* Part2: Randomized
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
-
Subjects must have histological confirmation of multiple myeloma with measurable disease (per International Myeloma Working Group (IMWG) criteria):
- Relapsed/refractory multiple myeloma, subjects who are post autologous transplant and have achieved very good partial response (VGPR) or complete response (nCR) with minimal residual disease (MRD)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Elotuzumab + Lirilumab Elotuzumab Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response Arm 2: Elotuzumab + Urelumab Elotuzumab Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response Arm 2: Elotuzumab + Urelumab Urelumab Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response Arm 1: Elotuzumab + Lirilumab Lirilumab Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response
- Primary Outcome Measures
Name Time Method Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety During treatment and first 100 days after treatment adverse events (AEs), serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method M-protein levels At different timepoints approximately up to 2.5 years Maximum concentration of Lirilumab (Cmax) At different timepoints approximately up to 2.5 years Total Clearance (CLT) of Urelumab At different timepoints approximately up to 2.5 years Total Clearance (CLT) of Lirilumab At different timepoints approximately up to 2.5 years Maximum concentration of Urelumab (Cmax) At different timepoints approximately up to 2.5 years Area under the Curve (AUCTAU) of Urelumab At different timepoints approximately up to 2.5 years Volume of distribution (Vz) for Urelumab At different timepoints approximately up to 2.5 years Concentration at the end of infusion (ceoinf) of Elotuzumab At different timepoints approximately up to 2.5 years Occurence of Specific anti-drug antibodies (ADA) to each study drug At different timepoints approximately up to 2.5 years ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects At different timepoints approximately up to 2.5 years Median Duration of Response (mDOR) At different timepoints approximately up to 2.5 years Concentration at the end of infusion (ceoinf) of Urelumab At different timepoints approximately up to 2.5 years Objective Response rate (ORR) At different timepoints approximately up to 2.5 years Area under the Curve (AUCTAU) of Lirilumab At different timepoints approximately up to 2.5 years Concentration at the end of infusion (ceoinf) of Lirilumab At different timepoints approximately up to 2.5 years Best Overall Response (BOR) At different timepoints approximately up to 2.5 years Median Time to Response (mTTR) At different timepoints approximately up to 2.5 years Progression-free survival rate (PFSR) At different timepoints approximately up to 2.5 years Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects At different timepoints approximately up to 2.5 years Cmin will be capture at steady state of all study subjects At different timepoints approximately up to 2.5 years
Trial Locations
- Locations (7)
Local Institution
🇪🇸Pamplona, Navarra, Spain
The Ohio State University
🇺🇸Columbus, Ohio, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
University Of Arkansas For Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States