Multiple Myeloma
Conditions
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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Objective Response rate (ORR) | At different timepoints approximately up to 2.5 years |
| Median Duration of Response (mDOR) | 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 |
| M-protein levels | 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 |
| Maximum concentration of Urelumab (Cmax) | At different timepoints approximately up to 2.5 years |
| Maximum concentration of Lirilumab (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 |
| Best Overall Response (BOR) | At different timepoints approximately up to 2.5 years |
| Volume of distribution (Vz) for Urelumab | 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 |
| Concentration at the end of infusion (ceoinf) of 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 |
| Concentration at the end of infusion (ceoinf) of Lirilumab | 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 |
| 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 |
| Area under the Curve (AUCTAU) of Lirilumab | At different timepoints approximately up to 2.5 years |
Countries
Spain, United States
Outcome results
None listed