Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments elotuzumab, lirilumab, urelumab
Phase phase 1
Targets SLAMF7, CD137, KIR
Sponsor Bristol-Myers Squibb
Start date December 2014
End date April 2017
Trial size 136 participants
Trial identifier NCT02252263, CA223-028

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response
elotuzumab BMS-901608
lirilumab BMS-986015
(Experimental)
Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response
elotuzumab BMS-901608
urelumab BMS-663513

Primary Outcomes

Measure
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
time frame: During treatment and first 100 days after treatment

Secondary Outcomes

Measure
Best Overall Response (BOR)
time frame: At different timepoints approximately up to 2.5 years
Objective Response rate (ORR)
time frame: At different timepoints approximately up to 2.5 years
Median Duration of Response (mDOR)
time frame: At different timepoints approximately up to 2.5 years
Median Time to Response (mTTR)
time frame: At different timepoints approximately up to 2.5 years
Progression-free survival rate (PFSR)
time frame: At different timepoints approximately up to 2.5 years
M-protein levels
time frame: At different timepoints approximately up to 2.5 years
Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects
time frame: At different timepoints approximately up to 2.5 years
Maximum concentration of Urelumab (Cmax)
time frame: At different timepoints approximately up to 2.5 years
Maximum concentration of Lirilumab (Cmax)
time frame: At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Urelumab
time frame: At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Lirilumab
time frame: At different timepoints approximately up to 2.5 years
Volume of distribution (Vz) for Urelumab
time frame: At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Urelumab
time frame: At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Lirilumab
time frame: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Urelumab
time frame: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Elotuzumab
time frame: At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Lirilumab
time frame: At different timepoints approximately up to 2.5 years
Cmin will be capture at steady state of all study subjects
time frame: At different timepoints approximately up to 2.5 years
Occurence of Specific anti-drug antibodies (ADA) to each study drug
time frame: 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
time frame: At different timepoints approximately up to 2.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title A Phase I Open Label Dose Escalation and Randomized Cohort Expansion 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
Description Allocation: - Part1: Non-randomized - Part2: Randomized
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.
Location data was received from the National Cancer Institute and was last updated in April 2016.