Clinical trial NCT02252263: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-09-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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)

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
timeFrame: During treatment and first 100 days after treatment
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: At different timepoints approximately up to 2.5 years
measure: Objective Response rate (ORR)
timeFrame: At different timepoints approximately up to 2.5 years
measure: Median Duration of Response (mDOR)
timeFrame: At different timepoints approximately up to 2.5 years
measure: Median Time to Response (mTTR)
timeFrame: At different timepoints approximately up to 2.5 years
measure: Progression-free survival rate (PFSR)
timeFrame: At different timepoints approximately up to 2.5 years
measure: M-protein levels
timeFrame: At different timepoints approximately up to 2.5 years
measure: Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects
timeFrame: At different timepoints approximately up to 2.5 years
measure: Maximum concentration of Urelumab (Cmax)
timeFrame: At different timepoints approximately up to 2.5 years
measure: Maximum concentration of Lirilumab (Cmax)
timeFrame: At different timepoints approximately up to 2.5 years
measure: Area under the Curve (AUCTAU) of Urelumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Area under the Curve (AUCTAU) of Lirilumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Volume of distribution (Vz) for Urelumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Total Clearance (CLT) of Urelumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Total Clearance (CLT) of Lirilumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Concentration at the end of infusion (ceoinf) of Urelumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Concentration at the end of infusion (ceoinf) of Elotuzumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Concentration at the end of infusion (ceoinf) of Lirilumab
timeFrame: At different timepoints approximately up to 2.5 years
measure: Cmin will be capture at steady state of all study subjects
timeFrame: At different timepoints approximately up to 2.5 years
measure: Occurence of Specific anti-drug antibodies (ADA) to each study drug
timeFrame: At different timepoints approximately up to 2.5 years
measure: ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects
timeFrame: At different timepoints approximately up to 2.5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University Of Arkansas For Medical Sciences
state: Arkansas
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Pamplona
country: Spain
facility: Local Institution
state: Navarra
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: