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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252263
• Other study ID #: CA223-028
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2014
• Last updated: October 30, 2017
• Start date: December 9, 2014
• Est. completion date: October 10, 2017

Study information

• Verified date: October 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Allocation:

• Part1: Non-randomized

• Part2: Randomized

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elotuzumab

• Lirilumab

• Urelumab

Locations

Country	Name	City	State
Spain	Local Institution	Pamplona	Navarra
United States	The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	The Ohio State University	Columbus	Ohio
United States	University Of Arkansas For Medical Sciences	Little Rock	Arkansas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adverse events (AEs), serious adverse events (SAEs)	During treatment and first 100 days after treatment
Secondary	Best Overall Response (BOR)		At different timepoints approximately up to 2.5 years
Secondary	Objective Response rate (ORR)		At different timepoints approximately up to 2.5 years
Secondary	Median Duration of Response (mDOR)		At different timepoints approximately up to 2.5 years
Secondary	Median Time to Response (mTTR)		At different timepoints approximately up to 2.5 years
Secondary	Progression-free survival rate (PFSR)		At different timepoints approximately up to 2.5 years
Secondary	M-protein levels		At different timepoints approximately up to 2.5 years
Secondary	Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects		At different timepoints approximately up to 2.5 years
Secondary	Maximum concentration of Urelumab (Cmax)		At different timepoints approximately up to 2.5 years
Secondary	Maximum concentration of Lirilumab (Cmax)		At different timepoints approximately up to 2.5 years
Secondary	Area under the Curve (AUCTAU) of Urelumab		At different timepoints approximately up to 2.5 years
Secondary	Area under the Curve (AUCTAU) of Lirilumab		At different timepoints approximately up to 2.5 years
Secondary	Volume of distribution (Vz) for Urelumab		At different timepoints approximately up to 2.5 years
Secondary	Total Clearance (CLT) of Urelumab		At different timepoints approximately up to 2.5 years
Secondary	Total Clearance (CLT) of Lirilumab		At different timepoints approximately up to 2.5 years
Secondary	Concentration at the end of infusion (ceoinf) of Urelumab		At different timepoints approximately up to 2.5 years
Secondary	Concentration at the end of infusion (ceoinf) of Elotuzumab		At different timepoints approximately up to 2.5 years
Secondary	Concentration at the end of infusion (ceoinf) of Lirilumab		At different timepoints approximately up to 2.5 years
Secondary	Cmin will be capture at steady state of all study subjects		At different timepoints approximately up to 2.5 years
Secondary	Occurence of Specific anti-drug antibodies (ADA) to each study drug		At different timepoints approximately up to 2.5 years
Secondary	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

External Links

•   BMS Clinical Trial Information
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