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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

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Elotuzumab

Lirilumab

Urelumab

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University Of Arkansas For Medical Sciences
The Sidney Kimmel Comprehensive Cancer Center
Memorial Sloan Kettering Cancer Center
The Ohio State University
Oregon Health & Science University
University Of Pennsylvania
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1: Elotuzumab + Lirilumab

Arm 2: Elotuzumab + Urelumab

Arm Description

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 weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Best Overall Response (BOR)

Objective Response rate (ORR)

Median Duration of Response (mDOR)

Median Time to Response (mTTR)

Progression-free survival rate (PFSR)

M-protein levels

Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects

Maximum concentration of Urelumab (Cmax)

Maximum concentration of Lirilumab (Cmax)

Area under the Curve (AUCTAU) of Urelumab

Area under the Curve (AUCTAU) of Lirilumab

Volume of distribution (Vz) for Urelumab

Total Clearance (CLT) of Urelumab

Total Clearance (CLT) of Lirilumab

Concentration at the end of infusion (ceoinf) of Urelumab

Concentration at the end of infusion (ceoinf) of Elotuzumab

Concentration at the end of infusion (ceoinf) of Lirilumab

Cmin will be capture at steady state of all study subjects

Occurence of Specific anti-drug antibodies (ADA) to each study drug

ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects

Full Information

NCT ID

NCT02252263

First Posted

September 26, 2014

Last Updated

October 30, 2017

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02252263

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

December 9, 2014 (Actual)

Primary Completion Date

October 10, 2017 (Actual)

Study Completion Date

October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Elotuzumab + Lirilumab

Arm Type

Experimental

Arm Description

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 Title

Arm 2: Elotuzumab + Urelumab

Arm Type

Experimental

Arm Description

Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response

Intervention Type

Drug

Intervention Name(s)

Elotuzumab

Other Intervention Name(s)

BMS-901608

Intervention Type

Drug

Intervention Name(s)

Lirilumab

Other Intervention Name(s)

BMS-986015

Intervention Type

Drug

Intervention Name(s)

Urelumab

Other Intervention Name(s)

BMS-663513

Primary Outcome Measure Information:

Title

Description

adverse events (AEs), serious adverse events (SAEs)

Time Frame

During treatment and first 100 days after treatment

Secondary Outcome Measure Information:

Title

Best Overall Response (BOR)

Time Frame