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

NCT ID: NCT02252263

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-09

Study Completion Date

2017-10-10

Brief Summary

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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

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Allocation:

* Part1: Non-randomized
* Part2: Randomized

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Elotuzumab + Lirilumab

Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response

Group Type EXPERIMENTAL

Elotuzumab

Intervention Type DRUG

Lirilumab

Intervention Type DRUG

Arm 2: Elotuzumab + Urelumab

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

Group Type EXPERIMENTAL

Elotuzumab

Intervention Type DRUG

Urelumab

Intervention Type DRUG

Interventions

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Elotuzumab

Intervention Type DRUG

Lirilumab

Intervention Type DRUG

Urelumab

Intervention Type DRUG

Other Intervention Names

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BMS-901608 BMS-986015 BMS-663513

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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University Of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Site Status

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Local Institution

Pamplona, Navarre, Spain

Site Status

Countries

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United States Spain

Related Links

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Other Identifiers

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CA223-028

Identifier Type: -

Identifier Source: org_study_id