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
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Elotuzumab Type: Drug
Name: Lirilumab Type: Drug
Name: Urelumab Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)
Locations
Local Institution
Little Rock, Arkansas, United States
Status: Not yet recruiting
Contact: Site 0007
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Ivan Borrello, Site 0005 - 410-955-4967
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Alexander Lesokhin, Site 0001 - 212-639-3069
The Ohio State University
Columbus, Ohio, United States
Status: Recruiting
Contact: Don Benson, Site 0002 - 614-293-8605
Oregon Health & Science University
Portland, Oregon, United States
Status: Recruiting
Contact: Emma Scott, Site 0003 - 503-494-1453
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Adam Cohen, Site 0004 - 215-615-5853
Start Date
December 2014
Completion Date
April 2017
Sponsors
Bristol-Myers Squibb
Source
Bristol-Myers Squibb
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page