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
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ClinicalTrials.gov Identifier: NCT02252263 |
Recruitment Status :
Completed
First Posted : September 30, 2014
Last Update Posted : November 1, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Elotuzumab Drug: Lirilumab Drug: Urelumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 9, 2014 |
Actual Primary Completion Date : | October 10, 2017 |
Actual Study Completion Date : | October 10, 2017 |

Arm | Intervention/treatment |
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Experimental: 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
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Drug: Elotuzumab
Other Name: BMS-901608 Drug: Lirilumab Other Name: BMS-986015 |
Experimental: 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
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Drug: Elotuzumab
Other Name: BMS-901608 Drug: Urelumab Other Name: BMS-663513 |
- 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 [ Time Frame: During treatment and first 100 days after treatment ]adverse events (AEs), serious adverse events (SAEs)
- Best Overall Response (BOR) [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Objective Response rate (ORR) [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Median Duration of Response (mDOR) [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Median Time to Response (mTTR) [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Progression-free survival rate (PFSR) [ Time Frame: At different timepoints approximately up to 2.5 years ]
- M-protein levels [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Maximum concentration of Urelumab (Cmax) [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Maximum concentration of Lirilumab (Cmax) [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Area under the Curve (AUCTAU) of Urelumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Area under the Curve (AUCTAU) of Lirilumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Volume of distribution (Vz) for Urelumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Total Clearance (CLT) of Urelumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Total Clearance (CLT) of Lirilumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Concentration at the end of infusion (ceoinf) of Urelumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Concentration at the end of infusion (ceoinf) of Elotuzumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Concentration at the end of infusion (ceoinf) of Lirilumab [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Cmin will be capture at steady state of all study subjects [ Time Frame: At different timepoints approximately up to 2.5 years ]
- Occurence of Specific anti-drug antibodies (ADA) to each study drug [ Time Frame: At different timepoints approximately up to 2.5 years ]
- ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects [ Time Frame: At different timepoints approximately up to 2.5 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252263
United States, Arkansas | |
University Of Arkansas For Medical Sciences | |
Little Rock, Arkansas, United States | |
United States, Maryland | |
The Sidney Kimmel Comprehensive Cancer Center | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
University Of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Spain | |
Local Institution | |
Pamplona, Navarra, Spain, 31008 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02252263 |
Other Study ID Numbers: |
CA223-028 |
First Posted: | September 30, 2014 Key Record Dates |
Last Update Posted: | November 1, 2017 |
Last Verified: | October 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Elotuzumab Antineoplastic Agents |