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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02252263
First Posted: September 30, 2014
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Drug: Elotuzumab Drug: Lirilumab Drug: Urelumab Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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 [ Time Frame: During treatment and first 100 days after treatment ]
    adverse events (AEs), serious adverse events (SAEs)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Actual Study Start Date: December 9, 2014
Study Completion Date: October 10, 2017
Primary Completion Date: October 10, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Drug: Elotuzumab
Other Name: BMS-901608
Drug: Urelumab
Other Name: BMS-663513

Detailed Description:

Allocation:

  • Part1: Non-randomized
  • Part2: Randomized
  Eligibility

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02252263     History of Changes
Other Study ID Numbers: CA223-028
First Submitted: September 26, 2014
First Posted: September 30, 2014
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

Additional relevant MeSH terms:
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