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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elotuzumab; Drug: Urelumab; Drug: Lirilumab

Detailed Description

Allocation:

• Part1: Non-randomized
• Part2: Randomized

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Local Institution
• United States
  • Arkansas
    • Little Rock, Arkansas, United States
      • University of Arkansas for Medical Sciences
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Sidney Kimmel Comprehensive Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: BMS-901608; Drug: Lirilumab; Other Names: 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 Names: BMS-901608; Drug: Urelumab; Other Names: BMS-663513

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	During treatment and first 100 days after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Best Overall Response (BOR)	At different timepoints approximately up to 2.5 years
Objective Response rate (ORR)	At different timepoints approximately up to 2.5 years
Median Duration of Response (mDOR)	At different timepoints approximately up to 2.5 years
Median Time to Response (mTTR)	At different timepoints approximately up to 2.5 years
Progression-free survival rate (PFSR)	At different timepoints approximately up to 2.5 years
M-protein levels	At different timepoints approximately up to 2.5 years
Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects	At different timepoints approximately up to 2.5 years
Maximum concentration of Urelumab (Cmax)	At different timepoints approximately up to 2.5 years
Maximum concentration of Lirilumab (Cmax)	At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Urelumab	At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Lirilumab	At different timepoints approximately up to 2.5 years
Volume of distribution (Vz) for Urelumab	At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Urelumab	At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Lirilumab	At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Urelumab	At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Elotuzumab	At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Lirilumab	At different timepoints approximately up to 2.5 years
Cmin will be capture at steady state of all study subjects	At different timepoints approximately up to 2.5 years
Occurence of Specific anti-drug antibodies (ADA) to each study drug	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	At different timepoints approximately up to 2.5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2014
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Elotuzumab
• Other Study ID Numbers: CA223-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No