Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab

Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab

The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elotuzumab; Drug: Dexamethasone; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Bortezomib; Drug: Pomalidomide; Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Local Institution - 0034
• Belgium
  • Antwerp, Belgium, 2060
    • Local Institution - 0023
• Canada
  • Halifax, Canada, B3H 2Y9
    • Local Institution - 0010
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0011
• Greece
  • Athens, Greece, 11528
    • Local Institution - 0035
• Hungary
  • Budapest, Hungary, 1097
    • Local Institution - 0036
• Italy
  • Ancona, Italy, 60126
    • Local Institution - 0015
  • Florence, Italy, 50134
    • Local Institution - 0012
  • Genova, Italy, 16132
    • Local Institution - 0013
  • Ravenna, Italy, 48121
    • Local Institution - 0043
  • Terni, Italy, 05100
    • Local Institution - 0044
  • Torino, Italy, 10126
    • Local Institution - 0014
• Japan
  • Chiba, Japan, 260-8677
    • Local Institution - 0050
  • Kasama-shi, Japan, 3091793
    • Local Institution - 0045
  • Aomori
    • Aomori, Aomori, Japan, 0308553
      • Local Institution - 0046
  • Gunma
    • Shibukawa-shi, Gunma, Japan, 3770280
      • Local Institution - 0047
  • Osaka
    • Osaka, Osaka, Japan, 5300012
      • Local Institution - 0049
  • Tokyo
    • Koto-ku, Tokyo, Japan, 135-8550
      • Local Institution - 0048
• Poland
  • Chorzów, Poland, 41-500
    • Local Institution - 0027
  • Warsaw, Poland, 02-106
    • Local Institution - 0026
  • Warsaw, Poland, 02-776
    • Local Institution - 0039
• Romania
  • Bucharest, Romania, 030171
    • Local Institution - 0028
  • Iași, Romania, 700483
    • Local Institution - 0029
• Spain
  • Barcelona, Spain, 08036
    • Local Institution - 0041
  • Toledo, Spain, 45004
    • Local Institution - 0030
• Turkey (Türkiye)
  • Cebeci Ankara, Turkey (Türkiye), 06620
    • Local Institution - 0031
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Local Institution - 0032
• United States
  • Arizona
    • Tucson, Arizona, United States, 85715
      • Local Institution - 0020
  • California
    • Bakersfield, California, United States, 93309
      • Local Institution - 0017
    • Fountain Valley, California, United States, 92708
      • Local Institution - 0022
    • West Hollywood, California, United States, 90069
      • Local Institution - 0016
  • Colorado
    • Denver, Colorado, United States, 80218
      • Local Institution - 0019
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 0021
    • St. Petersburg, Florida, United States, 33705
      • Local Institution - 0042
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 0009
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Local Institution - 0003
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0002
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Local Institution - 0008
  • New York
    • New York, New York, United States, 10029
      • Local Institution - 0004
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Local Institution - 0001
  • Texas
    • Dallas, Texas, United States, 75231
      • Local Institution - 0018

Participation Criteria

Eligibility Criteria

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

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol
• Receiving elotuzumab and/or other study drugs at the time of signature of informed consent
• Males and Females, ages 18 and older

Exclusion Criteria:

• All participants previously discontinued from an elotuzumab study for any reason
• Participants not receiving clinical benefit from previous study therapy
• Participants who are not medically well enough to receive study therapy as determined by the investigator

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Elotuzumab; This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol.

Drug: Elotuzumab; Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.; Other Names: BMS-901608; Empliciti; HuLuc63; Drug: Dexamethasone; Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study.; Drug: Dexamethasone; Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.; Drug: Lenalidomide; Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.; Other Names: Revlimid®; Drug: Bortezomib; Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study.; Other Names: Velcade®; Drug: Pomalidomide; Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.; Other Names: Pomalyst ®; Drug: Nivolumab; Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.; Other Names: Opdivo ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of participants who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.	Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
All serious adverse events (SAEs) will be collected.	Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All Grade 5 adverse events (AEs) will be collected.	Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All adverse events (AEs) previously not reported will be collected.	Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.
All adverse events (AEs) leading to discontinuation will be collected.	Maximum duration is until all participants have discontinued study drugs, or until all participants are treated for up to 2 years, unless BMS chooses to extend the study.

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: AbbVie
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2016
• Primary Completion (Actual): February 23, 2026
• Study Completion (Actual): February 23, 2026

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimated): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Nivolumab; Bortezomib; Dexamethasone; pomalidomide; elotuzumab
• Other Study ID Numbers: CA204-185; 2016-000037-51 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR