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

NCT02719613 | Completed Phase 2

• 2 other identifiers: CA204-1852016-000037-51
• Study Type: interventional
• Target: 67
• Locations: 13 countries
• Sites: 41

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (1)

Elotuzumab

EXPERIMENTAL

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; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Bortezomib; Drug: Pomalidomide; Drug: Nivolumab

Interventions

Elotuzumab DRUG

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.

Also known as: BMS-901608, HuLuc63, Empliciti

Elotuzumab

Dexamethasone DRUG

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.

Elotuzumab

Lenalidomide DRUG

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.

Also known as: Revlimid®

Elotuzumab

Bortezomib DRUG

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.

Also known as: Velcade®

Elotuzumab

Pomalidomide DRUG

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.

Also known as: Pomalyst ®

Elotuzumab

Nivolumab DRUG

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.

Also known as: Opdivo ®

Elotuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• AbbVie: collaborator

Study Sites (41)

Local Institution - 0020

Tucson, Arizona, 85715, United States

Location

Local Institution - 0017

Bakersfield, California, 93309, United States

Location

Local Institution - 0022

Fountain Valley, California, 92708, United States

Location

Local Institution - 0016

West Hollywood, California, 90069, United States

Location

Local Institution - 0019

Denver, Colorado, 80218, United States

Location

Local Institution - 0021

Jacksonville, Florida, 32256, United States

Location

Local Institution - 0042

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0009

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0003

Indianapolis, Indiana, 46260, United States

Location

Local Institution - 0002

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0008

St Louis, Missouri, 63110, United States

Location

Local Institution - 0004

New York, New York, 10029, United States

Location

Local Institution - 0001

Bethlehem, Pennsylvania, 18015, United States

Location

Local Institution - 0018

Dallas, Texas, 75231, United States

Location

Local Institution - 0034

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0023

Antwerp, 2060, Belgium

Location

Local Institution - 0011

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0010

Halifax, B3H 2Y9, Canada

Location

Local Institution - 0035

Athens, 11528, Greece

Location

Local Institution - 0036

Budapest, 1097, Hungary

Location

Local Institution - 0015

Ancona, 60126, Italy

Location

Local Institution - 0012

Florence, 50134, Italy

Location

Local Institution - 0013

Genova, 16132, Italy

Location

Local Institution - 0043

Ravenna, 48121, Italy

Location

Local Institution - 0044

Terni, 05100, Italy

Location

Local Institution - 0014

Torino, 10126, Italy

Location

Local Institution - 0046

Aomori, Aomori, 0308553, Japan

Location

Local Institution - 0047

Shibukawa-shi, Gunma, 3770280, Japan

Location

Local Institution - 0049

Osaka, Osaka, 5300012, Japan

Location

Local Institution - 0048

Koto-ku, Tokyo, 135-8550, Japan

Location

Local Institution - 0050

Chiba, 260-8677, Japan

Location

Local Institution - 0045

Kasama-shi, 3091793, Japan

Location

Local Institution - 0027

Chorzów, 41-500, Poland

Location

Local Institution - 0026

Warsaw, 02-106, Poland

Location

Local Institution - 0039

Warsaw, 02-776, Poland

Location

Local Institution - 0028

Bucharest, 030171, Romania

Location

Local Institution - 0029

Iași, 700483, Romania

Location

Local Institution - 0041

Barcelona, 08036, Spain

Location

Local Institution - 0030

Toledo, 45004, Spain

Location

Local Institution - 0031

Cebeci Ankara, 06620, Turkey (Türkiye)

Location

Local Institution - 0032

London, EC1A 7BE, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma

Interventions

elotuzumab; Dexamethasone; Lenalidomide; Bortezomib; pomalidomide; Nivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 25, 2016
• Study Start: July 15, 2016
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

BE (1); RO (2); ES (2); GB (1); AU (1); HU (1); CA (2); JP (6); PL (3); US (14); TU (1); GR (1); IT (6)