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

NCT ID: NCT02719613

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-15

Study Completion Date

2025-11-13

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Elotuzumab

Intervention Type 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.

Dexamethasone

Intervention Type 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.

Dexamethasone

Intervention Type DRUG

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.

Lenalidomide

Intervention Type 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.

Bortezomib

Intervention Type 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.

Pomalidomide

Intervention Type 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.

Nivolumab

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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BMS-901608 HuLuc63 Empliciti Revlimid® Velcade® Pomalyst ® Opdivo ®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0020

Tucson, Arizona, United States

Site Status

Local Institution - 0017

Bakersfield, California, United States

Site Status

Local Institution - 0022

Fountain Valley, California, United States

Site Status

Local Institution - 0016

West Hollywood, California, United States

Site Status

Local Institution - 0019

Denver, Colorado, United States

Site Status

Local Institution - 0021

Jacksonville, Florida, United States

Site Status

Local Institution - 0042

St. Petersburg, Florida, United States

Site Status

Local Institution - 0009

Atlanta, Georgia, United States

Site Status

Local Institution - 0003

Indianapolis, Indiana, United States

Site Status

Local Institution - 0002

Boston, Massachusetts, United States

Site Status

Local Institution - 0008

St Louis, Missouri, United States

Site Status

Local Institution - 0004

New York, New York, United States

Site Status

Local Institution - 0001

Bethlehem, Pennsylvania, United States

Site Status

Local Institution - 0018

Dallas, Texas, United States

Site Status

Local Institution - 0034

Heidelberg, Victoria, Australia

Site Status

Local Institution - 0023

Antwerp, , Belgium

Site Status

Local Institution - 0011

Toronto, Ontario, Canada

Site Status

Local Institution - 0010

Halifax, , Canada

Site Status

Local Institution - 0035

Athens, , Greece

Site Status

Local Institution - 0036

Budapest, , Hungary

Site Status

Local Institution - 0015

Ancona, , Italy

Site Status

Local Institution - 0012

Florence, , Italy

Site Status

Local Institution - 0013

Genova, , Italy

Site Status

Local Institution - 0043

Ravenna, , Italy

Site Status

Local Institution - 0044

Terni, , Italy

Site Status

Local Institution - 0014

Torino, , Italy

Site Status

Local Institution - 0046

Aomori, Aomori, Japan

Site Status

Local Institution - 0047

Shibukawa-shi, Gunma, Japan

Site Status

Local Institution - 0049

Osaka, Osaka, Japan

Site Status

Local Institution - 0048

Koto-ku, Tokyo, Japan

Site Status

Local Institution - 0050

Chiba, , Japan

Site Status

Local Institution - 0045

Kasama-shi, , Japan

Site Status

Local Institution - 0027

Chorzów, , Poland

Site Status

Local Institution - 0026

Warsaw, , Poland

Site Status

Local Institution - 0039

Warsaw, , Poland

Site Status

Local Institution - 0028

Bucharest, , Romania

Site Status

Local Institution - 0029

Iași, , Romania

Site Status

Local Institution - 0041

Barcelona, , Spain

Site Status

Local Institution - 0030

Toledo, , Spain

Site Status

Local Institution - 0031

Cebeci Ankara, , Turkey (Türkiye)

Site Status

Local Institution - 0032

London, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada Greece Hungary Italy Japan Poland Romania Spain Turkey (Türkiye) United Kingdom

Related Links

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Other Identifiers

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2016-000037-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA204-185

Identifier Type: -

Identifier Source: org_study_id

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