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

• ClinicalTrials.gov Identifier: NCT02719613
• Recruitment Status: Active, not recruiting
• First Posted: March 25, 2016
• Last Update Posted: May 28, 2020
• Sponsor: Bristol-Myers Squibb
• Collaborator: AbbVie
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Elotuzumab; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Bortezomib; Drug: Pomalidomide; Drug: Nivolumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab
• Actual Study Start Date: July 15, 2016
• Estimated Primary Completion Date: July 30, 2020
• Estimated Study Completion Date: July 31, 2020

Arms and Interventions

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; HuLuc63; Empliciti; 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 Name: 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 Name: 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 Name: 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 Name: Opdivo ®

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: 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 :

1. All serious adverse events (SAEs) will be collected. [ Time Frame: 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. ]
2. All Grade 5 adverse events (AEs) will be collected. [ Time Frame: 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. ]
3. All adverse events (AEs) previously not reported will be collected. [ Time Frame: 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. ]
4. All adverse events (AEs) leading to discontinuation will be collected. [ Time Frame: 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. ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Arizona Clinical Research Center, Inc

Tucson, Arizona, United States, 85715

United States, California

Comprehensive Blood And Cancer Center

Bakersfield, California, United States, 93309

James R. Berenson, MD, Inc.

Bakersfield, California, United States, 93309

Robert A. Moss, Md Facp, Inc.

Fountain Valley, California, United States, 92708

United States, Colorado

Rocky Mountain Cancer Centers (Williams) - USOR

Denver, Colorado, United States, 80218

United States, Florida

Cancer Specialists of North FL

Jacksonville, Florida, United States, 32256

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Indiana

Investigative Clinical Research Of Indiana, Llc

Indianapolis, Indiana, United States, 46260

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Missouri

Washington University School Of Medicine

Saint Louis, Missouri, United States, 63110

United States, New York

Icahn School Of Medicine At Mount Sinai

New York, New York, United States, 10029

United States, Pennsylvania

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States, 18015

United States, Texas

Texas Oncology

Dallas, Texas, United States, 75231

Canada, Ontario

Local Institution

Toronto, Ontario, Canada, M5G 2M9

Canada

Local Institution

Halifax, Canada, B3H 2Y9

Italy

Local Institution

Ancona, Italy, 60126

Local Institution

Firenze, Italy, 50134

Local Institution

Genova, Italy, 16132

Local Institution

Torino, Italy, 10126

Sponsors and Collaborators

Bristol-Myers Squibb

AbbVie

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

FDA Safety Alerts and Recalls 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02719613
• Other Study ID Numbers: CA204-185; 2016-000037-51 ( EudraCT Number )
• First Posted: March 25, 2016
• Last Update Posted: May 28, 2020
• Last Verified: May 2020

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; Dexamethasone; Dexamethasone acetate; Nivolumab; Lenalidomide; Bortezomib; Pomalidomide; Elotuzumab; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones