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

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ClinicalTrials.gov Identifier: NCT02719613
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to continue to provide elotuzumab and/or other study drugs to subjects 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 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
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 11, 2016
Estimated Primary Completion Date : May 28, 2020
Estimated Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Elotuzumab

Arm Intervention/treatment
Experimental: Elotuzumab
This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All subjects 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®




Primary Outcome Measures :
  1. The number of subjects who received at least one dose of elotuzumab or backbone therapy (other study drugs) will be collected. [ Time Frame: Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years. ]

Secondary Outcome Measures :
  1. All serious adverse events (SAEs) and adverse events (AEs) will be collected. [ Time Frame: Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years. ]


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

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719613


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Arizona
Arizona Clinical Research Center, Inc Recruiting
Tucson, Arizona, United States, 85715
Contact: Manuel Modiano, Site 0020         
United States, California
Comprehensive Blood And Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Alan Cartmell, Site 0017         
James R. Berenson, MD, Inc. Recruiting
Bakersfield, California, United States, 93309
Contact: James Berenson, Site 0016         
Robert A. Moss, Md Facp, Inc. Recruiting
Fountain Valley, California, United States, 92708
Contact: Robert Moss, Site 0022         
United States, Colorado
Rocky Mountain Cancer Centers (Williams) - USOR Recruiting
Denver, Colorado, United States, 80218
Contact: Robert Rifkin, Site 0019         
United States, Florida
Cancer Specialists of North FL Recruiting
Jacksonville, Florida, United States, 32256
Contact: Suprith Badarinath, Site 0021         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sagar Lonial, Site 0009    404-778-4176      
United States, Indiana
Investigative Clinical Research Of Indiana, Llc Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Robert Manges, Site 0003    317-297-2208      
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Paul Richardson, Site 0002         
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ravi Vij, Site 0008    314-747-7813      
United States, New York
Icahn School Of Medicine At Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Sundar Jagannath, Site 0004    212-241-2592      
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Yacoub Faroun, Site 0001    484-503-4150      
United States, Texas
Texas Oncology Recruiting
Dallas, Texas, United States, 75231
Contact: Kristi McIntyre, Site 0018         
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0011         
Canada
Local Institution Recruiting
Halifax, Canada, B3H 2Y9
Contact: Site 0010         
Italy
Local Institution Recruiting
Ancona, Italy, 60126
Contact: Site 0015         
Local Institution Recruiting
Firenze, Italy, 50134
Contact: Site 0012         
Local Institution Recruiting
Genova, Italy, 16132
Contact: Site 0013         
Local Institution Recruiting
Torino, Italy, 10126
Contact: Site 0014         
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02719613     History of Changes
Other Study ID Numbers: CA204-185
2016-000037-51 ( EudraCT Number )
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

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 acetate
Dexamethasone
Lenalidomide
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents