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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 : Active, not recruiting
First Posted : March 25, 2016
Last Update Posted : January 14, 2019
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. ]


Information from the National Library of Medicine

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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


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

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: January 14, 2019
Last Verified: January 2019

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