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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02719613
First received: March 16, 2016
Last updated: June 9, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Multiple Myeloma Drug: Elotuzumab Drug: Dexamethasone Drug: Lenalidomide Drug: Bortezomib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Supportive Care
Official Title: Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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. ]

Estimated Enrollment: 21
Actual Study Start Date: July 11, 2016
Estimated Study Completion Date: April 30, 2019
Estimated Primary Completion Date: April 29, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 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      
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
  More Information

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 )
Study First Received: March 16, 2016
Last Updated: June 9, 2017

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
Dexamethasone 21-phosphate
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

ClinicalTrials.gov processed this record on June 22, 2017