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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719613
Recruitment Status : Active, not recruiting
First Posted : March 25, 2016
Last Update Posted : March 29, 2023
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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 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 : December 20, 2023
Estimated Study Completion Date : December 20, 2023

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 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 ®




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. ]


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 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


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
Show Show 40 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023
Additional relevant MeSH terms:
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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