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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Elotuzumab
* Drug: Dexamethasone
* Drug: Dexamethasone
* Drug: Lenalidomide
* Drug: Bortezomib
* Drug: Pomalidomide
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elotuzumab<br>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<br>* 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.<br>* Other names: Empliciti;Drug: Dexamethasone<br>* 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.<br>Drug: Dexamethasone<br>* 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.<br>Drug: Lenalidomide<br>* 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.<br>* Other names: Revlimid®;Drug: Bortezomib<br>* 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.<br>* Other names: Velcade®;Drug: Pomalidomide<br>* 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.<br>* Other names: Pomalyst ®;Drug: Nivolumab<br>* 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.<br>* Other names: Opdivo ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All serious adverse events (SAEs) will be collected. |  | 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. | 
| All Grade 5 adverse events (AEs) will be collected. |  | 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. | 
| All adverse events (AEs) previously not reported will be collected. |  | 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. | 
| All adverse events (AEs) leading to discontinuation will be collected. |  | 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. |