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

Primary Purpose

Multiple Myeloma

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Elotuzumab

Dexamethasone

Lenalidomide

Bortezomib

Pomalidomide

Nivolumab

About this trial

This is an interventional supportive care trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elotuzumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All serious adverse events (SAEs) will be collected.

All Grade 5 adverse events (AEs) will be collected.

All adverse events (AEs) previously not reported will be collected.

All adverse events (AEs) leading to discontinuation will be collected.

Full Information

NCT ID

NCT02719613

First Posted

March 16, 2016

Last Updated

September 14, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02719613

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 15, 2016 (Actual)

Primary Completion Date

December 20, 2023 (Anticipated)

Study Completion Date

December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elotuzumab

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Elotuzumab

Other Intervention Name(s)

BMS-901608, HuLuc63, Empliciti

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

Revlimid®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

Velcade®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pomalidomide

Other Intervention Name(s)

Pomalyst ®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo ®

Intervention Description

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.

Primary Outcome Measure Information:

Title

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