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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Elotuzumab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02719613

CA204-185

2016-000037-51 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Elotuzumab

Experimental group

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.

Treatment:

Drug: Nivolumab

Drug: Bortezomib

Drug: Lenalidomide

Drug: Dexamethasone

Drug: Elotuzumab

Drug: Dexamethasone

Drug: Pomalidomide