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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000037-51-BE

Enrollment

Registered

2020-05-19

Start date

2020-06-10

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Interventions

Trade Name: Empliciti 400 mg powder for concentrate for solution for infusion Product Name: Elotuzumab Product Code: BMS-901608 Pharmaceutical Form: Powder for concentrate for solution for infusion IN

Eligibility

Sex/Gender

All

Inclusion criteria

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 or local age of majority and older, inclusive. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To monitor the safety and tolerability of elotuzumab;Primary end point(s): The number of subjects who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.;Timepoint(s) of evaluation of this end point: Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To monitor the safety and tolerability of elotuzumab;Primary end point(s): The number of subjects who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.;Timepoint(s) of evaluation of this end point: Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): In this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation will be collected. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE).;Timepoint(s) of evaluation of this end point: Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years	—

Measure

Time frame

Secondary end point(s): In this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation will be collected. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE).;Timepoint(s) of evaluation of this end point: Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years

—

Countries

Belgium, Canada, Greece, Hungary, Italy, Poland, Romania, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 14, 2026