Clinical trial NCT02719613: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2016-03-25
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: All serious adverse events (SAEs) will be collected.
timeFrame: 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.
measure: All Grade 5 adverse events (AEs) will be collected.
timeFrame: 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.
measure: All adverse events (AEs) previously not reported will be collected.
timeFrame: 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.
measure: All adverse events (AEs) leading to discontinuation will be collected.
timeFrame: 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.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0020
state: Arizona
city: Bakersfield
country: United States
facility: Local Institution - 0017
state: California
city: Fountain Valley
country: United States
facility: Local Institution - 0022
state: California
city: West Hollywood
country: United States
facility: Local Institution - 0016
state: California
city: Denver
country: United States
facility: Local Institution - 0019
state: Colorado
city: Jacksonville
country: United States
facility: Local Institution - 0021
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 0042
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0009
state: Georgia
city: Indianapolis
country: United States
facility: Local Institution - 0003
state: Indiana
city: Boston
country: United States
facility: Local Institution - 0002
state: Massachusetts
city: Saint Louis
country: United States
facility: Local Institution - 0008
state: Missouri
city: New York
country: United States
facility: Local Institution - 0004
state: New York
city: Bethlehem
country: United States
facility: Local Institution - 0001
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution - 0018
state: Texas
city: Heidelberg
country: Australia
facility: Local Institution - 0034
state: Victoria
city: Antwerpen
country: Belgium
facility: Local Institution - 0023
city: Toronto
country: Canada
facility: Local Institution - 0011
state: Ontario
city: Halifax
country: Canada
facility: Local Institution - 0010
city: Athens
country: Greece
facility: Local Institution - 0035
city: Budapest
country: Hungary
facility: Local Institution - 0036
city: Ancona
country: Italy
facility: Local Institution - 0015
city: Firenze
country: Italy
facility: Local Institution - 0012
city: Genova
country: Italy
facility: Local Institution - 0013
city: Ravenna
country: Italy
facility: Local Institution - 0043
city: Terni
country: Italy
facility: Local Institution - 0044
city: Torino
country: Italy
facility: Local Institution - 0014
city: Aomori-shi
country: Japan
facility: Local Institution - 0046
state: Aomori
city: Shibukawa-shi
country: Japan
facility: Local Institution - 0047
state: Gunma
city: Osaka-shi
country: Japan
facility: Local Institution - 0049
state: Osaka
city: Koto-ku
country: Japan
facility: Local Institution - 0048
state: Tokyo
city: Chiba
country: Japan
facility: Local Institution - 0050
city: Kasama-shi
country: Japan
facility: Local Institution - 0045
city: Chorzow
country: Poland
facility: Local Institution - 0027
city: Warszawa
country: Poland
facility: Local Institution - 0026
city: Warszawa
country: Poland
facility: Local Institution - 0039
city: Bucuresti
country: Romania
facility: Local Institution - 0028
city: Iasi
country: Romania
facility: Local Institution - 0029
city: Barcelona
country: Spain
facility: Local Institution - 0041
city: Toledo
country: Spain
facility: Local Institution - 0030
city: Cebeci Ankara
country: Turkey
facility: Local Institution - 0031
city: London
country: United Kingdom
facility: Local Institution - 0032
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: