Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02719613
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 67
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Elotuzumab Elotuzumab 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. Elotuzumab Nivolumab 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. Elotuzumab Dexamethasone 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. Elotuzumab Lenalidomide 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. Elotuzumab Bortezomib 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. Elotuzumab Pomalidomide 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (41)
Local Institution - 0009
🇺🇸Atlanta, Georgia, United States
Local Institution - 0002
🇺🇸Boston, Massachusetts, United States
Local Institution - 0048
🇯🇵Koto-ku, Tokyo, Japan
Local Institution - 0021
🇺🇸Jacksonville, Florida, United States
Local Institution - 0017
🇺🇸Bakersfield, California, United States
Local Institution - 0019
🇺🇸Denver, Colorado, United States
Local Institution - 0008
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0035
🇬🇷Athens, Greece
Local Institution - 0013
🇮🇹Genova, Italy
Local Institution - 0044
🇮🇹Terni, Italy
Local Institution - 0014
🇮🇹Torino, Italy
Local Institution - 0026
🇵🇱Warszawa, Poland
Local Institution - 0050
🇯🇵Chiba, Japan
Local Institution - 0031
🇹🇷Cebeci Ankara, Turkey
Local Institution - 0028
🇷🇴Bucuresti, Romania
Local Institution - 0032
🇬🇧London, United Kingdom
Local Institution - 0030
🇪🇸Toledo, Spain
Local Institution - 0041
🇪🇸Barcelona, Spain
Local Institution - 0020
🇺🇸Tucson, Arizona, United States
Local Institution - 0016
🇺🇸West Hollywood, California, United States
Local Institution - 0022
🇺🇸Fountain Valley, California, United States
Local Institution - 0042
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 0003
🇺🇸Indianapolis, Indiana, United States
Local Institution - 0001
🇺🇸Bethlehem, Pennsylvania, United States
Local Institution - 0004
🇺🇸New York, New York, United States
Local Institution - 0018
🇺🇸Dallas, Texas, United States
Local Institution - 0034
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0023
🇧🇪Antwerpen, Belgium
Local Institution - 0011
🇨🇦Toronto, Ontario, Canada
Local Institution - 0015
🇮🇹Ancona, Italy
Local Institution - 0036
🇭🇺Budapest, Hungary
Local Institution - 0010
🇨🇦Halifax, Canada
Local Institution - 0012
🇮🇹Firenze, Italy
Local Institution - 0043
🇮🇹Ravenna, Italy
Local Institution - 0046
🇯🇵Aomori-shi, Aomori, Japan
Local Institution - 0047
🇯🇵Shibukawa-shi, Gunma, Japan
Local Institution - 0049
🇯🇵Osaka-shi, Osaka, Japan
Local Institution - 0027
🇵🇱Chorzow, Poland
Local Institution - 0045
🇯🇵Kasama-shi, Japan
Local Institution - 0029
🇷🇴Iasi, Romania
Local Institution - 0039
🇵🇱Warszawa, Poland