Multiple Myeloma
Conditions
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.
Interventions
DRUGElotuzumab
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.
DRUGDexamethasone
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.
DRUGLenalidomide
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.
DRUGBortezomib
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.
DRUGPomalidomide
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.
DRUGNivolumab
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.
Sponsors
Bristol-Myers Squibb
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
Australia, Belgium, Canada, Greece, Hungary, Italy, Japan, Poland, Romania, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed