Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab
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| ClinicalTrials.gov Identifier: NCT02719613 |
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Recruitment Status :
Active, not recruiting
First Posted : March 25, 2016
Last Update Posted : March 29, 2023
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Sponsor:
Bristol-Myers Squibb
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Elotuzumab Drug: Dexamethasone Drug: Lenalidomide Drug: Bortezomib Drug: Pomalidomide Drug: Nivolumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 67 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab |
| Actual Study Start Date : | July 15, 2016 |
| Estimated Primary Completion Date : | December 20, 2023 |
| Estimated Study Completion Date : | December 20, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
Drug Information available for:
Elotuzumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: Elotuzumab
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.
Other Names:
Drug: Dexamethasone 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. Drug: Dexamethasone Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study. Drug: Lenalidomide 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.
Other Name: Revlimid® Drug: Bortezomib 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.
Other Name: Velcade® Drug: Pomalidomide 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.
Other Name: Pomalyst ® Drug: Nivolumab 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.
Other Name: Opdivo ® |
Primary Outcome Measures :
- 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. [ Time Frame: 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 :
- All serious adverse events (SAEs) will be collected. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719613
Locations
Show 40 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02719613 |
| Other Study ID Numbers: |
CA204-185 2016-000037-51 ( EudraCT Number ) |
| First Posted: | March 25, 2016 Key Record Dates |
| Last Update Posted: | March 29, 2023 |
| Last Verified: | March 2023 |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Dexamethasone acetate Nivolumab Lenalidomide Bortezomib Pomalidomide Elotuzumab BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones |