Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 81
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Elotuzumab (Drug)
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.
干预措施: Dexamethasone (Drug)
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.
干预措施: Lenalidomide (Drug)
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.
干预措施: Nivolumab (Drug)
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.
干预措施: Bortezomib (Drug)
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.
干预措施: Pomalidomide (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)