Empliciti® (Elotuzumab) Post-Marketing Surveillance Study for Patients With Multiple Myeloma in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This observational study aimed to assess the safety of elotuzumab when used in combination with pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma (RRMM) in participants who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The study will also assess the safety of elotuzumab when used in combination with lenalidomide and dexamethasone in RRMM participants who had received one to three prior therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Confirmed diagnosis of RRMM
- •Received ≥ 2 prior therapies including lenalidomide and a proteasome inhibitor
- •Planning to receive elotuzumab in combination with pomalidomide and dexamethasone at physician's medical judgement OR
- •Age ≥ 18 years
- •Confirmed diagnosis of RRMM
- •Received one to three prior therapies
- •Planning to receive elotuzumab in combination with lenalidomide and dexamethasone at physician's medical judgement
排除标准
- •Participants with therapeutic indications for which elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone has not been approved in Taiwan
- •Participants who are contraindicated for treated with elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone (as described in the Taiwan label)
- •Participants who participate in other interventional clinical trials
研究组 & 干预措施
Treated with Elotuzumab in combination with pomalidomide and dexamethasone
干预措施: Elotuzumab in combination with pomalidomide and dexamethasone (Drug)
Treated with Elotuzumab in combination with lenalidomide and dexamethasone
干预措施: Elotuzumab in combination with lenalidomide and dexamethasone (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date)
Assessed according to NCI CTCAE v5.0
Number of participants with adverse events of special interest
时间窗: 25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date)
Opportunistic infections including viral hepatitis and tuberculosis reactivation
次要结局
- Number of participants with fungal infections(25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date))
- Number of participants with reactivation of viral hepatitis(25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date))
- Number of participants with other viral infection/reactivation(25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date))
- Number of participants with tuberculosis infection/reactivation(25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date))
- Number of participants with other opportunistic infections(25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date))
- Number of participants with lymphopenia(25 weeks from start of treatment, or during a 30-day follow-up period following treatment discontinuation (whichever time period falls at a later date))