A Phase 2 Single Arm Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 29
- 主要终点
- Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
研究概览
简要总结
To explore whether Elotuzumab dose administration over approximately 60 minutes is feasible and safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Documented evidence of active multiple myeloma:
- •Newly diagnosed, not candidate for transplant
- •Relapsed/refractory who have received up to 3 prior lines of therapy
- •Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:
- •Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
- •Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)
排除标准
- •Target Disease Exceptions
- •Plasma cell leukemia
- •Monoclonal gammopathy of undetermined significance (MGUS)
- •Smoldering Myeloma
- •Primary amyloidosis
- •Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
研究组 & 干预措施
Elotuzumab + Lenalidomide/Dexamethasone
Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
干预措施: Elotuzumab (Drug)
Elotuzumab + Lenalidomide/Dexamethasone
Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
干预措施: Lenalidomide (Drug)
Elotuzumab + Lenalidomide/Dexamethasone
Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
时间窗: From Day 1 to End of cycle 2 treatment (approximately 56 days)
Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
次要结局
- Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period(Date of first dose up to 60 days post last dose (approximately 4 years))