Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 646
- 试验地点
- 39
- 主要终点
- Median Progression Free Survival (PFS)
研究概览
简要总结
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Documented progression from most recent line of therapy
- •1-3 prior lines of therapy
- •Measurable disease
- •Life expectancy ≥3 months
- •Prior treatment with Lenalidomide permitted if:
- •Best response achieved was ≥Partial Response (PR)
- •Patient was not refractory
- •Patient did not discontinue due to a Grade ≥3 related adverse event
- •Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
排除标准
- •Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
- •Active plasma cell leukemia
- •Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
研究组 & 干预措施
Lenalidomide + Dexamethasone
干预措施: Lenalidomide (Drug)
Lenalidomide + Dexamethasone
干预措施: Dexamethasone (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
干预措施: Lenalidomide (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
干预措施: Dexamethasone (Oral) (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
干预措施: Dexamethasone (IV) (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
干预措施: Elotuzumab (BMS-901608; HuLuc63) (Biological)
结局指标
主要结局
Median Progression Free Survival (PFS)
时间窗: From randomization up to 326 events (up to approximately 38 months)
Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
Objective Response Rate (ORR)
时间窗: From randomization up to approximately 38 months
Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR \[sCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
次要结局
- Change From Baseline of Mean Score Pain Severity (BPI-SF)(From baseline up to approximately 38 months)
- Change From Baseline of Mean Score Pain Interference (BPI-SF)(From baseline up to approximately 38 months)
- Median Overall Survival (OS)(Randomization to the date of death from any cause (up to approximately 9 years))