A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 748
- 试验地点
- 235
- 主要终点
- 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
- •Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- •have not received any prior systemic anti-myeloma therapy AND
- •have measurable disease AND
- •are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
排除标准
- •Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
- •Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
- •Monoclonal Gammopathy of Undetermined Significance (MGUS)
- •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 (Drug)
Lenalidomide + Dexamethasone + Elotuzumab
干预措施: Elotuzumab (BMS-901608; HuLuc63) (Biological)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization
次要结局
- Progression Free Survival (PFS) Rate at Specific Time-points(From randomization to the specified time-point (up to 5 years))
- Overall Survival (OS)(From randomization to the date of death (up to 8 years))
- Objective Response Rate (ORR)(From randomization to primary completion date (approximately 8 years))
- Mean Change From Baseline of Pain Severity Score and Pain Interference Score(From Baseline to End of Treatment (approximately 8 years))