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
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells
研究概览
简要总结
The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 MM and who:
- •Have not received any prior systemic anti-myeloma therapy
- •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 CA204-006 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
Arm 1: Lenalidomide + Dexamethasone
Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug
Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug
干预措施: Lenalidomide (Drug)
Arm 1: Lenalidomide + Dexamethasone
Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug
Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug
干预措施: Dexamethasone (Drug)
Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
Lenalidomide 25 mg capsules by mouth once daily (Days 1-21)
Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)]
Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)]
Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)]
Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)]
Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond)
Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
干预措施: Lenalidomide (Drug)
Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
Lenalidomide 25 mg capsules by mouth once daily (Days 1-21)
Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)]
Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)]
Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)]
Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)]
Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond)
Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
干预措施: Dexamethasone (Drug)
Arm 2: Lenalidomide + Dexamethasone + Elotuzumab
Lenalidomide 25 mg capsules by mouth once daily (Days 1-21)
Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)]
Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)]
Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)]
Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)]
Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond)
Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug
干预措施: Elotuzumab (Biological)
结局指标
主要结局
Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells
时间窗: From baseline (screening) to time of progression (up to approximately 54 months)
CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)
次要结局
- Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression(Time of progression (up to approximately 54 months from pre-treatment screening))
- Levels of CS1 Soluble Form (sCS1) in Serum(At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months))
- Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression(From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months))
- Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells(From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months))
- Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells(From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months))
- CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells(At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months))