An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 44
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.
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
- •≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
- •Documented refractory or relapsed and refractory multiple myeloma
- •Refractory to proteosome inhibitor and lenalidomide, and to last treatment
- •Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment
- •Measurable disease at screening
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
排除标准
- •Active plasma cell leukemia
- •Prior treatment with pomalidomide
- •Unable to tolerate thromboembolic prophylaxis while on the study
- •Prior autologous stem cell transplant within 12 weeks
- •Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
研究组 & 干预措施
Elotuzumab Arm
Biological:Elotuzumab (BMS-901608; HuLuc63)
- Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22)
- Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1)
Drug: Pomalidomide
•Capsules,Oral,4 mg,once daily, on Days 1-21
Other Name: Pomalyst
Drug: Dexamethasone
- Subjects ≤ 75 years old:
•Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond)
- Subjects > 75 years old:
•Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond)
Other Names:
Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak
干预措施: Elotuzumab (Drug)
Elotuzumab Arm
Biological:Elotuzumab (BMS-901608; HuLuc63)
- Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22)
- Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1)
Drug: Pomalidomide
•Capsules,Oral,4 mg,once daily, on Days 1-21
Other Name: Pomalyst
Drug: Dexamethasone
- Subjects ≤ 75 years old:
•Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond)
- Subjects > 75 years old:
•Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond)
Other Names:
Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak
干预措施: Pomalidomide (Drug)
Elotuzumab Arm
Biological:Elotuzumab (BMS-901608; HuLuc63)
- Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22)
- Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1)
Drug: Pomalidomide
•Capsules,Oral,4 mg,once daily, on Days 1-21
Other Name: Pomalyst
Drug: Dexamethasone
- Subjects ≤ 75 years old:
•Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond)
- Subjects > 75 years old:
•Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond)
•Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond)
Other Names:
Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak
干预措施: Dexamethasone (Drug)
Control Arm
Drug: Pomalidomide
• Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst
Drug: Dexamethasone
Subjects ≤ 75 years old:
• Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22
Subjects > 75 years old:
• Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22,
Other Names:
- Decadron
- Dexamethasone Intensol
- Dexpak
- Taperpak
干预措施: Pomalidomide (Drug)
Control Arm
Drug: Pomalidomide
• Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst
Drug: Dexamethasone
Subjects ≤ 75 years old:
• Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22
Subjects > 75 years old:
• Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22,
Other Names:
- Decadron
- Dexamethasone Intensol
- Dexpak
- Taperpak
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From randomization to date of progression or death (up to approximately 21 months)
PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
次要结局
- Objective Response Rate (ORR)(From first dose to disease progression (up to approximately 21 months))
- Overall Survival (OS)(From randomization to death (up to approximately 52 months))