NCT03539744进行中（未招募）3 期
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
AbbVie180 个研究点 分布在 4 个国家目标入组 265 人开始时间: 2018年10月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 265
- 试验地点
- 180
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
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 diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
- •Measurable disease at screening as defined per protocol.
- •Has received at least 2 prior lines of therapy as described in the protocol.
- •Has had documented disease progression on or within 60 days after completion of the last therapy.
- •Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
- •Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
- •Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
- •An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.
排除标准
- •History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
- •History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
- •Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
- •Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
- •Known central nervous system involvement of MM.
- •Concurrent conditions as listed in the protocol.
研究组 & 干预措施
Arm 1 VenDex
Experimental
Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
干预措施: Dexamethasone (Drug)
Arm 1 VenDex
Experimental
Venetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
干预措施: Venetoclax (Drug)
Arm 2 PomDex
Active Comparator
Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
干预措施: Pomalidomide (Drug)
Arm 2 PomDex
Active Comparator
Pomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 43 months from first randomization
PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
次要结局
- Time to Deterioration in Disease Symptoms(Up to approximately 51 months from first randomization)
- Time to Deterioration in Physical Functioning(Up to approximately 51 months from first randomization)
- Change from Baseline in PROMIS Fatigue Score(Up to approximately 51 months from first randomization)
- Change from Baseline in BPI-SF Worst Pain Score(Up to approximately 51 months from first randomization)
- Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)(Up to approximately 51 months from first randomization)
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Up to approximately 51 months from first randomization)
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)(Up to approximately 51 months from first randomization)
- Duration of response (DOR)(Up to approximately 43 months from first randomization)
- Overall Response Rate (ORR)(Up to approximately 43 months from first randomization)
- Very Good Partial Response or Better Response Rate (VGPR)(Up to approximately 43 months from first randomization)
- Overall survival (OS)(Up to approximately 51 months from first randomization)
- Minimal Residual Disease (MRD) Negativity Rate(Up to approximately 43 months from first randomization)
- Time to Disease Progression (TTP)(Up to approximately 43 months from first randomization)
- Time to Response (TTR)(Up to approximately 43 months from first randomization)
- Cmax of Venetoclax(Up to approximately 225 days from initial dose)
- Trough Concentration (Ctrough) of Venetoclax(Up to approximately 225 days from initial dose)
- Number of Participants With Adverse Events (AEs)(Up to approximately 51 months from first randomization)
研究者
研究点 (180)
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