A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis [NEXICART-3]
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 主要终点
- Overall complete hematologic response (CHR) rate using consensus recommendations for AL amyloidosis treatment response criteria per protocol
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
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
- •Eastern Cooperative Oncology Group performance status score ≤2
- •Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol
- •Measurable disease as defined in the protocol
- •One or more organs impacted by AL amyloidosis
排除标准
- •Prior therapy for AL amyloidosis or multiple myeloma
- •Diagnosis of multiple myeloma
- •Cardiac stage IIIb patients
- •History of malignancy (other than AL amyloidosis) within 3 years
- •Stroke or seizure within 6 months of signing ICF
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
结局指标
主要结局
Overall complete hematologic response (CHR) rate using consensus recommendations for AL amyloidosis treatment response criteria per protocol
时间窗: 24 months
CHR rate is defined as percentage of participants who achieved CHR
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
时间窗: 60 months
MOD-PFS is defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurs first
次要结局
未报告次要终点