jRCT2031220037招募中不适用
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis (AFFIRM-AL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria for Double-blind Phase:
- •Aged >=18 years and legal age of consent according to local regulations
- •Newly diagnosed and AL amyloidosis treatment naive with cardiac involvement
- •Confirmed diagnosis of AL amyloidosis
- •Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP >=1800 pg/mL and Troponin-T >=0.025 ng/mL or high sensitivity cardiac troponin and dFLC >=18 mg/dL
- •Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly.
- •Inclusion Criteria for Open-label (OLE) Phase:
- •Must not have discontinued treatment in Double-blind Phase
- •Women of childbearing potential must have a negative pregnancy test and must agree to use highly effective contraception through 90 days following last study drug administration
- •Male subjects must be surgically sterile or agree to use highly effective contraception through 90 days following last study drug administration
- •Ability to understand and willingness to sign an ICF prior to initiating the OLE Phase
排除标准
- •Key Exclusion Criteria for Double-blind Phase:
- •Non-AL amyloidosis.
- •NT-proBNP >8500 pg/mL.
- •Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma except for malignancy biomarker of involved /uninvolved serum free light chain ratio >=100
- •Subject is eligible for and plans to undergo ASCT or organ transplant during the study.
- •Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit.
- •Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm^2) or severe congenital heart disease.
- •ECG evidence of acute ischemia or active conduction system abnormalities
- •Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day
- •Prior radiotherapy within 4 weeks of Month 1-Day
- •Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11-1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid .
- •Waldenstrom's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy
- •Exclusion Criteria for OLE Phase:
- •Any medical condition or clinically significant abnormality on physical, neurological, laboratory, vital signs, or ECG examination that precludes treatment with birtamimab or participation in the study, in the medical judgment of the Investigator
- •Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject's ability to safely receive treatment or complete study assessments
- •History of Grade >=3 infusion-related AEs during the Double-blind Phase or hypersensitivity to birtamimab
- •Unable or unwilling to adhere to the study-specified procedures and restrictions
- •Planning to use any other investigational treatment during the study
结局指标
主要结局
-
Time to all-cause mortality for the Double-blind Phase
次要结局
未报告次要终点
研究者
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