EUCTR2021-000037-14-DE进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Aged =18 years and legal age of consent according to local regulations
- •2.Newly diagnosed and AL amyloidosis treatment naive with cardiac involvement
- •3.Confirmed diagnosis of AL amyloidosis
- •4.Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP = 1800 pg/mL and Troponin-T =0.025 ng/mL (mcg/L) or high sensitivity cardiac troponin T =40 ng/L and dFLC =18 mg/dL
- •5.Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly
- •A comprehensive list of inclusion criteria can be found in the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1.Non-AL amyloidosis
- •2.NT-proBNP >8500 pg/mL
- •3.Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma, except for malignancy biomarker of involved/and uninvolved serum free light chain ratio =100
- •4.Subject is eligible for and plans to undergo ASCT or organ transplant during the study
- •5.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
- •6.Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
- •7.ECG evidence of acute ischemia or active conduction system abnormalities
- •8.Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1
- •9.Prior radiotherapy within 4 weeks of Month 1-Day 1
- •10.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
- •11.Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy
- •A comprehensive list of exclusion criteria can be found in the protocol.
研究者
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