EUCTR2021-000037-14-IT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. PlaceboPlus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •2.Newly diagnosed and AL amyloidosis treatment naive
- •3.Bone marrow demonstrating clonal plasma cells
- •4.Confirmed diagnosis of AL amyloidosis by the following:
- •-Histochemical diagnosis of amyloidosis determined by polarizing light
- •microscopy of green birefringent material in Congo red-stained tissue
- •specimens OR characteristic electron microscopy appearance
- •-Confirmatory immunohistochemistry OR mass spectroscopy of AL
- •amyloidosis
- •5.Confirmed diagnosis of AL amyloidosis by mass spectrometry or
- •immunoelectron microscopy of amyloid material in tissue biopsy if the
- •subject meets any of the following:
- •-Is black or African American
- •-Is over 75 years of age with concurrent monoclonal gammopathy
- •-Has a history of familial amyloidosis and has concurrent monoclonal
- •-If the subject meets any of the above 3 conditions and has
- •echocardiographic evidence of amyloidosis, biopsy-proven amyloidosis
- •with a monoclonal gammopathy and no tissue is available for mass
- •spectrometry or immunoelectron microscopy, the subject must have
- •gene sequencing consistent with transthyretin (TTR) wild type (e.g., no
- •TTR mutation present) AND must score 0 in technetium-99m-3,3-
- •diphosphono-1,2 propanodicarboxylic acid (99mTc DPD),
- •hydroxymethylenediphosphonate (99mTc HMDP), or pyrophosphate
- •(99mTc PYP) scintigraphy
- •6.Cardiac involvement as defined by all of the following:
- •-Past documented or presently noted clinical signs and symptoms
- •supportive of a diagnosis of heart failure in the setting of a confirmed
- •diagnosis of AL amyloidosis in the absence of an alternative explanation
- •for heart failure
- •-Either an endomyocardial biopsy demonstrating AL amyloidosis or an
- •echocardiogram demonstrating a mean left ventricular wall thickness at
- •diastole >12 mm in the absence of other causes (e.g., severe
- •hypertension, aortic stenosis), which would adequately explain the
- •degree of wall thickening
- •7.Confirmed Mayo Stage IV as defined by:
- •-NT-proBNP =1800 pg/mL and
- •-Troponin-T >0.03 ng/mL and
- •-dFLC =18 mg/dL
- •8.Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly
- •9.Adequate bone marrow reserve, hepatic function, and renal function,
- •as demonstrated by:
- •-Absolute neutrophil count =1.0 × 10e9/L
- •-Platelet count =75 × 10e9/L
- •-Hemoglobin =9 g/dL
- •-Total bilirubin = 2 × the upper limit of normal (ULN)
- •-Aspartate aminotransferase (AST)/serum glutamic oxaloacetic
- •transaminase =3 × ULN
- •-Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase
- •-Alkaline phosphatase (ALP) =5 × ULN (except for subjects with
- •hepatomegaly and isozymes specific to liver, rather than bone)
- 另有 15 项未显示
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
- •*Note that subjects who meet the IMWG definition of symptomatic
- •multiple myeloma with signs and/or symptoms attributable only to
- •associated amyloidosis are potentially eligible upon approval of the
- •4.Subject is eligible for and plans to undergo ASCT or organ transplant
- •during the study
- •5.Symptomatic orthostatic hypotension that in the medical judgment of
- •the Investigator would interfere with the subject's ability to safely
- •receive treatment or complete study assessments
- •6.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
- •7.Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve
- •area <1.0 cm2) or severe congenital heart disease
- •8.ECG evidence of acute ischemia or active conduction system
- •abnormalities with the exception of any of the following:
- •-First degree AV-block
- •-Second degree AV-block Type 1 (Mobitz Type 1 / Wenckebach type)
- •-Right or left bundle branch block
- •-Atrial fibrillation with a controlled ventricular rate (uncontrolled [>110
- •bpm] ventricular rate is not allowed [determined by an average of 3
- •beats in Lead II or 3 representative beats if Lead II is not representative
- •of the overall ECG])
- •9.Peripheral neuropathy assessed as National Cancer Institute-Common
- •Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 2 with pain,
- •Grade 3, or Grade 4
- •10.Subject is receiving oral or intravenous antibiotics, antifungals, or
- •antivirals within 1 week of Month 1-Day 1 with the exception of
- •prophylactic oral agents
- •11.Prior treatment with hematopoietic growth factors, transfusions of
- •blood or blood products within 1 week of Month 1-Day 1
- •12.Prior radiotherapy within 4 weeks of Month 1-Day 1
- •13.Major surgery within 4 weeks of Month 1-Day 1 or planned major
- •surgery during the study
- •14.Active malignancy with the exception of any of the following:
- •-Adequately treated basal cell carcinoma, squamous cell carcinoma, or in
- •situ cervical cancer
- •-Adequately treated Stage I cancer from which the subject is currently in
- •remission and has been in remission for 2 years
- •-Low-risk prostate cancer with Gleason score <7 and prostate specific
- •antigen <10 ng/mL
- •-Any other cancer from which the subject has been disease-free for =2
- •15.History of severe allergy to any of the components of birtamimab
- •such as histidine/L histidine hydrochloride monohydrate, trehalose
- •dehydrate, or polysorbate 20 or history of Grade =3 infusion-related AEs
- •or hypersensitivity to another monoclonal antibody, or known
- •hypersensitivity to diphenhydramine (or an equivalent H1 antihistamine)
- 另有 13 项未显示
研究者
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