NL-OMON54039招募中3 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 - Efficacy and Safety of Birtamimab in Mayo Stage 4 AL; NEOD001-301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Double-blind Phase:
- •1.Aged >=18 years and legal age of consent according to local regulations
- •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 AND
- •-Confirmatory immunohistochemistry OR immunoelectron microscopy OR mass
- •spectroscopy of AL amyloidosis
- •5.If the subject meets any of the following:
- •-Is black or of African descent
- •-Is over 75 years of age
- •-Has a history of familial transthyretin amyloidosis
- •-No cardiac tissue is available for typing, THEN the subject must have gene
- •sequencing consistent with transthyretin (TTR) wild type (i.e., no TTR mutation
- •present) AND must score 0 in technetium-99m-3,3-diphosphono-1,2
- •propanodicarboxylic acid (99mTc DPD; Rapezzi 2011),
- •hydroxymethylenediphosphonate (99mTc HMDP; Galat 2015), OR pyrophosphate (99mTc
- •PYP; Bokhari 2013) 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 OR
- •cardiovascular magnetic resonance imaging findings reported as characteristic
- •of amyloidosis
- •7.Confirmed Mayo Stage IV as defined by:
- •-NT-proBNP >=1800 pg/mL and
- •-Troponin-T >=0.025 ng/mL (mcg/L) or high sensitivity cardiac troponin T >=40
- •-Difference between involved and uninvolved free light chain >=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) (except for subjects
- •with Gilbert*s syndrome, in which case direct bilirubin <=2 × ULN)
- •-Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase <=3 ×
- •-Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase <=3 × ULN
- •-Alkaline phosphatase (ALP) <=5 × ULN
- •-Estimated glomerular filtration rate (eGFR) >=30 mL/min/1.73 m2 as estimated by
- •the Chronic Kidney Disease Epidemiology Collaboration equation
- •10.Seated systolic blood pressure (BP) 90 to 180 mmHg
- •11.Distance walked during each Screening 6MWT is >30 meters and <550 meters
- 另有 6 项未显示
排除标准
- •Double-blind Phase:
- •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/uninvolved serum free
- •light chain ratio >=100 (Appendix 3)
- •4. Subject is eligible for and plans to undergo ASCT or organ transplant during
- •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 electrocardiographic (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,
- •10. Subject is receiving oral or intravenous antibiotics, antifungals, or
- •antivirals within 1 week of Month 1-Day 1 with the exception of prophylactic
- •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 cutaneous 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 prostate-specific antigen <10
- •ng/mL, and a stage of cancer at most cT2a, cN0, and CM0
- •Any other cancer from which the subject has been disease-free for >=2 years
- •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 adverse events (AEs) or
- •hypersensitivity to another monoclonal antibody, or known hypersensitivity to
- •diphenhydramine (or an equivalent H1 antihistamine) or acetaminophen (or its
- •equivalent, paracetamol)
- •16. Known unresolved or active HIV, hepatitis B, hepatitis C, or SARS-CoV-2
- •17. Prior treatment with plasma cell-directed chemotherapy, birtamimab,
- •daratumumab, 11-1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or
- 另有 4 项未显示
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