EUCTR2014-003865-11-FR进行中（未招募）1 期
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis
Prothena Therapeutics Limited0 个研究点目标入组 236 人开始时间: 2015年7月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 236
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
- •Subjects must meet all of the following criteria:
- •1. Aged = 18 years
- •2. Newly diagnosed and AL amyloidosis treatment naïve
- •3. Bone marrow consistent with plasma cell dyscrasia within 42 days prior to Month 1-Day 1
- •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 mass spectroscopy of AL amyloidosis
- •5. Confirmed diagnosis of AL amyloidosis by mass spectrometry of 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 gammopathy
- •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
- •Echocardiogram demonstrating a mean left ventricular wall thickness > 12 mm in the absence of other cardiac cause to explain wall thickening (such as hypertension or cardiac valvular disease)
- •NT-proBNP = 650 pg/mL in the absence of renal failure or atrial fibrillation with an uncontrolled ventricular rate
- •7. Planned first-line chemotherapy contains bortezomib administered weekly and SC
- •8. Adequate bone marrow reserve, hepatic and renal function, as demonstrated by: absolute neutrophil count (ANC) = 1.0 x10^9/L
- •platelet count = 75 x 10^9/L
- •hemoglobin = 9 g/dL
- •total bilirubin = 2 x upper limit of normal (ULN)
- •aspartate aminotransferase (AST) / serum glutamic oxaloacetic transaminase (SGOT) = 3 x ULN
- •alanine aminotransferase (ALT) / serum glutamic pyruvic transaminase (SGPT) = 3 x ULN
- •alkaline phosphatase (ALP) = 5 x ULN (except for patients with hepatomegaly and isozymes specific to liver, rather than bone)
- •estimated glomerular filtration rate (eGFR) = 30 mL/min
- •9. Seated systolic blood pressure 90-180 mmHg
- •10. Distance walked during 6MWT is =30 meters and =550 meters
- •11. Women of childbearing potential (WOCBP) must have two negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of study drug and must agree to use physician-approved contraception from Screening to 30 days following the last study drug administration
- •12. Male subjects must be surgically sterile or must agree to use physician-approved contraception from Screening to 30 days following the last study drug administration
- •13. Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Subjects must meet none of the following criteria:
- •1. Non-AL amyloidosis
- •2. NT-proBNP > 8,500 pg/mL
- •3. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma (see Appendix 11)
- •*Note that subjects who meet the IMWG definition of symptomatic multiple myeloma with signs and/or symptoms attributable only to associated amyloidosis and who do not otherwise meet the criteria for diagnosis of smoldering myeloma are potentially eligible upon approval of the Sponsor.
- •4. Subject is eligible for and plans to undergo ASCT
- •5. 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
- •6. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic 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
- •Prior to randomization, any ECG screening abnormalities must be noted as not clinically significant” by the Investigator
- •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 IV 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
- •Stage I prostate cancer that does not require treatment
- •Any other cancer from which the subject has been disease-free for = 2 years
- •15. History of Grade = 3 infusion-associated AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine (or an equivalent H1 antihistamine) or acetaminophen (or its equivalent, paracetamol)
- •16. Uncontrolled, active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
- •17. Prior treatment with NEOD001
- •18. Treatment with another investigational agent within 30 days of Month 1-Day 1
- •19. Women who are pregnant or lactating
- •20. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject’s risk by participating in the study
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