EUCTR2020-000713-32-BE进行中（未招募）1 期
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa 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
- 267
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
- •Key Inclusion Criteria:
- •1. AL amyloidosis stage IIIa based on the 2013 European Modification of the 2004 Standard Mayo Clinic Staging in patients with advanced cardiac involvement at the time of
- •2. Measurable hematologic disease at Screening as defined by at least one of the following:
- •a. Involved/uninvolved free light chain difference (dFLC) > 4 mg/dL or
- •b. Involved free light chain (iFLC)> 4 mg/dL with abnormal ratio or
- •c. Serum protein electrophoresis (SPEP) m-spike > 0.5 g/dL
- •3. Histopathological diagnosis of amyloidosis based on polarizing light microscopy of green bi-refringent material in Congo red stained tissue specimens AND confirmation of
- •AL derived amyloid deposits by at least one of the following:
- •a. Immunohistochemistry or
- •b. Mass spectrometry or
- •c. Characteristic electron microscopy appearance
- •4. Cardiac involvement as defined by:
- •a. Documented 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
- •b. At least one of the following:
- •i. Endomyocardial biopsy demonstrating AL cardiac amyloidosis or
- •ii. Echocardiogram demonstrating a mean left ventricular wall thickness (calculated as [IVSd+LPWd]/2) of > 12 mm at diastole in the absence of other
- •causes (e.g., severe hypertension, aortic stenosis), which would adequately explain the degree of wall thickening or
- •iii. Cardiac magnetic resonance imaging (MRI) with gadolinium contrast agent diagnostic of cardiac amyloidosis
- •5. Planned first-line treatment for plasma cell dyscrasia is cyclophosphamide-bortezomibdexamethasone (CyBorD)-based regimen administered as SoC.
- •6. WOCBP must have a negative pregnancy test during Screening and must agree to use highly effective physician approved contraception (Section 6.9) from Screening to 90 days at
- •least 5 months following the last study drug administration or 12 months following the last dose of her PCD therapy, whichever is longer
- •7. Men must be surgically sterile or must agree to use effective physician approved contraception (Section 6.9) and refrain from donating sperm from Screening to 90 days
- •at least 5 months following the last study drug administration or 12 months following the last dose of his PCD therapy, whichever is longer
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •Key Exclusion Criteria:
- •1. Have any other form of amyloidosis other than AL amyloidosis
- •2. Received prior therapy for AL amyloidosis or multiple myeloma. A maximum exposure of 160 mg dexamethasone (or equivalent corticosteroid) since diagnosis of AL amyloidosis
- •and prior to randomization is allowed.
- •3. Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
- •endocrinopathy, monoclonal protein and skin changes) (Appendix A)
- •4. Have supine systolic blood pressure < 90 mmHg or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of > 30 mmHg despite
- •medical management (e.g., midodrine, fludrocortisones) in the absence of volume depletion.
研究者
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A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL AmyloidosisamyloidosisAL amyloidosisNL-OMON51374Alexion Pharmaceuticals, Inc.12