A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Hematologic
Phase III
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics,
Therapy (NOS)
Birtamimab,
Bortezomib (BTZ),
Cyclophosphamide,
Daratumumab,
Dexamethasone,
Placebo
Baljevic, Muhamed
International
Vanderbilt University
03-18-2024
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
Aged 18 years and legal age of consent according to local regulations
Newly diagnosed and AL amyloidosis treatment-nave with cardiac involvement
Confirmed diagnosis of AL amyloidosis
Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP 1800 pg/mL and Troponin-T 0.025 ng/mL or high sensitivity cardiac troponin T40ng/L and dFLC 18 mg/dL
Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly.
Exclusion Criteria:
Non-AL amyloidosis.
NT-proBNP >8500 pg/mL.
Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma except for malignancy biomarker of involved/uninvolved serum free light chain ratio 100
Subject is eligible for and plans to undergo ASCT or organ transplant during the study.
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.
Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area 1.0 cm2) or severe congenital heart disease.
ECG evidence of acute ischemia or active conduction system abnormalities
Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1.
Prior radiotherapy within 4 weeks of Month 1-Day 1.
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 .
Waldenstrm's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy
Aged 18 years and legal age of consent according to local regulations
Newly diagnosed and AL amyloidosis treatment-nave with cardiac involvement
Confirmed diagnosis of AL amyloidosis
Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP 1800 pg/mL and Troponin-T 0.025 ng/mL or high sensitivity cardiac troponin T40ng/L and dFLC 18 mg/dL
Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly.
Exclusion Criteria:
Non-AL amyloidosis.
NT-proBNP >8500 pg/mL.
Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma except for malignancy biomarker of involved/uninvolved serum free light chain ratio 100
Subject is eligible for and plans to undergo ASCT or organ transplant during the study.
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.
Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area 1.0 cm2) or severe congenital heart disease.
ECG evidence of acute ischemia or active conduction system abnormalities
Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1.
Prior radiotherapy within 4 weeks of Month 1-Day 1.
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 .
Waldenstrm's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy
