A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis (AFFIRM-AL)

study id #: NEOD001-301

condition: Light Chain (AL) Amyloidosis

status: Recruiting

intervention: Drug: Birtamimab Other: Placebo Drug: Standard of Care Chemotherapy

results: https://clinicaltrials.gov/study/NCT04973137

last updated: December 12, 2024

start date: 2021-08-30

estimated completion: 2025-06

phase of development: Phase 3

size / enrollment: 220

primary outcomes:

• Time to all-cause mortality for the Double Blind Phase

secondary outcomes:

• 6MWT distance for the Double Blind Phase
  Physical Component Summary score of the Short Form-36, version 2 for the Double Blind Phase

inclusion criteria:

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
Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy

sponsor: Prothena Biosciences Ltd.

contacts: Prothena Biosciences Ltd., 650-837-8550, [email protected]

trial center locations: