A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis (AFFIRM-AL)
Categories (click each to see list of all clinical trials associated with that category): Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Holstein, Sarah
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04973137?term=NCT04973137&rank=1
Summary
Primary Objective: To evaluate the efficacy of birtamimab plus standard of care compared to placebo plus standard of care when administered intravenously in Mayo Stage IV subjects with AL amyloidosis by assessing time to
all-cause mortality.
Secondary Objectives: To evaluate birtamimab plus standard of care compared to placebo plus standard of care on the following: Change from baseline to Month 9 in health-related quality of life using the Short Form-36 questionnaire Version 2 (SF-36v2) Change from baseline to Month 9 in the 6-Minute Walk Test (6MWT) distance