Table 1 Relevant phase 3 randomized studies incorporating anti-fibril monoclonal antibodies to the frontline treatment of systemic light chain amyloidosis.
From: Relapsed systemic light chain amyloidosis – in search of a higher bar
Study Name | ClinicalTrials.gov Identifier | Estimated Enrollment | Randomization | Masking | Primary Endpoint |
|---|---|---|---|---|---|
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 | NCT04512235 | 267 | 2:1 experimental to control | Quadruple: Participant Care Provider Investigator Outcomes Assessor | Time to All-cause Mortality |
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 IIIb AL Amyloidosis | NCT04504825 | 124 | Time to All-cause Mortality or to the end of the PETP | ||
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis | NCT04973137 | 150 | Time to All-cause Mortality |
