Optimizing First-Line Treatment for Systemic AL Amyloidosis with t1114 Using Daratumumab, Venetoclax, Bortezomib, and Dexamethasone

What this Trial Is About

Researchers are evaluating first-line treatment options for systemic AL amyloidosis in patients with the t1114 genetic marker. The study aims to improve early complete hematologic response CHR rates, which are crucial for managing this condition. The trial focuses on optimizing treatment by comparing combinations involving daratumumab, bortezomib, dexamethasone, and venetoclax. The primary goal is to achieve the best overall CHR rate at 6 months. Participants initially receive a combination of daratumumab, bortezomib, and dexamethasone. After 7 days, their hematologic response is assessed. Those with a rapid response continue this treatment for at least six cycles. Those without a rapid response switch to a combination of daratumumab, venetoclax, and dexamethasone. Daratumumab dosing includes weekly intravenous infusions in the first two cycles and biweekly infusions for cycles three to six. Bortezomib is given subcutaneously once weekly, and venetoclax is taken daily. During the study, participants undergo regular evaluations to monitor their hematologic response and organ function, including heart, kidney, and liver assessments at 6 months. Researchers track side effects, progression-free survival, overall survival, and minimal residual disease status. The total participation lasts until at least 6 months post-treatment to assess these outcomes, with safety and treatment response carefully monitored throughout the trial.

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)