Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t(11;14)

What this Trial Is About

Researchers are evaluating first-line treatments for systemic AL amyloidosis patients with the t(11;14) genetic marker, aiming to improve early complete hematologic response (CHR). The study focuses on comparing the current combination of daratumumab, bortezomib, and dexamethasone (DBD), which achieves about a 60% CHR rate, with a new approach that adds the Bcl-2 inhibitor venetoclax, especially given its effectiveness for patients with t(11;14). The primary goal is to increase the overall CHR rate at six months. Participants will initially receive daratumumab, bortezomib, and dexamethasone. After seven days, their hematologic response will be evaluated. Those who achieve a rapid response will continue with at least six cycles of daratumumab, venetoclax, and dexamethasone. Patients without a rapid response will also receive this combination but adjusted based on their response. Daratumumab is given intravenously weekly for cycles one and two, then biweekly for cycles three to six. Bortezomib is administered once weekly by subcutaneous injection, and venetoclax is taken daily by mouth. During the study, participants will undergo assessments to monitor their hematologic response at six months, including cardiac, renal, and hepatic function evaluations. Researchers will also track progression-free survival, overall survival, minimal residual disease status, and treatment-related adverse events. The study will last at least six treatment cycles, with ongoing monitoring to assess safety and effectiveness of the treatment combinations.

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