Phase 2 Study of Bortezomib, Pomalidomide, and Dexamethasone for Treatment of Systemic AL Amyloidosis in Adults

What this Trial Is About

Researchers are evaluating a treatment regimen for people with systemic light chain AL amyloidosis, a condition where abnormal proteins build up in organs. This open-label, multicenter Phase 2 study focuses on patients who are either newly diagnosed or have been previously treated for this type of amyloidosis. The study aims to assess the effect of combining bortezomib, pomalidomide, and dexamethasone, especially since many patients face kidney involvement that limits other treatment options. The study treatment involves a combination of three drugs bortezomib, given as a weekly injection pomalidomide, taken orally daily for 21 days in each 28-day cycle and dexamethasone, taken weekly. Participants will receive this regimen every 28 days for up to six cycles or until the disease progresses, unacceptable side effects occur, or another therapy is needed. This approach is designed to explore how these drugs work together in treating systemic AL amyloidosis. Participants will be closely monitored during the study, with researchers tracking responses in blood and organ function, including very good partial response and complete response rates at 6 months. Additional measurements include overall hematologic response, organ responses, time to next treatment, and survival estimates over two years. Safety and side effects will also be evaluated. The total study period includes regular assessments to understand how well the treatment works and its impact on health over time.

Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis