Daratumumab bortezomib and dexamethasone in transplant ineligible newly diagnosed elderly myeloma patients (AMN006)-a trial by Asian Myeloma Network (NCT03695744).

AMN006 is a prospective, single-arm, phase 2 study evaluating the efficacy and safety of daratumumab, bortezomib, and dexamethasone (DVd) in elderly, transplant-ineligible (TI) patients with newly diagnosed multiple myeloma (NDMM). The primary end point was overall response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. 27 patients were enrolled between October 2019 and September 2021. Treatment comprised fixed-duration DVd (9 months) followed by daratumumab maintenance until progression or toxicity. At a median follow-up of 27 months, the ORR was 96.3%, ≥CR in 29.6% and VGPR in 51.9%. Among patients achieving ≥ CR, 7/8 were MRD-negative (sensitivity 10-5). Median PFS was 36.5 months; median OS was not reached. The regimen was well tolerated, with treatment-emergent adverse events related to study drugs in 22% of patients. These findings support the feasibility of time-limited DVd and daratumumab maintenance as an effective and tolerable frontline approach for TI NDMM patients. Trial Registration: NCT03695744.