Phase II multisite study to evaluate efficacy and safety of single weekly administration of bortezomib (BZ) and dexmethasone (dex) in newly diagnosed multiple myeloma (NDMM) patients (pts).

Abstract

TPS307 Background: BZ is proteasome inhibitor with demonstrated efficacy in NDMM when given on twice a week (wk) schedule. However, neuropathy is one of the side effects that limit its use in a proportion of pts. Therefore, there is a need to investigate efficacy and safety of a weekly regimen of BZ. Methods: We are conducting a one-stage phase II multicenter, open-label single-arm noninferiority study of once a wk BZ in combination with dex, for the treatment of NDMM in Veterans Hospitals nationwide. The purpose is to show that the study regimen is not inferior to the standard BZ therapy with respect to objective response (OR) rate in pts with NDMM not undergoing transplant. Previously untreated MM pts who are not considered for autologous stem cell transplant (ASCT) due to age > 65 and/or comorbidities, or who are age ≥60 and have declined ASCT are eligible.Pts receive 1.6 mg/m2 IV BZ weekly, for 4 weeks followed by 1 week off. They also receive 40 mg dex PO the day of and day after each dose of BZ. Pat...