A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients.

ABSTRACT:

Purpose

Combinations of bortezomib (Velcade), cyclophosphamide and dexamethasone have shown significant efficacy and safety for patients of newly diagnosed multiple myeloma (NDMM). In this study, we compared the efficacy and safety of modified VCD regimens with novel changes in bortezomib dose and schedule for NDMM.

Methods

Eighty-five NDMM patients from multiple centers were randomly assigned to a high-dose (1.6 mg/m²) (group A) or a low-dose (1.3 mg/m²) (group B) bortezomib, administrated on days 1, 6, 11, and 16 subcutaneously in a 4-week cycle for nine cycles, combined with 40 mg dexamethasone on bortezomib days and cyclophosphamide 300 mg/m² on days 1-3 intravenously.

Results

After four cycles, complete response (CR) or better in

SUBMITTER: Li F 

PROVIDER: S-EPMC11810315 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature