title: Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study.
abstract: Bendamustine demonstrated synergistic efficacy with bortezomib against multiple myeloma (MM) cells in vitro and seems an effective treatment for relapsed-refractory MM (rrMM). This phase II study evaluated bendamustine plus bortezomib and dexamethasone (BVD) administered over six 28-day cycles and then every 56 days for six further cycles in patients with rrMM treated with 4 prior therapies and not refractory to bortezomib. The primary study end point was the overall response rate after four cycles. In total, 75 patients were enrolled, of median age 68 years. All patients had received targeted agents, 83% had 1-2 prior therapies and 33% were refractory to the last treatment. The response ratepartial response (PR) was 71.5% (16% complete response, 18.5% very good PR, 37% partial remission). At 12 months of follow-up, median time-to-progression (TTP) was 16.5 months and 1-year overall survival was 78%. According to Cox regression analysis, only prior therapy with bortezomib plus lenalidomide significantly reduced TTP (9 vs 17 months; hazard ratio=4.5; P=0.005). The main severe side effects were thrombocytopenia (30.5%), neutropenia (18.5%), infections (12%), neuropathy (8%) and gastrointestinal and cardiovascular events (both 6.5%). The BVD regimen is feasible, effective and well-tolerated in difficult-to-treat patients with rrMM.
authors.affiliation: Clinica di Ematologia, Azienda Ospedaliero-Universitaria, Ospedali Riuniti di Ancona, Ancona, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Offidani
authors.forename: L
authors.initials: L
authors.lastname: Corvatta
authors.forename: L
authors.initials: L
authors.lastname: Maracci
authors.forename: A M
authors.initials: AM
authors.lastname: Liberati
authors.forename: S
authors.initials: S
authors.lastname: Ballanti
authors.forename: I
authors.initials: I
authors.lastname: Attolico
authors.forename: P
authors.initials: P
authors.lastname: Caraffa
authors.forename: F
authors.initials: F
authors.lastname: Alesiani
authors.forename: T
authors.initials: T
authors.lastname: Caravita di Toritto
authors.forename: S
authors.initials: S
authors.lastname: Gentili
authors.forename: P
authors.initials: P
authors.lastname: Tosi
authors.forename: M
authors.initials: M
authors.lastname: Brunori
authors.forename: D
authors.initials: D
authors.lastname: Derudas
authors.forename: A
authors.initials: A
authors.lastname: Ledda
authors.forename: A
authors.initials: A
authors.lastname: Gozzetti
authors.forename: C
authors.initials: C
authors.lastname: Cellini
authors.forename: L
authors.initials: L
authors.lastname: Malerba
authors.forename: A
authors.initials: A
authors.lastname: Mele
authors.forename: A
authors.initials: A
authors.lastname: Andriani
authors.forename: S
authors.initials: S
authors.lastname: Galimberti
authors.forename: P
authors.initials: P
authors.lastname: Mondello
authors.forename: S
authors.initials: S
authors.lastname: Pulini
authors.forename: U
authors.initials: U
authors.lastname: Coppetelli
authors.forename: P
authors.initials: P
authors.lastname: Fraticelli
authors.forename: A
authors.initials: A
authors.lastname: Olivieri
authors.forename: P
authors.initials: P
authors.lastname: Leoni