title: Bendamustine and prednisone in combination with bortezomib (BPV) in the treatment of patients with newly diagnosed/untreated multiple myeloma.
abstract: BACKGROUND
  Bortezomib is a proteasome inhibitor that has shown important clinical efficacy either as a single agent or in combination in patients with multiple myeloma (MM). In the present protocol, bortezomib was combined with bendamustine and prednisone, in order to assess the efficacy and safety of this combination therapy in patients with newly diagnosed/untreated MM.
  
  
  METHODS
  Between June 2006 and October 2013, 49 patients with newly diagnosed/untreated MM were treated with bendamustine 60 mg/m(2) on days 1 and 2, bortezomib 1.3 mg/m(2) on days 1, 4, 8 and 11, and prednisone 100 mg on days 1, 2, 4, 8 and 11 bendamustine, prednisone and bortezomib (BPV) once every 21 days. Patients were divided into three groups: group A (n = 19) consisted of patients with normal renal function or mild dysfunction (eGFR ≥ 60 ml/min), group B (n = 15) patients with moderate or severe renal dysfunction (eGFR 15-59 ml/min) and group C (n = 15) patients with renal failure/dialysis (eGFR <15 ml/min).
  
  
  RESULTS
  A median number of two (range 1-5) BPV treatment cycles were given to the patients. The majority of the patients (n = 40, 82 %) responded after at least one cycle of BPV therapy with five stringent complete responses (CRs), nine near complete responses, 12 very good partial responses and 14 partial responses. Five patients had MR, three stable and one progressive disease. After a median observation time of 13 months, progression-free survival (PFS) and overall survival (OS) at 12 months were 92 and 94 %, respectively, for patients with normal renal function or mild renal dysfunction (group A) and 83 and 93 %, respectively, for patients with moderate or severe renal dysfunction (group B). Outcome for these patients was slightly better but not statistically significantly better than that for patients with renal failure/dialysis (group C), who had a PFS, and OS of 66 % (p = 0.08) and 73 % (p = 0.05), respectively. These results indicate that this BPV combination is feasible, effective and well tolerated in patients with newly diagnosed MM and normal or impaired renal function.
authors.affiliation: Department of Hematology, Clinical Oncology and Hemostasiology, University of Leipzig, Leipzig, Germany, Wolfram.Poenisch@medizin.uni-leipzig.de.
authors.forename: Wolfram
authors.initials: W
authors.lastname: Pönisch
authors.forename: Bruno
authors.initials: B
authors.lastname: Holzvogt
authors.forename: Madlen
authors.initials: M
authors.lastname: Plötze
authors.forename: Marc
authors.initials: M
authors.lastname: Andrea
authors.forename: Malvina
authors.initials: M
authors.lastname: Bourgeois
authors.forename: Simone
authors.initials: S
authors.lastname: Heyn
authors.forename: Thomas
authors.initials: T
authors.lastname: Zehrfeld
authors.forename: Doreen
authors.initials: D
authors.lastname: Hammerschmidt
authors.forename: Maik
authors.initials: M
authors.lastname: Schwarz
authors.forename: Thomas
authors.initials: T
authors.lastname: Edelmann
authors.forename: Cornelia
authors.initials: C
authors.lastname: Becker
authors.forename: Franz Albert
authors.initials: FA
authors.lastname: Hoffmann
authors.forename: Andreas
authors.initials: A
authors.lastname: Schwarzer
authors.forename: Ute
authors.initials: U
authors.lastname: Kreibich
authors.forename: Kerstin
authors.initials: K
authors.lastname: Gutsche
authors.forename: Kolja
authors.initials: K
authors.lastname: Reifenrath
authors.forename: Cornelia
authors.initials: C
authors.lastname: Winkelmann
authors.forename: Rainer
authors.initials: R
authors.lastname: Krahl
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Remane
authors.forename: Evelin
authors.initials: E
authors.lastname: Hennig
authors.forename: Thomas
authors.initials: T
authors.lastname: Schliwa
authors.forename: Tom
authors.initials: T
authors.lastname: Lindner
authors.forename: Thorsten
authors.initials: T
authors.lastname: Kaiser
authors.forename: Vladan
authors.initials: V
authors.lastname: Vucinic
authors.forename: Gerhard
authors.initials: G
authors.lastname: Behre
authors.forename: Dietger
authors.initials: D
authors.lastname: Niederwieser
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D018572:Disease-Free Survival; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage; D011241:Prednisone / Q000008:administration & dosage; D011719:Pyrazines / Q000008:administration & dosage; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D001897:Boronic Acids; D009588:Nitrogen Mustard Compounds; D011719:Pyrazines; D000069286:Bortezomib; D000069461:Bendamustine Hydrochloride; D011241:Prednisone