title: Combined bendamustine, prednisone and bortezomib (BPV) in patients with relapsed or refractory multiple myeloma.
abstract: BACKGROUND
  Bortezomib (Velcade) is a proteasome inhibitor that has shown important clinical efficacy either as a single agent or in combination with other cytostatic agents in multiple myeloma (MM). In the present protocol, bortezomib was combined with other active substances like bendamustine and prednisone (BPV), in order to assess the efficacy and toxicity of the combination therapy in patients with relapsed or refractory MM.
  
  
  METHODS
  Between January 2005 and December 2011, 78 patients with relapsed or refractory MM were treated with bendamustine 60 (-120) 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. The median number of prior therapies was 2 with a wide range of 1-9. Thirty-three patients had pre-existing severe thrombocytopenia and/or neutropenia (WHO grade 3 or 4).
  
  
  RESULTS
  A median number of two (range 1-7) BPV treatment cycles were given to the patients. The majority of the patients (n = 54; 69 %) responded after at least one cycle of chemotherapy with 3 CR, 10 nCR, 10 VGPR and 31 PR. Median PFS and OS for patients without severe hematological toxicities due to previous treatments (n = 45) were 11 and 50 months, respectively. Outcome for these patients was significantly better than that for patients with severe hematological toxicities (grade 3 or 4, n = 33) with a PFS, and OS of 3 months (p < 0.05) and 5 months (p < 0.001), respectively. The regimen was well tolerated with few significant side effects in patients without severe hematological toxicities due to previous treatments. These results indicate that the combination of bortezomib, bendamustine and prednisone is well tolerated in patients with relapsed or refractory MM.
authors.affiliation: Department of Hematology and Oncology, University of Leipzig, Johannisallee 32A, 04103 Leipzig, Germany. Wolfram.Poenisch@medizin.uni-leipzig.de
authors.forename: Wolfram
authors.initials: W
authors.lastname: Pönisch
authors.forename: Malvina
authors.initials: M
authors.lastname: Bourgeois
authors.forename: Barbara
authors.initials: B
authors.lastname: Moll
authors.forename: Simone
authors.initials: S
authors.lastname: Heyn
authors.forename: Nadja
authors.initials: N
authors.lastname: Jäkel
authors.forename: Ina
authors.initials: I
authors.lastname: Wagner
authors.forename: Robert
authors.initials: R
authors.lastname: Rohrberg
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Hurtz
authors.forename: Marion
authors.initials: M
authors.lastname: Schmalfeld
authors.forename: Michael
authors.initials: M
authors.lastname: Aßmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Edelmann
authors.forename: Martin
authors.initials: M
authors.lastname: Mohren
authors.forename: Franz Albert
authors.initials: FA
authors.lastname: Hoffmann
authors.forename: Cornelia
authors.initials: C
authors.lastname: Becker
authors.forename: Andreas
authors.initials: A
authors.lastname: Schwarzer
authors.forename: Uta
authors.initials: U
authors.lastname: Schönfelder
authors.forename: Thomas
authors.initials: T
authors.lastname: Zehrfeld
authors.forename: Gerald
authors.initials: G
authors.lastname: Hensel
authors.forename: Kerstin
authors.initials: K
authors.lastname: Löschcke
authors.forename: Rainer
authors.initials: R
authors.lastname: Krahl
authors.forename: Haifa Al
authors.initials: HA
authors.lastname: Ali
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* / Q000009:adverse effects; D000069286:Bortezomib; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D011719:Pyrazines / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D012189:Retrospective Studies
chemical_list: D001897:Boronic Acids; D009588:Nitrogen Mustard Compounds; D011719:Pyrazines; D000069286:Bortezomib; D000069461:Bendamustine Hydrochloride; D011241:Prednisone