title: Bortezomib, ascorbic acid and melphalan (BAM) therapy for patients with newly diagnosed multiple myeloma: an effective and well-tolerated frontline regimen.
abstract: BACKGROUND
  We conducted a single-arm, multicentre phase 2 study to evaluate bortezomib, ascorbic acid and melphalan (BAM) for patients with newly diagnosed multiple myeloma (MM).
  
  
  METHODS
  Induction consisted of up to eight 28-d cycles of bortezomib 1.0 mg/m(2) on days 1, 4, 8 and 11, plus oral ascorbic acid 1 g and oral melphalan 0.1 mg/kg on days 1-4, followed by maintenance bortezomib 1.3 mg/m(2) every 2 wk until progression.
  
  
  RESULTS
  Among 35 patients enrolled (median age 70 yr), responses occurred in 23/31 evaluable patients (74%) including five (16%) complete, three (10%) very good partial, six (19%) partial and nine (29%) minimal responses. Six patients (19%) had stable disease. Thus, disease control was achieved in 29 (94%) patients. Median times to first and best responses were 2 and 3 months (ranges 1-5 and 1-7), respectively. Median time to progression was 19 months and median overall survival has not been reached (range 2-23+ months). Grade 3 and 4 adverse events occurred in 17 and 5 patients, respectively; the most common were neutropenia, neuropathy and thrombocytopenia.
  
  
  CONCLUSIONS
  BAM is an efficacious, well-tolerated and steroid- and immunomodulatory drug (IMiD)-free frontline treatment regimen for MM patients.
authors.affiliation: Oncotherapeutics, Los Angeles, CA, USA. jberenson@imbcr.org
authors.forename: James R
authors.initials: JR
authors.lastname: Berenson
authors.forename: Ori
authors.initials: O
authors.lastname: Yellin
authors.forename: Donald
authors.initials: D
authors.lastname: Woytowitz
authors.forename: Marshall S
authors.initials: MS
authors.lastname: Flam
authors.forename: Alan
authors.initials: A
authors.lastname: Cartmell
authors.forename: Ravi
authors.initials: R
authors.lastname: Patel
authors.forename: Herb
authors.initials: H
authors.lastname: Duvivier
authors.forename: Youram
authors.initials: Y
authors.lastname: Nassir
authors.forename: Benjamin
authors.initials: B
authors.lastname: Eades
authors.forename: Christina Dilauro
authors.initials: CD
authors.lastname: Abaya
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Hilger
authors.forename: Regina A
authors.initials: RA
authors.lastname: Swift
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use / Q000633:toxicity; D001205:Ascorbic Acid / Q000008:administration & dosage*; D001897:Boronic Acids / Q000008:administration & dosage*; D000069286:Bortezomib; D006801:Humans; D008558:Melphalan / Q000008:administration & dosage*; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011719:Pyrazines / Q000008:administration & dosage*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D001205:Ascorbic Acid; D008558:Melphalan