title: A Phase II trial of weekly bortezomib and dexamethasone in veterans with newly diagnosed multiple myeloma not eligible for or who deferred autologous stem cell transplantation.
abstract: Once-weekly administration of bortezomib has reduced bortezomib-induced peripheral neuropathy without affecting response rates, but this has only been demonstrated prospectively in three- and four- drug combinations. We report a phase II trial of alternate dosing and schedule of bortezomib and dexamethasone in newly diagnosed multiple myeloma patients who are not eligible for or refused autologous stem cell transplantation. Bortezomib 1·6 mg/m(2) intravenously was given once-weekly for six cycles, together with dexamethasone 40 mg on the day of and day after bortezomib. Fifty patients were enrolled; 58% did not require any dose modification. The majority of patients had multiple co-morbidities, including cardiovascular (76%) and renal insufficiency (54%), and the median number of medications prior to enrollment was 13. Of all evaluable patients, the overall response rate was 79% and at least 45% had at least a very good partial response. The median time to first response was 1·3 months (range, 0·25-2·4 months). The progression-free and overall survivals were 8 months and 46·5 months, respectively. Twenty-four percent developed worsening neuropathy. We conclude that alternate dosing and scheduling of bortezomib and dexamethasone is both safe and effective for management of newly diagnosed multiple myeloma in frail patients. (ClinicalTrials.gov number, NCT01090921).
authors.affiliation: VA Boston Healthcare System, Boston, MA, USA; University of Cincinnati College of Medicine, Cincinnati, OH, USA.
authors.forename: Saulius K
authors.initials: SK
authors.lastname: Girnius
authors.forename: Saem
authors.initials: S
authors.lastname: Lee
authors.forename: Suman
authors.initials: S
authors.lastname: Kambhampati
authors.forename: Michal G
authors.initials: MG
authors.lastname: Rose
authors.forename: Abid
authors.initials: A
authors.lastname: Mohiuddin
authors.forename: Antoun
authors.initials: A
authors.lastname: Houranieh
authors.forename: Abraham
authors.initials: A
authors.lastname: Zimelman
authors.forename: Terrence
authors.initials: T
authors.lastname: Grady
authors.forename: Paulette
authors.initials: P
authors.lastname: Mehta
authors.forename: Caroline
authors.initials: C
authors.lastname: Behler
authors.forename: Teresa G
authors.initials: TG
authors.lastname: Hayes
authors.forename: Yvonne A
authors.initials: YA
authors.lastname: Efebera
authors.forename: Rao H
authors.initials: RH
authors.lastname: Prabhala
authors.forename: Andrew
authors.initials: A
authors.lastname: Han
authors.forename: Sarvari V
authors.initials: SV
authors.lastname: Yellapragada
authors.forename: Catherine E
authors.initials: CE
authors.lastname: Klein
authors.forename: Garson D
authors.initials: GD
authors.lastname: Roodman
authors.forename: Alan
authors.initials: A
authors.lastname: Lichtenstein
authors.forename: Nikhil C
authors.initials: NC
authors.lastname: Munshi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D064592:Autografts; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D003907:Dexamethasone; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality; D011719:Pyrazines / Q000008:administration & dosage; D033581:Stem Cell Transplantation; D015996:Survival Rate; D014728:Veterans
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone
keywords: bortezomib; co-morbidities; multiple myeloma; transplant ineligible