title: Retreatment with bortezomib alone or in combination for patients with multiple myeloma following an initial response to bortezomib.
abstract: This clinical trial was conducted to determine the safety and efficacy of bortezomib retreatment in patients with multiple myeloma (MM) who had previously responded to bortezomib. Patients with progressive MM who had previously tolerated bortezomib as a single agent or in combination with other drugs, with a minimum of partial response (PR; >or=50% M-protein reduction) for >or=4 months, who had not received intervening MM therapy, were retreated with bortezomib (days 1, 4, 8, and 11 of a 21-day cycle) with a starting dose being the dose at which the patient ended the initial treatment. Patients were allowed to receive bortezomib on retreatment in combination with dexamethasone, thalidomide, or doxorubicin. Thirty-two patients received bortezomib retreatment (most with added dexamethasone). The median treatment-free interval (last dose of initial bortezomib treatment to first dose of retreatment) was 9.9 (range 2.5-34.0) months. The median duration of retreatment was 2.8 (<1-7.9) months; median total duration of bortezomib treatment was 6.7 (2.5-19.8) months. Based on the investigators' assessment of best response, the overall response rate (complete plus PR) was 50%. The median time from start of retreatment to progressive disease (PD) was 6.6 (95% confidence interval: 5.1-9.6) months. Thirteen patients (41%) experienced PN; bortezomib-related SAEs were reported in four patients. Retreatment with bortezomib alone or in combination is effective and well tolerated in patients with MM who have responded to their initial bortezomib treatment.
authors.affiliation: Raman Sood Physician PC, Dunkirk, New York, USA. rsood@dnamail.com
authors.forename: Raman
authors.initials: R
authors.lastname: Sood
authors.forename: Harry
authors.initials: H
authors.lastname: Carloss
authors.forename: Robert
authors.initials: R
authors.lastname: Kerr
authors.forename: Jose
authors.initials: J
authors.lastname: Lopez
authors.forename: Martin
authors.initials: M
authors.lastname: Lee
authors.forename: Mark
authors.initials: M
authors.lastname: Druck
authors.forename: Ian B
authors.initials: IB
authors.lastname: Walters
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Noga
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy*; D011446:Prospective Studies; D011719:Pyrazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib