title: Bortezomib in combination with intermediate-dose dexamethasone and continuous low-dose oral cyclophosphamide for relapsed multiple myeloma.
abstract: A phase 2 trial was performed to study the combination of bortezomib (VELCADE) with intermediate-dose dexamethasone (DEX), and continuous low-dose oral cyclophosphamide (CY) in patients with relapsed multiple myeloma (MM). Fifty-four patients with advanced MM were enroled to receive eight 3-week treatment cycles with bortezomib 1.3 mg/m(2) on days 1, 4, 8, and 11, followed by three 5-week cycles with bortezomib 1.3 mg/m(2) on days 1, 8, 15, and 22. Within all cycles, DEX 20 mg/d was given orally on the day of bortezomib injection and the day thereafter. In addition, patients received CY continuous oral treatment at a dose of 50 mg/d p.o. once daily. Fifty patients completing at least one treatment cycle were evaluable for response. Complete, partial, and minor responses occurred in 16%, 66% and 8% of patients, respectively; overall response rate 90% (efficacy analysis). Median event-free survival was 12 months, with a median overall survival of 22 months. Adverse events (AE) of grades 3 or 4 occurring in at least 10% of patients comprised leucopenia, infection, herpes zoster, thrombocytopenia, neuropathy and fatigue. Bortezomib combined with DEX and CY is a highly effective treatment for relapsed MM at an acceptable rate of grade 3/4 AE. Antiviral prophylaxis appears to be mandatory.
authors.affiliation: Department of Medicine/Haematology and Oncology, University of Muenster, Muenster, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Kropff
authors.forename: Guido
authors.initials: G
authors.lastname: Bisping
authors.forename: Elke
authors.initials: E
authors.lastname: Schuck
authors.forename: Peter
authors.initials: P
authors.lastname: Liebisch
authors.forename: Nicola
authors.initials: N
authors.lastname: Lang
authors.forename: Markus
authors.initials: M
authors.lastname: Hentrich
authors.forename: Tobias
authors.initials: T
authors.lastname: Dechow
authors.forename: Nicolaus
authors.initials: N
authors.lastname: Kröger
authors.forename: Hans
authors.initials: H
authors.lastname: Salwender
authors.forename: Bernd
authors.initials: B
authors.lastname: Metzner
authors.forename: Orhan
authors.initials: O
authors.lastname: Sezer
authors.forename: Monika
authors.initials: M
authors.lastname: Engelhardt
authors.forename: Hans-Heinrich
authors.initials: HH
authors.lastname: Wolf
authors.forename: Hermann
authors.initials: H
authors.lastname: Einsele
authors.forename: Sarah
authors.initials: S
authors.lastname: Volpert
authors.forename: Achim
authors.initials: A
authors.lastname: Heinecke
authors.forename: Wolfgang E
authors.initials: WE
authors.lastname: Berdel
authors.forename: Joachim
authors.initials: J
authors.lastname: Kienast
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D016009:Chi-Square Distribution; D003520:Cyclophosphamide / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011719:Pyrazines / Q000008:administration & dosage; D012008:Recurrence; D015996:Survival Rate
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone; D003520:Cyclophosphamide