title: Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial.
abstract: We have studied a three-drug combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) on a 28-day cycle in the treatment of newly diagnosed multiple myeloma (MM) patients to assess response and toxicity. The primary endpoint of response was evaluated after four cycles. Thirty-three newly diagnosed, symptomatic patients with MM received bortezomib 1.3 mg/m(2) intravenously on days 1, 4, 8 and 11, cyclophosphamide 300 mg/m(2) orally on days 1, 8, 15 and 22 and dexamethasone 40 mg orally on days 1-4, 9-12 and 17-20 on a 28-day cycle for four cycles. Responses were rapid with a mean 80% decline in the sentinel monoclonal protein at the end of two cycles. The overall intent to treat response rate (>or= partial response) was 88%, with 61% of very good partial response or better (>or=VGPR) and 39% of complete/near complete response (CR/nCR). For the 28 patients who completed all four cycles of therapy, the CR/nCR rate was 46% and VGPR rate was 71%. All patients undergoing stem cell harvest had a successful collection. Twenty-three patients underwent stem cell transplantation (SCT) and are evaluable through day 100 with CR/nCR documented in 70% and >or=VGPR in 74%. In conclusion, CyBorD produces a rapid and profound response in patients with newly diagnosed MM with manageable toxicity.
authors.affiliation: Division of Hematology/Oncology, Mayo Clinic, Scottsdale, AZ 85259, USA. Reeder.craig@mayo.edu
authors.forename: C B
authors.initials: CB
authors.lastname: Reeder
authors.forename: D E
authors.initials: DE
authors.lastname: Reece
authors.forename: V
authors.initials: V
authors.lastname: Kukreti
authors.forename: C
authors.initials: C
authors.lastname: Chen
authors.forename: S
authors.initials: S
authors.lastname: Trudel
authors.forename: J
authors.initials: J
authors.lastname: Hentz
authors.forename: B
authors.initials: B
authors.lastname: Noble
authors.forename: N A
authors.initials: NA
authors.lastname: Pirooz
authors.forename: J E
authors.initials: JE
authors.lastname: Spong
authors.forename: J G
authors.initials: JG
authors.lastname: Piza
authors.forename: V H J
authors.initials: VH
authors.lastname: Zepeda
authors.forename: J R
authors.initials: JR
authors.lastname: Mikhael
authors.forename: J F
authors.initials: JF
authors.lastname: Leis
authors.forename: P L
authors.initials: PL
authors.lastname: Bergsagel
authors.forename: R
authors.initials: R
authors.lastname: Fonseca
authors.forename: A K
authors.initials: AK
authors.lastname: Stewart
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000008:administration & dosage; D000069286:Bortezomib; D003520:Cyclophosphamide / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000601:surgery; D011719:Pyrazines / Q000008:administration & dosage; D033581:Stem Cell Transplantation; D016896:Treatment Outcome
chemical_list: D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone; D003520:Cyclophosphamide