title: Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma.
abstract: We report the results of a phase 2 trial using lenalidomide plus dexamethasone (Rev/Dex) as initial therapy for myeloma. Thirty-four patients were enrolled. Lenalidomide was given orally 25 mg daily on days 1 to 21 of a 28-day cycle. Dexamethasone was given orally 40 mg daily on days 1 to 4, 9 to 12, and 17 to 20 of each cycle. Objective response was defined as a decrease in serum monoclonal protein level by 50% or greater and a decrease in urine M protein level by at least 90% or to a level less than 200 mg/24 hours, confirmed by 2 consecutive determinations at least 4 weeks apart. Thirty-one of 34 patients achieved an objective response, including 2 (6%) achieving complete response (CR) and 11 (32%) meeting criteria for both very good partial response and near complete response, resulting in an overall objective response rate of 91%. Of the 3 remaining patients not achieving an objective response, 2 had minor response (MR) and one had stable disease. Forty-seven percent of patients experienced grade III or higher nonhematologic toxicity, most commonly fatigue (15%), muscle weakness (6%), anxiety (6%), pneumonitis (6%), and rash (6%). Rev/Dex is a highly active regimen with manageable side effects in the treatment of newly diagnosed myeloma.
authors.affiliation: Division of Hematology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. rajks@mayo.edu
authors.forename: S Vincent
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: Suzanne R
authors.initials: SR
authors.lastname: Hayman
authors.forename: Martha Q
authors.initials: MQ
authors.lastname: Lacy
authors.forename: Angela
authors.initials: A
authors.lastname: Dispenzieri
authors.forename: Susan M
authors.initials: SM
authors.lastname: Geyer
authors.forename: Brian
authors.initials: B
authors.lastname: Kabat
authors.forename: Steven R
authors.initials: SR
authors.lastname: Zeldenrust
authors.forename: Shaji
authors.initials: S
authors.lastname: Kumar
authors.forename: Philip R
authors.initials: PR
authors.lastname: Greipp
authors.forename: Rafael
authors.initials: R
authors.lastname: Fonseca
authors.forename: John A
authors.initials: JA
authors.lastname: Lust
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Russell
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kyle
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
authors.forename: Morie A
authors.initials: MA
authors.lastname: Gertz
mesh_terms: D000328:Adult; D000368:Aged; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006403:Hematologic Tests; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy*; D015996:Survival Rate; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide