title: Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232).
abstract: The Southwest Oncology Group conducted a randomized trial comparing lenalidomide (LEN) plus dexamethasone (DEX; n = 97) to placebo (PLC) plus DEX (n = 95) in newly diagnosed myeloma. Three 35-day induction cycles applied DEX 40 mg/day on days 1 to 4, 9 to 12, and 17 to 20 together with LEN 25 mg/day for 28 days or PLC. Monthly maintenance used DEX 40 mg/day on days 1 to 4 and 15 to 18 along with LEN 25 mg/day for 21 days or PLC. Crossover from PLC-DEX to LEN-DEX was encouraged on progression. One-year progression-free survival, overall response rate, and very good partial response rate were superior with LEN-DEX (78% vs 52%, P = .002; 78% vs 48%, P < .001; 63% vs 16%, P < .001), whereas 1-year overall survival was similar (94% vs 88%; P = .25). Toxicities were more pronounced with LEN-DEX (neutropenia grade 3 or 4: 21% vs 5%, P < .001; thromboembolic events despite aspirin prophylaxis: 23.5% [initial LEN-DEX or crossover] vs 5%; P < .001). This trial was registered at www.clinicaltrials.gov as #NCT00064038.
authors.affiliation: Division of Hematology/Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI 48201, USA. zonderj@karmanos.org
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Zonder
authors.forename: John
authors.initials: J
authors.lastname: Crowley
authors.forename: Mohamad A
authors.initials: MA
authors.lastname: Hussein
authors.forename: Vanessa
authors.initials: V
authors.lastname: Bolejack
authors.forename: Dennis F
authors.initials: DF
authors.lastname: Moore
authors.forename: Brock F
authors.initials: BF
authors.lastname: Whittenberger
authors.forename: Muneer H
authors.initials: MH
authors.lastname: Abidi
authors.forename: Brian G M
authors.initials: BG
authors.lastname: Durie
authors.forename: Bart
authors.initials: B
authors.lastname: Barlogie
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D012074:Remission Induction; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide