title: Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma.
abstract: BACKGROUND
  Lenalidomide is a structural analogue of thalidomide with similar but more potent biologic activity. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide plus dexamethasone in the treatment of relapsed or refractory multiple myeloma.
  
  
  METHODS
  Of 351 patients who had received at least one previous antimyeloma therapy, 176 were randomly assigned to receive 25 mg of oral lenalidomide and 175 to receive placebo on days 1 to 21 of a 28-day cycle. In addition, all patients received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles and subsequently, after the fourth cycle, only on days 1 to 4. Patients continued in the study until the occurrence of disease progression or unacceptable toxic effects. The primary end point was time to progression.
  
  
  RESULTS
  The time to progression was significantly longer in the patients who received lenalidomide plus dexamethasone (lenalidomide group) than in those who received placebo plus dexamethasone (placebo group) (median, 11.3 months vs. 4.7 months; P<0.001). A complete or partial response occurred in 106 patients in the lenalidomide group (60.2%) and in 42 patients in the placebo group (24.0%, P<0.001), with a complete response in 15.9% and 3.4% of patients, respectively (P<0.001). Overall survival was significantly improved in the lenalidomide group (hazard ratio for death, 0.66; P=0.03). Grade 3 or 4 adverse events that occurred in more than 10% of patients in the lenalidomide group were neutropenia (29.5%, vs. 2.3% in the placebo group), thrombocytopenia (11.4% vs. 5.7%), and venous thromboembolism (11.4% vs. 4.6%).
  
  
  CONCLUSIONS
  Lenalidomide plus dexamethasone is more effective than high-dose dexamethasone alone in relapsed or refractory multiple myeloma. (ClinicalTrials.gov number, NCT00424047 [ClinicalTrials.gov].).
authors.affiliation: University of Athens School of Medicine, Athens, Greece. mdimop@med.uoa.gr
authors.forename: Meletios
authors.initials: M
authors.lastname: Dimopoulos
authors.forename: Andrew
authors.initials: A
authors.lastname: Spencer
authors.forename: Michael
authors.initials: M
authors.lastname: Attal
authors.forename: H Miles
authors.initials: HM
authors.lastname: Prince
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Harousseau
authors.forename: Anna
authors.initials: A
authors.lastname: Dmoszynska
authors.forename: Jesus
authors.initials: J
authors.lastname: San Miguel
authors.forename: Andrzej
authors.initials: A
authors.lastname: Hellmann
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Robin
authors.initials: R
authors.lastname: Foà
authors.forename: Alessandro
authors.initials: A
authors.lastname: Corso
authors.forename: Zvenyslava
authors.initials: Z
authors.lastname: Masliak
authors.forename: Marta
authors.initials: M
authors.lastname: Olesnyckyj
authors.forename: Zhinuan
authors.initials: Z
authors.lastname: Yu
authors.forename: John
authors.initials: J
authors.lastname: Patin
authors.forename: Jerome B
authors.initials: JB
authors.lastname: Zeldis
authors.forename: Robert D
authors.initials: RD
authors.lastname: Knight
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D012008:Recurrence; D016019:Survival Analysis; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D005938:Glucocorticoids; D007155:Immunologic Factors; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide