title: Lenalidomide maintenance after stem-cell transplantation for multiple myeloma.
abstract: BACKGROUND
  High-dose chemotherapy with autologous stem-cell transplantation is a standard treatment for young patients with multiple myeloma. Residual disease is almost always present after transplantation and is responsible for relapse. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide maintenance therapy after transplantation.
  
  
  METHODS
  We randomly assigned 614 patients younger than 65 years of age who had nonprogressive disease after first-line transplantation to maintenance treatment with either lenalidomide (10 mg per day for the first 3 months, increased to 15 mg if tolerated) or placebo until relapse. The primary end point was progression-free survival.
  
  
  RESULTS
  Lenalidomide maintenance therapy improved median progression-free survival (41 months, vs. 23 months with placebo; hazard ratio, 0.50; P<0.001). This benefit was observed across all patient subgroups, including those based on the β(2)-microglobulin level, cytogenetic profile, and response after transplantation. With a median follow-up period of 45 months, more than 70% of patients in both groups were alive at 4 years. The rates of grade 3 or 4 peripheral neuropathy were similar in the two groups. The incidence of second primary cancers was 3.1 per 100 patient-years in the lenalidomide group versus 1.2 per 100 patient-years in the placebo group (P=0.002). Median event-free survival (with events that included second primary cancers) was significantly improved with lenalidomide (40 months, vs. 23 months with placebo; P<0.001).
  
  
  CONCLUSIONS
  Lenalidomide maintenance after transplantation significantly prolonged progression-free and event-free survival among patients with multiple myeloma. Four years after randomization, overall survival was similar in the two study groups. (Funded by the Programme Hospitalier de Recherche Clinique and others; ClinicalTrials.gov number, NCT00430365.).
authors.affiliation: Department of Hematology, Hôpital Purpan, Toulouse, France. attal.m@chu-toulouse.fr
authors.forename: Michel
authors.initials: M
authors.lastname: Attal
authors.forename: Valerie
authors.initials: V
authors.lastname: Lauwers-Cances
authors.forename: Gerald
authors.initials: G
authors.lastname: Marit
authors.forename: Denis
authors.initials: D
authors.lastname: Caillot
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Stoppa
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.forename: Lofti
authors.initials: L
authors.lastname: Benboubker
authors.forename: Laurent
authors.initials: L
authors.lastname: Garderet
authors.forename: Olivier
authors.initials: O
authors.lastname: Decaux
authors.forename: Serge
authors.initials: S
authors.lastname: Leyvraz
authors.forename: Marie-Christiane
authors.initials: MC
authors.lastname: Vekemans
authors.forename: Laurent
authors.initials: L
authors.lastname: Voillat
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Brigitte
authors.initials: B
authors.lastname: Pegourie
authors.forename: Charles
authors.initials: C
authors.lastname: Dumontet
authors.forename: Murielle
authors.initials: M
authors.lastname: Roussel
authors.forename: Xavier
authors.initials: X
authors.lastname: Leleu
authors.forename: Claire
authors.initials: C
authors.lastname: Mathiot
authors.forename: Catherine
authors.initials: C
authors.lastname: Payen
authors.forename: Hervé
authors.initials: H
authors.lastname: Avet-Loiseau
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Harousseau
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D016609:Neoplasms, Second Primary / Q000453:epidemiology; D033581:Stem Cell Transplantation; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide