title: Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial.
abstract: BACKGROUND
  In multiple myeloma, combination chemotherapy with melphalan plus prednisone is still regarded as the standard of care in elderly patients. We assessed whether the addition of thalidomide to this combination, or reduced-intensity stem cell transplantation, would improve survival.
  
  
  METHODS
  Between May 22, 2000, and Aug 8, 2005, 447 previously untreated patients with multiple myeloma, who were aged between 65 and 75 years, were randomly assigned to receive either melphalan and prednisone (MP; n=196), melphalan and prednisone plus thalidomide (MPT; n=125), or reduced-intensity stem cell transplantation using melphalan 100 mg/m2 (MEL100; n=126). The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00367185.
  
  
  RESULTS
  After a median follow-up of 51.5 months (IQR 34.4-63.2), median overall survival times were 33.2 months (13.8-54.8) for MP, 51.6 months (26.6-not reached) for MPT, and 38.3 months (13.0-61.6) for MEL100. The MPT regimen was associated with a significantly better overall survival than was the MP regimen (hazard ratio 0.59, 95% CI 0.46-0.81, p=0.0006) or MEL100 regimen (0.69, 0.49-0.96, p=0.027). No difference was seen for MEL100 versus MP (0.86, 0.65-1.15, p=0.32).
  
  
  CONCLUSIONS
  The results of our trial provide strong evidence to indicate that the use of thalidomide in combination with melphalan and prednisone should, at present, be the reference treatment for previously untreated elderly patients with multiple myeloma.
authors.affiliation: Service d'Hématologie, Centre Hospitalier Universitaire, Lille, France. t-facon@chru-lille.fr
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Jean Yves
authors.initials: JY
authors.lastname: Mary
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.forename: Lotfi
authors.initials: L
authors.lastname: Benboubker
authors.forename: Michel
authors.initials: M
authors.lastname: Attal
authors.forename: Brigitte
authors.initials: B
authors.lastname: Pegourie
authors.forename: Marc
authors.initials: M
authors.lastname: Renaud
authors.forename: Jean Luc
authors.initials: JL
authors.lastname: Harousseau
authors.forename: Gaëlle
authors.initials: G
authors.lastname: Guillerm
authors.forename: Carine
authors.initials: C
authors.lastname: Chaleteix
authors.forename: Mamoun
authors.initials: M
authors.lastname: Dib
authors.forename: Laurent
authors.initials: L
authors.lastname: Voillat
authors.forename: Hervé
authors.initials: H
authors.lastname: Maisonneuve
authors.forename: Jacques
authors.initials: J
authors.lastname: Troncy
authors.forename: Véronique
authors.initials: V
authors.lastname: Dorvaux
authors.forename: Mathieu
authors.initials: M
authors.lastname: Monconduit
authors.forename: Claude
authors.initials: C
authors.lastname: Martin
authors.forename: Philippe
authors.initials: P
authors.lastname: Casassus
authors.forename: Jérôme
authors.initials: J
authors.lastname: Jaubert
authors.forename: Henry
authors.initials: H
authors.lastname: Jardel
authors.forename: Chantal
authors.initials: C
authors.lastname: Doyen
authors.forename: Brigitte
authors.initials: B
authors.lastname: Kolb
authors.forename: Bruno
authors.initials: B
authors.lastname: Anglaret
authors.forename: Bernard
authors.initials: B
authors.lastname: Grosbois
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Yakoub-Agha
authors.forename: Claire
authors.initials: C
authors.lastname: Mathiot
authors.forename: Hervé
authors.initials: H
authors.lastname: Avet-Loiseau
mesh_terms: D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D011241:Prednisone / Q000008:administration & dosage; D033581:Stem Cell Transplantation; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage
chemical_list: D018906:Antineoplastic Agents, Alkylating; D007166:Immunosuppressive Agents; D013792:Thalidomide; D008558:Melphalan; D011241:Prednisone