title: Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma.
abstract: In this double-blind, placebo-controlled study, 363 patients with untreated multiple myeloma were randomized to receive either melphalan-prednisone and thalidomide (MPT) or melphalan-prednisone and placebo (MP). The dose of melphalan was 0.25 mg/kg and prednisone was 100 mg given daily for 4 days every 6 weeks until plateau phase. The dose of thalidomide/placebo was escalated to 400 mg daily until plateau phase and thereafter reduced to 200 mg daily until progression. A total of 357 patients were analyzed. Partial response was 34% and 33%, and very good partial response or better was 23% and 7% in the MPT and MP arms, respectively (P < .001). There was no significant difference in progression-free or overall survival, with median survival being 29 months in the MPT arm and 32 months in the MP arm. Most quality of life outcomes improved equally in both arms, apart from constipation, which was markedly increased in the MPT arm. Constipation, neuropathy, nonneuropathy neurologic toxicity, and skin reactions were significantly more frequent in the MPT arm. The number of thromboembolic events was equal in the 2 treatment arms. In conclusion, MPT had a significant antimyeloma effect, but this did not translate into improved survival. This trial was registered at www.clinicaltrials.gov as #NCT00218855.
authors.affiliation: Department of Hematology, St Olavs Hospital, Norwegian University of Science and Technology, Trondheim, Norway. anders.waage@ntnu.no
authors.forename: Anders
authors.initials: A
authors.lastname: Waage
authors.forename: Peter
authors.initials: P
authors.lastname: Gimsing
authors.forename: Peter
authors.initials: P
authors.lastname: Fayers
authors.forename: Niels
authors.initials: N
authors.lastname: Abildgaard
authors.forename: Lucia
authors.initials: L
authors.lastname: Ahlberg
authors.forename: Bo
authors.initials: B
authors.lastname: Björkstrand
authors.forename: Kristina
authors.initials: K
authors.lastname: Carlson
authors.forename: Inger Marie
authors.initials: IM
authors.lastname: Dahl
authors.forename: Karin
authors.initials: K
authors.lastname: Forsberg
authors.forename: Nina
authors.initials: N
authors.lastname: Gulbrandsen
authors.forename: Einar
authors.initials: E
authors.lastname: Haukås
authors.forename: Oyvind
authors.initials: O
authors.lastname: Hjertner
authors.forename: Martin
authors.initials: M
authors.lastname: Hjorth
authors.forename: Torbjörn
authors.initials: T
authors.lastname: Karlsson
authors.forename: Lene Meldgaard
authors.initials: LM
authors.lastname: Knudsen
authors.forename: Johan Lanng
authors.initials: JL
authors.lastname: Nielsen
authors.forename: Olle
authors.initials: O
authors.lastname: Linder
authors.forename: Ulf-Henrik
authors.initials: UH
authors.lastname: Mellqvist
authors.forename: Ingerid
authors.initials: I
authors.lastname: Nesthus
authors.forename: Jürgen
authors.initials: J
authors.lastname: Rolke
authors.forename: Maria
authors.initials: M
authors.lastname: Strandberg
authors.forename: Jon Hjalmar
authors.initials: JH
authors.lastname: Sørbø
authors.forename: Finn
authors.initials: F
authors.lastname: Wisløff
authors.forename: Gunnar
authors.initials: G
authors.lastname: Juliusson
authors.forename: Ingemar
authors.initials: I
authors.lastname: Turesson
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D010919:Placebos; D011241:Prednisone / Q000008:administration & dosage; D012074:Remission Induction; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D013792:Thalidomide; D008558:Melphalan; D011241:Prednisone