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Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma

Waage, Anders; Gimsing, Peter; Fayers, Peter; Abildgaard, Niels; Ahlberg, Lucia; Bjorkstrand, Bo; Carlson, Kristina; Dahl, Inger Marie; Forsberg, Karin and Gulbrandsen, Nina, et al. (2010) In Blood 116(9). p.1405-1412
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... (More)
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, non-neuropathy 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. (Blood. 2010;116(9):1405-1412) (Less)
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Blood
volume
116
issue
9
pages
1405 - 1412
publisher
American Society of Hematology
external identifiers
  • wos:000281572700007
  • scopus:77956599686
ISSN
1528-0020
DOI
10.1182/blood-2009-08-237974
language
English
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yes
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ff5230b1-5218-4eba-a93d-9e31032ed581 (old id 1697871)
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2010-10-22 12:50:20
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2018-11-21 19:38:32
@article{ff5230b1-5218-4eba-a93d-9e31032ed581,
  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 &lt; .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, non-neuropathy 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. (Blood. 2010;116(9):1405-1412)},
  author       = {Waage, Anders and Gimsing, Peter and Fayers, Peter and Abildgaard, Niels and Ahlberg, Lucia and Bjorkstrand, Bo and Carlson, Kristina and Dahl, Inger Marie and Forsberg, Karin and Gulbrandsen, Nina and Haukas, Einar and Hjertner, Oyvind and Hjorth, Martin and Karlsson, Torbjorn and Knudsen, Lene Meldgaard and Nielsen, Johan Lanng and Linder, Olle and Mellqvist, Ulf-Henrik and Nesthus, Ingerid and Rolke, Jurgen and Strandberg, Maria and Sorbo, Jon Hjalmar and Wisloff, Finn and Juliusson, Gunnar and Turesson, Ingemar},
  issn         = {1528-0020},
  language     = {eng},
  number       = {9},
  pages        = {1405--1412},
  publisher    = {American Society of Hematology},
  series       = {Blood},
  title        = {Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma},
  url          = {http://dx.doi.org/10.1182/blood-2009-08-237974},
  volume       = {116},
  year         = {2010},
}