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

Nordic Myeloma Study Group

Research output: Contribution to journalArticle

188 Citations (Scopus)

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.
Original languageEnglish
Pages (from-to)1405-1412
Number of pages8
JournalBlood
Volume116
Issue number9
Early online date6 May 2010
DOIs
Publication statusPublished - 2 Sep 2010

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Melphalan
Thalidomide
Prednisone
Multiple Myeloma
Placebos
Constipation
Survival
Nervous System
Toxicity
Skin
Quality of Life

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Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. / Nordic Myeloma Study Group.

In: Blood, Vol. 116, No. 9, 02.09.2010, p. 1405-1412.

Research output: Contribution to journalArticle

Nordic Myeloma Study Group. / Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. In: Blood. 2010 ; Vol. 116, No. 9. pp. 1405-1412.
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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.",
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T1 - Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma

AU - Waage, Anders

AU - Gimsing, Peter

AU - Fayers, Peter

AU - Abildgaard, Niels

AU - Ahlberg, Lucia

AU - Björkstrand, Bo

AU - Carlson, Kristina

AU - Dahl, Inger Marie

AU - Forsberg, Karin

AU - Gulbrandsen, Nina

AU - Haukås, Einar

AU - Hjertner, Øyvind

AU - Hjorth, Martin

AU - Karlsson, Torbjörn

AU - Knudsen, Lene Meldgaard

AU - Nielsen, Johan Lanng

AU - Linder, Olle

AU - Mellqvist, Ulf-Henrik

AU - Nesthus, Ingerid

AU - Rolke, Jürgen

AU - Strandberg, Maria

AU - Sørbø, Jon Hjalmar

AU - Wisløff, Finn

AU - Juliusson, Gunnar

AU - Turesson, Ingemar

AU - Nordic Myeloma Study Group

PY - 2010/9/2

Y1 - 2010/9/2

N2 - 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.

AB - 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.

U2 - 10.1182/blood-2009-08-237974

DO - 10.1182/blood-2009-08-237974

M3 - Article

VL - 116

SP - 1405

EP - 1412

JO - Blood

JF - Blood

SN - 0006-4971

IS - 9

ER -