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Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma
Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
Department of Hematology, Rigshospitalet and University of Copenhagen.
Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.
Department of Hematology, Odense University Hospital, Odense, Denmark.
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2010 (English)In: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 116, no 9, 1405-1412 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2010. Vol. 116, no 9, 1405-1412 p.
Identifiers
URN: urn:nbn:se:umu:diva-36855DOI: 10.1182/blood-2009-08-237974PubMedID: 20448107OAI: oai:DiVA.org:umu-36855DiVA: diva2:356464
Available from: 2010-10-12 Created: 2010-10-12 Last updated: 2017-12-12Bibliographically approved

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