Addition of thalidomide to oral melphalan/prednisone in patients with multiple myeloma not eligible for transplantation: results of a randomized trial from the Turkish Myeloma Study Group

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dc.authoridBeksac, Meral/0000-0003-1797-8657
dc.authoridÖZDOĞU, HAKAN/0000-0002-8902-1283
dc.authoridKAYA, Emin/0000-0001-8605-8497
dc.authoridAladag, Elifcan/0000-0002-1206-9908
dc.authoridKARAKUS, SEMA/0000-0001-7615-4581
dc.authorwosidBeksac, Meral/D-6411-2013
dc.authorwosidÖZDOĞU, HAKAN/AAD-5542-2021
dc.authorwosidKAYA, Emin/W-2951-2017
dc.authorwosidAladag, Elifcan/ABA-4185-2020
dc.authorwosidKARAKUS, SEMA/W-9092-2019
dc.contributor.authorBeksac, Meral
dc.contributor.authorHaznedar, Rauf
dc.contributor.authorFiratli-Tuglular, Tulin
dc.contributor.authorOzdogu, Hakan
dc.contributor.authorAydogdu, Ismet
dc.contributor.authorKonuk, Nahide
dc.contributor.authorSucak, Gulsan
dc.date.accessioned2024-08-04T20:32:40Z
dc.date.available2024-08-04T20:32:40Z
dc.date.issued2011
dc.departmentİnönü Üniversitesien_US
dc.description.abstractThe combination of melphalan-prednisone-thalidomide (MPT) has been investigated in several clinical studies that differed significantly with regard to patient characteristics and treatment schedules. This prospective trial differs from previous melphalan-prednisone (MP) vs. MPT trials by treatment dosing, duration, routine anticoagulation, and permission for a crossover. Newly diagnosed patients with multiple myeloma (MM) (n = 122) aged greater than 55 yr, not eligible for transplantation were randomized to receive 8 cycles of M (9 mg/m2/d) and P (60 mg/m2/d) for 4 d every 6 wk (n = 62) or MP and thalidomide (100 mg/d) continuously (n = 60). Primary endpoint was treatment response and toxicities following 4 and 8 cycles of therapy. Secondary endpoints were disease-free (DFS) and overall survival (OS). Overall, MPT-treated patients were younger (median 69 yr vs. 72 yr; P = 0.016) and had a higher incidence of renal impairment (RI, 19% vs. 7%, respectively; P = 0.057). After 4 cycles of treatment (n = 115), there were more partial responses or better in the MPT arm than in the MP arm (57.9% vs. 37.5%; P = 0.030). However, DFS and OS were not significantly different between the arms after a median of 23 months follow-up (median OS 26.0 vs. 28.0 months, P = 0.655; DFS 21.0 vs. 14.0 months, P = 0.342, respectively). Crossover to MPT was required in 11 patients, 57% of whom responded to treatment. A higher rate of grade 3-4 infections was observed in the MPT arm compared with the MP arm (22.4% vs. 7.0%; P = 0.033). However, none of these infections were associated with febrile neutropenia. Death within the first 3 months was observed more frequently in the MP arm (n = 8, 14.0%) than in the MPT arm (n = 2, 3.4%; P = 0.053). Long-term discontinuation and dose reduction rates were also analyzed (MPT: 15.5% vs. MP: 5.3%; P = 0.072). Although patients treated with MPT were relatively younger and had more frequent RI, better responses and less early mortality were observed in all age groups despite more frequent discontinuation. This study is registered at http://www.clinicaltrials.gov as #NCT00934154.en_US
dc.description.sponsorshipTurkish Academy of Sciencesen_US
dc.description.sponsorshipAuthors thank ERKIM Ilac AS for their generous contribution manifested as drug supply and coverage of the CRO, insurance and logistic costs throughout the study period. In addition, this study was partially supported by the Turkish Academy of Sciences.en_US
dc.identifier.doi10.1111/j.1600-0609.2010.01524.x
dc.identifier.endpage22en_US
dc.identifier.issn0902-4441
dc.identifier.issn1600-0609
dc.identifier.issue1en_US
dc.identifier.pmid20942865en_US
dc.identifier.scopus2-s2.0-78650159700en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage16en_US
dc.identifier.urihttps://doi.org/10.1111/j.1600-0609.2010.01524.x
dc.identifier.urihttps://hdl.handle.net/11616/95215
dc.identifier.volume86en_US
dc.identifier.wosWOS:000285302200002en_US
dc.identifier.wosqualityQ2en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.ispartofEuropean Journal of Haematologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectmultiple myelomaen_US
dc.subjecttreatmenten_US
dc.subjectmelphalanen_US
dc.subjectprednisoneen_US
dc.subjectthalidomideen_US
dc.titleAddition of thalidomide to oral melphalan/prednisone in patients with multiple myeloma not eligible for transplantation: results of a randomized trial from the Turkish Myeloma Study Groupen_US
dc.typeArticleen_US

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