Publication:
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

dc.contributor.authorBeksaç, Meral
dc.contributor.authorHaznedar, Rauf
dc.contributor.authorTuğlular, Tulin Fıratlı
dc.contributor.authorÖzdoğu, Hakan
dc.contributor.authorAydoğdu, İsmet
dc.contributor.authorKonuk, Nahide
dc.contributor.authorSucak, Gülşan
dc.contributor.authorKaygusuz, Işık
dc.contributor.authorKarakuş, Sema
dc.contributor.authorKaya, Emin
dc.contributor.authorGülbaş, Zafer
dc.contributor.authorÖzet, Gülsüm
dc.contributor.authorGöker, Hakan
dc.contributor.authorÜndar, Levent
dc.contributor.buuauthorAli, Rıdvan
dc.contributor.departmentTıp Fakültesi
dc.contributor.departmentHematoloji Ana Bilim Dalı
dc.contributor.scopusid7201813027
dc.date.accessioned2022-03-11T08:29:33Z
dc.date.available2022-03-11T08:29:33Z
dc.date.issued2011-01
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.
dc.description.sponsorshipERKİM İlaç A.Ş.
dc.description.sponsorshipTürk Bilimler Akademisi
dc.identifier.citationBeksaç, M. vd. (2011). "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". European Journal of Haematology, 86(1), 16-22.
dc.identifier.endpage22
dc.identifier.issn0902-4441
dc.identifier.issn1600-0609
dc.identifier.issue1
dc.identifier.pubmed20942865
dc.identifier.scopus2-s2.0-78650159700
dc.identifier.startpage16
dc.identifier.urihttps://doi.org/10.1111/j.1600-0609.2010.01524.x
dc.identifier.urihttps://onlinelibrary.wiley.com/doi/10.1111/j.1600-0609.2010.01524.x
dc.identifier.urihttp://hdl.handle.net/11452/24950
dc.identifier.volume86
dc.identifier.wos000285302200002
dc.indexed.wosSCIE
dc.language.isoen
dc.publisherWiley
dc.relation.collaborationYurt içi
dc.relation.collaborationSanayi
dc.relation.journalEuropean Journal of Haematology
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi
dc.rightsinfo:eu-repo/semantics/closedAccess
dc.subjectHematology
dc.subjectMultiple myeloma
dc.subjectTreatment
dc.subjectMelphalan
dc.subjectPrednisone
dc.subjectThalidomide
dc.subjectPrednisone plus thalidomide
dc.subjectElderly-patients
dc.subject.emtreeAcetylsalicylic acid
dc.subject.emtreeLow molecular weight heparin
dc.subject.emtreeMelphalan
dc.subject.emtreePrednisone
dc.subject.emtreeThalidomide
dc.subject.emtreeWarfarin
dc.subject.emtreeAdd on therapy
dc.subject.emtreeAdult
dc.subject.emtreeAged
dc.subject.emtreeAnticoagulation
dc.subject.emtreeArticle
dc.subject.emtreeCancer mortality
dc.subject.emtreeCancer patient
dc.subject.emtreeCancer survival
dc.subject.emtreeClinical trial
dc.subject.emtreeConstipation
dc.subject.emtreeControlled clinical trial
dc.subject.emtreeControlled study
dc.subject.emtreeCrossover procedure
dc.subject.emtreeDisease free survival
dc.subject.emtreeDrug dose comparison
dc.subject.emtreeDrug dose reduction
dc.subject.emtreeDrug efficacy
dc.subject.emtreeDrug megadose
dc.subject.emtreeDrug response
dc.subject.emtreeDrug safety
dc.subject.emtreeDrug withdrawal
dc.subject.emtreeFebrile neutropenia
dc.subject.emtreeFemale
dc.subject.emtreeHeart disease
dc.subject.emtreeHematologic disease
dc.subject.emtreeHuman
dc.subject.emtreeInfection
dc.subject.emtreeKidney disease
dc.subject.emtreeLow drug dose
dc.subject.emtreeLung embolism
dc.subject.emtreeMajor clinical study
dc.subject.emtreeMale
dc.subject.emtreeMultiple cycle treatment
dc.subject.emtreeMultiple myeloma
dc.subject.emtreeNeuropathy
dc.subject.emtreeOverall survival
dc.subject.emtreePriority journal
dc.subject.emtreeRandomized controlled trial
dc.subject.emtreeSkin manifestation
dc.subject.emtreeThrombosis
dc.subject.emtreeThrombosis prevention
dc.subject.emtreeTreatment duration
dc.subject.emtreeTreatment outcome
dc.subject.emtreeVein thrombosis
dc.subject.meshAge factors
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntineoplastic combined chemotherapy protocols
dc.subject.meshCross-over studies
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshKidney diseases
dc.subject.meshMale
dc.subject.meshMelphalan
dc.subject.meshMiddle aged
dc.subject.meshMultiple myeloma
dc.subject.meshOpportunistic infections
dc.subject.meshPrednisone
dc.subject.meshSurvival analysis
dc.subject.meshThalidomide
dc.subject.meshTreatment outcome
dc.subject.scopusIxazomib; Lenalidomide; Multiple Myeloma
dc.subject.wosHematology
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 Group
dc.typeArticle
dc.wos.quartileQ2
dspace.entity.typePublication
local.contributor.departmentTıp Fakültesi/Hematoloji Ana Bilim Dalı
local.indexed.atScopus
local.indexed.atWOS

Files

License bundle

Now showing 1 - 1 of 1
Placeholder
Name:
license.txt
Size:
1.71 KB
Format:
Item-specific license agreed upon to submission
Description: