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.author | Beksaç, Meral | |
dc.contributor.author | Haznedar, Rauf | |
dc.contributor.author | Tuğlular, Tulin Fıratlı | |
dc.contributor.author | Özdoğu, Hakan | |
dc.contributor.author | Aydoğdu, İsmet | |
dc.contributor.author | Konuk, Nahide | |
dc.contributor.author | Sucak, Gülşan | |
dc.contributor.author | Kaygusuz, Işık | |
dc.contributor.author | Karakuş, Sema | |
dc.contributor.author | Kaya, Emin | |
dc.contributor.author | Gülbaş, Zafer | |
dc.contributor.author | Özet, Gülsüm | |
dc.contributor.author | Göker, Hakan | |
dc.contributor.author | Ündar, Levent | |
dc.contributor.buuauthor | Ali, Rıdvan | |
dc.contributor.department | Tıp Fakültesi | |
dc.contributor.department | Hematoloji Ana Bilim Dalı | |
dc.contributor.scopusid | 7201813027 | |
dc.date.accessioned | 2022-03-11T08:29:33Z | |
dc.date.available | 2022-03-11T08:29:33Z | |
dc.date.issued | 2011-01 | |
dc.description.abstract | The 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.sponsorship | ERKİM İlaç A.Ş. | |
dc.description.sponsorship | Türk Bilimler Akademisi | |
dc.identifier.citation | Beksaç, 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.endpage | 22 | |
dc.identifier.issn | 0902-4441 | |
dc.identifier.issn | 1600-0609 | |
dc.identifier.issue | 1 | |
dc.identifier.pubmed | 20942865 | |
dc.identifier.scopus | 2-s2.0-78650159700 | |
dc.identifier.startpage | 16 | |
dc.identifier.uri | https://doi.org/10.1111/j.1600-0609.2010.01524.x | |
dc.identifier.uri | https://onlinelibrary.wiley.com/doi/10.1111/j.1600-0609.2010.01524.x | |
dc.identifier.uri | http://hdl.handle.net/11452/24950 | |
dc.identifier.volume | 86 | |
dc.identifier.wos | 000285302200002 | |
dc.indexed.wos | SCIE | |
dc.language.iso | en | |
dc.publisher | Wiley | |
dc.relation.collaboration | Yurt içi | |
dc.relation.collaboration | Sanayi | |
dc.relation.journal | European Journal of Haematology | |
dc.relation.publicationcategory | Makale - Uluslararası Hakemli Dergi | |
dc.rights | info:eu-repo/semantics/closedAccess | |
dc.subject | Hematology | |
dc.subject | Multiple myeloma | |
dc.subject | Treatment | |
dc.subject | Melphalan | |
dc.subject | Prednisone | |
dc.subject | Thalidomide | |
dc.subject | Prednisone plus thalidomide | |
dc.subject | Elderly-patients | |
dc.subject.emtree | Acetylsalicylic acid | |
dc.subject.emtree | Low molecular weight heparin | |
dc.subject.emtree | Melphalan | |
dc.subject.emtree | Prednisone | |
dc.subject.emtree | Thalidomide | |
dc.subject.emtree | Warfarin | |
dc.subject.emtree | Add on therapy | |
dc.subject.emtree | Adult | |
dc.subject.emtree | Aged | |
dc.subject.emtree | Anticoagulation | |
dc.subject.emtree | Article | |
dc.subject.emtree | Cancer mortality | |
dc.subject.emtree | Cancer patient | |
dc.subject.emtree | Cancer survival | |
dc.subject.emtree | Clinical trial | |
dc.subject.emtree | Constipation | |
dc.subject.emtree | Controlled clinical trial | |
dc.subject.emtree | Controlled study | |
dc.subject.emtree | Crossover procedure | |
dc.subject.emtree | Disease free survival | |
dc.subject.emtree | Drug dose comparison | |
dc.subject.emtree | Drug dose reduction | |
dc.subject.emtree | Drug efficacy | |
dc.subject.emtree | Drug megadose | |
dc.subject.emtree | Drug response | |
dc.subject.emtree | Drug safety | |
dc.subject.emtree | Drug withdrawal | |
dc.subject.emtree | Febrile neutropenia | |
dc.subject.emtree | Female | |
dc.subject.emtree | Heart disease | |
dc.subject.emtree | Hematologic disease | |
dc.subject.emtree | Human | |
dc.subject.emtree | Infection | |
dc.subject.emtree | Kidney disease | |
dc.subject.emtree | Low drug dose | |
dc.subject.emtree | Lung embolism | |
dc.subject.emtree | Major clinical study | |
dc.subject.emtree | Male | |
dc.subject.emtree | Multiple cycle treatment | |
dc.subject.emtree | Multiple myeloma | |
dc.subject.emtree | Neuropathy | |
dc.subject.emtree | Overall survival | |
dc.subject.emtree | Priority journal | |
dc.subject.emtree | Randomized controlled trial | |
dc.subject.emtree | Skin manifestation | |
dc.subject.emtree | Thrombosis | |
dc.subject.emtree | Thrombosis prevention | |
dc.subject.emtree | Treatment duration | |
dc.subject.emtree | Treatment outcome | |
dc.subject.emtree | Vein thrombosis | |
dc.subject.mesh | Age factors | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Aged, 80 and over | |
dc.subject.mesh | Antineoplastic combined chemotherapy protocols | |
dc.subject.mesh | Cross-over studies | |
dc.subject.mesh | Female | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Kidney diseases | |
dc.subject.mesh | Male | |
dc.subject.mesh | Melphalan | |
dc.subject.mesh | Middle aged | |
dc.subject.mesh | Multiple myeloma | |
dc.subject.mesh | Opportunistic infections | |
dc.subject.mesh | Prednisone | |
dc.subject.mesh | Survival analysis | |
dc.subject.mesh | Thalidomide | |
dc.subject.mesh | Treatment outcome | |
dc.subject.scopus | Ixazomib; Lenalidomide; Multiple Myeloma | |
dc.subject.wos | Hematology | |
dc.title | 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.type | Article | |
dc.wos.quartile | Q2 | |
dspace.entity.type | Publication | |
local.contributor.department | Tıp Fakültesi/Hematoloji Ana Bilim Dalı | |
local.indexed.at | Scopus | |
local.indexed.at | WOS |
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