000125464 001__ 125464
000125464 005__ 20240228143308.0
000125464 0247_ $$2doi$$a10.1186/s12885-016-2321-2
000125464 0247_ $$2pmid$$apmid:27114074
000125464 0247_ $$2pmc$$apmc:PMC4845347
000125464 0247_ $$2altmetric$$aaltmetric:6952810
000125464 037__ $$aDKFZ-2017-01590
000125464 041__ $$aeng
000125464 082__ $$a610
000125464 1001_ $$aBaertsch, Marc-Andrea$$b0
000125464 245__ $$aRationale and design of the German-Speaking Myeloma Multicenter Group (GMMG) trial ReLApsE: a randomized, open, multicenter phase III trial of lenalidomide/dexamethasone versus lenalidomide/dexamethasone plus subsequent autologous stem cell transplantation and lenalidomide maintenance in patients with relapsed multiple myeloma.
000125464 260__ $$aLondon$$bBioMed Central$$c2016
000125464 3367_ $$2DRIVER$$aarticle
000125464 3367_ $$2DataCite$$aOutput Types/Journal article
000125464 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1524211694_4838
000125464 3367_ $$2BibTeX$$aARTICLE
000125464 3367_ $$2ORCID$$aJOURNAL_ARTICLE
000125464 3367_ $$00$$2EndNote$$aJournal Article
000125464 520__ $$aDespite novel therapeutic agents, most multiple myeloma (MM) patients eventually relapse. Two large phase III trials have shown significantly improved response rates (RR) of lenalidomide/dexamethasone compared with placebo/dexamethasone in relapsed MM (RMM) patients. These results have led to the approval of lenalidomide for RMM patients and lenalidomide/dexamethasone has since become a widely accepted second-line treatment. Furthermore, in RMM patients consolidation with high-dose chemotherapy plus autologous stem cell transplantation has been shown to significantly increase progression free survival (PFS) as compared to cyclophosphamide in a phase III trial. The randomized prospective ReLApsE trial is designed to evaluate PFS after lenalidomide/dexamethasone induction, high-dose chemotherapy consolidation plus autologous stem cell transplantation and lenalidomide maintenance compared with the well-established lenalidomide/dexamethasone regimen in RMM patients.ReLApsE is a randomized, open, multicenter phase III trial in a planned study population of 282 RMM patients. All patients receive three lenalidomide/dexamethasone cycles and--in absence of available stem cells from earlier harvesting--undergo peripheral blood stem cell mobilization and harvesting. Subsequently, patients in arm A continue on consecutive lenalidomide/dexamethasone cycles, patients in arm B undergo high dose chemotherapy plus autologous stem cell transplantation followed by lenalidomide maintenance until discontinuation criteria are met. Therapeutic response is evaluated after the 3(rd) (arm A + B) and the 5(th) lenalidomide/dexamethasone cycle (arm A) or 2 months after autologous stem cell transplantation (arm B) and every 3 months thereafter (arm A + B). After finishing the study treatment, patients are followed up for survival and subsequent myeloma therapies. The expected trial duration is 6.25 years from first patient in to last patient out. The primary endpoint is PFS, secondary endpoints include overall survival (OS), RR, time to best response and the influence of early versus late salvage high dose chemotherapy plus autologous stem cell transplantation on OS.This phase III trial is designed to evaluate whether high dose chemotherapy plus autologous stem cell transplantation and lenalidomide maintenance after lenalidomide/dexamethasone induction improves PFS compared with the well-established continued lenalidomide/dexamethasone regimen in RMM patients.ISRCTN16345835 (date of registration 2010-08-24).
000125464 536__ $$0G:(DE-HGF)POF3-317$$a317 - Translational cancer research (POF3-317)$$cPOF3-317$$fPOF III$$x0
000125464 588__ $$aDataset connected to CrossRef, PubMed,
000125464 650_7 $$04Z8R6ORS6L$$2NLM Chemicals$$aThalidomide
000125464 650_7 $$07S5I7G3JQL$$2NLM Chemicals$$aDexamethasone
000125464 650_7 $$0F0P408N6V4$$2NLM Chemicals$$alenalidomide
000125464 7001_ $$aSchlenzka, Jana$$b1
000125464 7001_ $$aMai, Elias K$$b2
000125464 7001_ $$aMerz, Maximilian$$b3
000125464 7001_ $$aHillengaß, Jens$$b4
000125464 7001_ $$0P:(DE-HGF)0$$aRaab, Marc S$$b5
000125464 7001_ $$aHose, Dirk$$b6
000125464 7001_ $$aWuchter, Patrick$$b7
000125464 7001_ $$aHo, Anthony D$$b8
000125464 7001_ $$aJauch, Anna$$b9
000125464 7001_ $$0P:(DE-He78)743a4a82daab55306a2c88b9f6bf8c2f$$aHielscher, Thomas$$b10$$udkfz
000125464 7001_ $$0P:(DE-He78)a9f6104e5c2c26345dcb242e6bdcb2b2$$aKunz, Christina$$b11$$udkfz
000125464 7001_ $$aLuntz, Steffen$$b12
000125464 7001_ $$aKlein, Stefan$$b13
000125464 7001_ $$aSchmidt-Wolf, Ingo G H$$b14
000125464 7001_ $$aGoerner, Martin$$b15
000125464 7001_ $$aSchmidt-Hieber, Martin$$b16
000125464 7001_ $$aReimer, Peter$$b17
000125464 7001_ $$aGraeven, Ullrich$$b18
000125464 7001_ $$aFenk, Roland$$b19
000125464 7001_ $$aSalwender, Hans$$b20
000125464 7001_ $$aScheid, Christof$$b21
000125464 7001_ $$aNogai, Axel$$b22
000125464 7001_ $$aHaenel, Mathias$$b23
000125464 7001_ $$aLindemann, Hans W$$b24
000125464 7001_ $$aMartin, Hans$$b25
000125464 7001_ $$aNoppeney, Richard$$b26
000125464 7001_ $$aWeisel, Katja$$b27
000125464 7001_ $$aGoldschmidt, Hartmut$$b28
000125464 773__ $$0PERI:(DE-600)2041352-X$$a10.1186/s12885-016-2321-2$$gVol. 16, no. 1, p. 290$$n1$$p290$$tBMC cancer$$v16$$x1471-2407$$y2016
000125464 909CO $$ooai:inrepo02.dkfz.de:125464$$pVDB
000125464 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-HGF)0$$aDeutsches Krebsforschungszentrum$$b5$$kDKFZ
000125464 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)743a4a82daab55306a2c88b9f6bf8c2f$$aDeutsches Krebsforschungszentrum$$b10$$kDKFZ
000125464 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)a9f6104e5c2c26345dcb242e6bdcb2b2$$aDeutsches Krebsforschungszentrum$$b11$$kDKFZ
000125464 9131_ $$0G:(DE-HGF)POF3-317$$1G:(DE-HGF)POF3-310$$2G:(DE-HGF)POF3-300$$3G:(DE-HGF)POF3$$4G:(DE-HGF)POF$$aDE-HGF$$bGesundheit$$lKrebsforschung$$vTranslational cancer research$$x0
000125464 9141_ $$y2016
000125464 915__ $$0StatID:(DE-HGF)0100$$2StatID$$aJCR$$bBMC CANCER : 2015
000125464 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS
000125464 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline
000125464 915__ $$0StatID:(DE-HGF)0310$$2StatID$$aDBCoverage$$bNCBI Molecular Biology Database
000125464 915__ $$0StatID:(DE-HGF)0501$$2StatID$$aDBCoverage$$bDOAJ Seal
000125464 915__ $$0StatID:(DE-HGF)0500$$2StatID$$aDBCoverage$$bDOAJ
000125464 915__ $$0LIC:(DE-HGF)CCBYNV$$2V:(DE-HGF)$$aCreative Commons Attribution CC BY (No Version)$$bDOAJ
000125464 915__ $$0StatID:(DE-HGF)0600$$2StatID$$aDBCoverage$$bEbsco Academic Search
000125464 915__ $$0StatID:(DE-HGF)0030$$2StatID$$aPeer Review$$bASC
000125464 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bThomson Reuters Master Journal List
000125464 915__ $$0StatID:(DE-HGF)0111$$2StatID$$aWoS$$bScience Citation Index Expanded
000125464 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection
000125464 915__ $$0StatID:(DE-HGF)1110$$2StatID$$aDBCoverage$$bCurrent Contents - Clinical Medicine
000125464 915__ $$0StatID:(DE-HGF)9900$$2StatID$$aIF < 5
000125464 9201_ $$0I:(DE-He78)G330-20160331$$kG330$$lKKE Molekulare Hämatologie/Onkologie$$x0
000125464 9201_ $$0I:(DE-He78)C060-20160331$$kC060$$lBiostatistik$$x1
000125464 980__ $$ajournal
000125464 980__ $$aVDB
000125464 980__ $$aI:(DE-He78)G330-20160331
000125464 980__ $$aI:(DE-He78)C060-20160331
000125464 980__ $$aUNRESTRICTED