References
- PalumboAAndersonKMultiple myelomaN Engl J Med20113641046106021410373
- RolligCKnopSBornhauserMMultiple myelomaLancet20153852197220825540889
- SiegelRLMillerKDJemalACancer statistics, 2015CA Cancer J Clin20156552925559415
- International Agency for Research on CancerGLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012 Available from: http://globocan.iarc.fr/Default.aspx2012Accessed December 13, 2016
- AndersonKCOncogenomics to target myeloma in the bone marrow microenvironmentClin Cancer Res2011171225123321411438
- MoreauPMassziTGrzaskoNOral ixazomib, lenalidomide, and dexamethasone for multiple myelomaN Engl J Med20163741621163427119237
- KumarSKDispenzieriALacyMQContinued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patientsLeukemia2014281122112824157580
- KumarSKTherneauTMGertzMAClinical course of patients with relapsed multiple myelomaMayo Clin Proc20047986787415244382
- Martinez-LopezJLahuertaJJPepinFPrognostic value of deep sequencing method for minimal residual disease detection in multiple myelomaBlood20141233073307924646471
- MunshiNCAndersonKCMinimal residual disease in multiple myelomaJ Clin Oncol2013312523252623733782
- Cid RuzafaJMerinopoulouEBaggaleyRFPatient population with multiple myeloma and transitions across different lines of therapy in the USA: an epidemiologic modelPharmacoepidemiol Drug Saf201625887187927476979
- SongXCongZWilsonKReal-world treatment patterns, comorbidities, and disease-related complications in patients with multiple myeloma in the United StatesCurr Med Res Opin2016329510326488820
- WillenbacherEWegerRRochauUSiebertUWillenbacherWReal-world use of 3rd line therapy for multiple myeloma in Austria: an Austrian Myeloma Registry (AMR) analysis of the therapeutic landscape and clinical outcomes prior to the use of next generation myeloma therapeuticsPLoS One201611e014738126937956
- DimopoulosMARichardsonPGMoreauPAndersonKCCurrent treatment landscape for relapsed and/or refractory multiple myelomaNat Rev Clin Oncol201512425425421279
- Avet-LoiseauHAttalMMoreauPGenetic abnormalities and survival in multiple myeloma: the experience of the Intergroupe Francophone du MyelomeBlood20071093489349517209057
- Avet-LoiseauHFonsecaRSiegelDEfficacy and safety of carfilzomib, lenalidomide, and dexamethasone vs lenalidomide and dexamethasone in patients with relapsed multiple myeloma based on cytogenetic risk status: subgroup analysis from the phase 3 Study Aspire (NCT01080391) [abstract]Blood2015126731
- BergsagelPLMateosMVGutierrezNCRajkumarSVSan MiguelJFImproving overall survival and overcoming adverse prognosis in the treatment of cytogenetically high-risk multiple myelomaBlood201312188489223165477
- SonneveldPAvet-LoiseauHLonialSTreatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working GroupBlood2016127242955296227002115
- KristinssonSYAndersonWFLandgrenOImproved long-term survival in multiple myeloma up to the age of 80 yearsLeukemia2014281346134824418994
- PalumboABringhenSMateosMVGeriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group reportBlood20151252068207425628469
- DimopoulosMADelimpasiSKatodritouESignificant improvement in the survival of patients with multiple myeloma presenting with severe renal impairment after the introduction of novel agentsAnn Oncol20142519520024356630
- GreippPRSanMJDurieBGInternational staging system for multiple myelomaJ Clin Oncol2005233412342015809451
- CavoMPantaniLPetrucciMTBortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myelomaBlood201212091922498745
- DurieBHoeringARajkumarSVBortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate Autologous Stem Cell Transplant (ASCT): results of the randomized phase III trial SWOG S0777Blood201512625
- MoreauPHulinCMacroMVTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trialBlood20161272569257427002117
- PalumboABringhenSCaravitaTOral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trialLancet200636782583116530576
- PalumboABringhenSLiberatiAMOral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trialBlood20081123107311418505783
- RichardsonPGWellerELonialSLenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myelomaBlood201011667968620385792
- StewartAKRajkumarSVDimopoulosMACarfilzomib, lenalidomide, and dexamethasone for relapsed multiple myelomaN Engl J Med2015372142152
- DimopoulosMAOriolANahiHDaratumumab, lenalidomide, and dexamethasone for multiple myelomaN Engl J Med20163751319133127705267
- PalumboAChanan-KhanAWeiselKDaratumumab, bortezomib, and dexamethasone for multiple myelomaN Engl J Med201637575476627557302
- GarderetLIacobelliSMoreauPSuperiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation: the MMVAR/IFM 2005-04 Randomized Phase III Trial from the Chronic Leukemia Working Party of the European Group for Blood and Marrow TransplantationJ Clin Oncol2012302475248222585692
- BenboubkerLDimopoulosMADispenzieriALenalidomide and dexamethasone in transplant-ineligible patients with myelomaN Engl J Med201437190691725184863
- PalumboAHajekRDelforgeMContinuous lenalidomide treatment for newly diagnosed multiple myelomaN Engl J Med20123661759176922571200
- PalumboAGayFCavalloFContinuous therapy versus fixed duration of therapy in patients with newly diagnosed multiple myelomaJ Clin Oncol2015333459346626282661
- NebenKLokhorstHMJauchAAdministration of bortezomib before and after autologous stem cell transplantation improves outcome in multiple myeloma patients with deletion 17pBlood201211994094822160383
- RichardsonPGDelforgeMBeksacMManagement of treatment-emergent peripheral neuropathy in multiple myelomaLeukemia20122659560822193964
- AmgenKYPROLIS® (carfilzomib) for injection, for intravenous use [prescribing information]Thousand Oaks, CAOnyx Pharmaceuticals, Inc2016 Available from: http://pi.amgen.com/united_states/kyprolis/kyprolis_pi.pdfAccessed December 13, 2016
- BazRLinHMHuiAMDevelopment of a conceptual model to illustrate the impact of multiple myeloma and its treatment on health-related quality of life. SupportCare Cancer20152327892797
- RomanusDRajuAYongCDuration of therapy in U.S. patients treated for relapsed/refractory multiple myeloma (RRMM) in the real-world [abstract]Haematologica2016538 abstract E1301
- RichardsonPGPalumboAMateosMVThe current unmet medical needs in the treatment and management of multiple myelomaClin Lymphoma Myeloma Leuk201515e244
- San-MiguelJFHungriaVTYoonSSPanobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trialLancet Oncol2014151195120625242045
- LonialSDimopoulosMPalumboAElotuzumab therapy for relapsed or refractory multiple myelomaN Engl J Med201537362163126035255
- KuppermanELeeECCaoYEvaluation of the proteasome inhibitor MLN9708 in preclinical models of human cancerCancer Res2010701970198020160034
- Takeda Pharmaceuticals LimitedNILARO® (ixazomib) capsules, for oral use [prescribing information]2015 Available from: https://www.ninlarohcp.com/prescribing-information.pdfAccessed December 13, 2016
- GuptaNDiderichsenPMHanleyMJPopulation pharmacokinetic analysis of ixazomib, an oral proteasome inhibitor, including data from the phase III TOURMALINE-MM1 study to inform labellingClin Pharmacokinet Epub2017313
- KumarSKBerdejaJGNiesvizkyRSafety and tolerability of ixazomib, an oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma: an open-label phase 1/2 studyLancet Oncol2014151503151225456369
- KumarSKBensingerWIZimmermanTMPhase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myelomaBlood20141241047105524904120
- RichardsonPGBazRWangMPhase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patientsBlood20141241038104624920586
- GuptaNHanleyMJHarveyRDA pharmacokinetics and safety phase 1/1b study of oral ixazomib in patients with multiple myeloma and severe renal impairment or end-stage renal disease requiring haemodialysisBr J Haematol2016174574875927196567
- GuptaNHanleyMJVenkatakrishnanKPharmacokinetics of ixazomib, an oral proteasome inhibitor, in solid tumour patients with moderate or severe hepatic impairmentBr J Clin Pharmacol201682372873827121262
- GuptaNHuhYHutmacherMMIntegrated nonclinical and clinical risk assessment of the investigational proteasome inhibitor ixazomib on the QTc interval in cancer patientsCancer Chemother Pharmacol20157650751626141494
- GuptaNZhaoYHuiAMEsseltineDLVenkatakrishnanKSwitching from body surface area-based to fixed dosing for the investigational proteasome inhibitor ixazomib: a population pharmacokinetic analysisBr J Clin Pharmacol20157978980025377318
- JohnsonJAPredictability of the effects of race or ethnicity on pharmacokinetics of drugsInt J Clin Pharmacol Ther200038536010706191
- RamamoorthyAPacanowskiMBullJZhangLRacial/ethnic differences in drug disposition and response: Review of recently approved drugsClin Pharmacol Ther20159726327325669658
- YasudaSUZhangLHuangSMThe role of ethnicity in variability in response to drugs: focus on clinical pharmacology studiesClin Pharmacol Ther20088441742318615002
- GuptaNGohYTMinCKPharmacokinetics and safety of ixazomib plus lenalidomide-dexamethasone in Asian patients with relapsed/refractory myeloma: a phase 1 studyJ Hematol Oncol2015810326337806
- PalumboAMorganGRajkumarSVTwo phase 3 studies of the oral proteasome inhibitor (PI) ixazomib for multiple myeloma (MM) in the maintenance setting: TOURMALINE-MM3, and -MM4 [abstract]J Clin Oncol201634 abstr TPS8068
- GuptaNHanleyMJVenkatakrishnanKThe effect of a high-fat meal on the pharmacokinetics of ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors or lymphomaJ Clin Pharmacol201656101288129526872892
- RichardsonPGHofmeisterCCRosenbaumCATwice-weekly oral MLN9708 (ixazomib citrate), an investigational proteasome inhibitor, in combination with lenalidomide (len) and dexamethasone (dex) in patients (pts) with newly diagnosed multiple myeloma (MM): final phase 1 results and phase 2 data [abstract]Blood2013122535
- DimopoulosMAGrosickiSJedrzejczakWWRandomized phase 2 study of the all-oral combination of investigational proteasome inhibitor ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) in patients with newly diagnosed multiple myeloma who are transplant-ineligible (NCT02046070) [abstract]Blood20151262625827831
- San MiguelJFHajekRSpickaIOral MLN9708, an investigational proteasome inhibitor, in combination with melphalan and prednisone in patients with previously untreated multiple myeloma: a phase 1 study [abstract]Haematologica201297122210325
- GuptaNHanleyMJVenkatakrishnanKA phase 1 drug-drug interaction study between ixazomib, an oral proteasome inhibitor, and rifampin in patients with advanced solid tumors [abstract]Mol Center Ther20151412 Suppl 2 Abstract nr B147
- KumarSRoyVReederCBPhase 2 trial of single agent MLN9708 in patients with relapsed multiple myeloma not refractory to bortezomib [abstract]Blood20131221944
- KumarSLaplantBReederCBRandomized phase 2 trial of two different doses of ixazomib in patients with relapsed multiple myeloma not refractory to bortezomib [abstract]Blood20151263050
- HouJJinJXuYIxazomib plus lenelidomide-dexamethasone (IRd) vs placebo-Rd in patients with relapsed/refractory multiple myeloma: China continuation of TOURMALINE-MM1 [abstract]Haematologica2016101540
- LaubachJGarderetLMahindraAManagement of relapsed multiple myeloma: recommendations of the International Myeloma Working GroupLeukemia2016301005101726710887
- Avet-LoiseauHBahlisNChngWJImpact of cytogenetic risk status on efficacy and safety of ixazomib-lenalidomide-dexamethasone (IRd) vs placebo-Rd in relapsed/refractory multiple myeloma patients in the global TOURMALINE-MM1 study [abstract]Haematologica201610180
- MateosMVMassziTGrzaskoNEfficacy and safety of oral ixazomib-lenalidomide-dexamethasone (IRd) vs placebo-Rd in relapsed/refractory multiple myeloma patients: impact of prior therapy in the phase 3 TOURMALINE-MM1 study [abstract]Haematologica2016101527
- KumarSKLeeJHLahuertaJJRisk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group studyLeukemia20122614915721799510
- BrioliAMelchorLCavoMMorganGJThe impact of intra-clonal heterogeneity on the treatment of multiple myelomaBr J Haematol201416544145424580032
- KumarSFlinnIRichardsonPGRandomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myelomaBlood20121194375438222422823
- San MiguelJFSchlagRKhuagevaNKBortezomib plus melphalan and prednisone for initial treatment of multiple myelomaN Engl J Med200835990691718753647
- KrishnanAYKapoorPPalmerJA phase I/II study of ixazomib, pomalidomide, dexamethasone in relapsed refractory multiple myeloma: initial results [abstract]J Clin Oncol2016348008
- ReuFJValentJMalekEA phase 1 study of ixazomib in combination with panobinostat and dexamethasone in patients with relapsed or refractory multiple myeloma [abstract]Blood20151264221
- VoorheesPMulkeyFHassounHAlliance A061202. a phase I/II study of pomalidomide, dexamethasone and ixazomib versus pomalidomide and dexamethasone for patients with multiple myeloma refractory to lenalidomide and proteasome inhibitor based therapy: phase I results [abstract]Blood2015126375
- MoreauPPylypenkoHGrosickiSSubcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma: sub-analysis of patients with renal impairment in the phase III MMY-3021 studyHaematologica2015100e207e21025596270
- HarveyRDIncidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomibClin Pharmacol20146879624855395
- AaronsonNKAhmedzaiSBergmanBThe European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncologyJ Natl Cancer Inst1993853653768433390
- CocksKCohenDWisloffFAn international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myelomaEur J Cancer2007431670167817574838
- LeleuXMassziTBahlisNPatient-reported quality of life with ixazomib-lenalidomide-dexamethasone (IRd) vs placebo-Rd in relapsed/refractory multiple myeloma patients in the global, placebo-controlled TOURMALINE-MM1 study [abstract]Haematologica2016101261
- Food and Drug AdministrationGuidance for industry patient-reported outcome measures: use in medical product development to support labeling claims2009 27-10-0015
- RazzoukBIHordJDHockenberryMDouble-blind, placebo-controlled study of quality of life, hematologic end points, and safety of weekly epoetin alfa in children with cancer receiving myelosuppressive chemotherapyJ Clin Oncol2006243583358916877725
- GuptaNLabotkaRLiuGHuiAMVenkatakrishnanKExposure-safety-efficacy analysis of single-agent ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma: dose selection for a phase 3 maintenance studyInvest New Drugs20163433834627039387