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However, application in the real-world setting, including feasibility of and adherence to these regimens, may be limited due to varying patient-, treatment-, and disease-related factors. Furthermore, approximately 40% of real-world MM patients do not meet the criteria for phase 3 studies on which approvals are based, resulting in a lack of representative phase 3 data for these patients. Therefore, treatment decisions must be tailored based on additional considerations beyond clinical trial efficacy and safety, such as treatment feasibility (including frequency of clinic\/hospital attendance), tolerability, effects on quality of life (QoL), and impact of comorbidities. There are multiple factors of importance to real-world MM patients, including disease symptoms, treatment burden and toxicities, ability to participate in daily activities, financial burden, access to treatment and treatment centers, and convenience of treatment. All of these factors are drivers of QoL and treatment satisfaction\/compliance. Importantly, given the heterogeneity of MM, individual patients may have different perspectives regarding the most relevant considerations and goals of their treatment. Patient perspectives\/goals may also change as they move through their treatment course. Thus, the \u2018efficacy\u2019 of treatment means different things to different patients, and treatment decision-making in the context of personalized medicine must be guided by an individual\u2019s composite definition of what constitutes the best treatment choice. This review summarizes the various factors of importance and practical issues that must be considered when determining real-world treatment choices. It assesses the current instruments, methodologies, and recent initiatives for analyzing the MM patient experience. Finally, it suggests options for enhancing data collection on patients and treatments to provide a more holistic definition of the effectiveness of a regimen in the real-world setting.<\/jats:p>","DOI":"10.1038\/s41408-021-00432-4","type":"journal-article","created":{"date-parts":[[2021,2,20]],"date-time":"2021-02-20T12:23:53Z","timestamp":1613823833000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":111,"title":["Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life"],"prefix":"10.1038","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5133-1422","authenticated-orcid":false,"given":"Evangelos","family":"Terpos","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Mikhael","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6955-6267","authenticated-orcid":false,"given":"Roman","family":"Hajek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajai","family":"Chari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonja","family":"Zweegman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans C.","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2390-1218","authenticated-orcid":false,"given":"Mar\u00eda-Victoria","family":"Mateos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2070-3702","authenticated-orcid":false,"given":"Alessandra","family":"Larocca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karthik","family":"Ramasamy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3677-4804","authenticated-orcid":false,"given":"Martin","family":"Kaiser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gordon","family":"Cook","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9422-6614","authenticated-orcid":false,"given":"Katja C.","family":"Weisel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caitlin L.","family":"Costello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Elliott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1763-6609","authenticated-orcid":false,"given":"Antonio","family":"Palumbo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saad Z.","family":"Usmani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,2,18]]},"reference":[{"key":"432_CR1","doi-asserted-by":"publisher","first-page":"5419","DOI":"10.1158\/1078-0432.CCR-16-0625","volume":"22","author":"KC Anderson","year":"2016","unstructured":"Anderson, K. C. Progress and paradigms in multiple myeloma. Clin. Cancer Res. 22, 5419\u20135427 (2016).","journal-title":"Clin. Cancer Res."},{"key":"432_CR2","doi-asserted-by":"publisher","first-page":"2015","DOI":"10.3390\/cancers11122015","volume":"11","author":"M D\u2019Agostino","year":"2019","unstructured":"D\u2019Agostino, M., Bertamini, L., Oliva, S., Boccadoro, M. & Gay, F. Pursuing a curative approach in multiple myeloma: a review of new therapeutic strategies. Cancers (Basel) 11, 2015 (2019).","journal-title":"Cancers (Basel)"},{"key":"432_CR3","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1182\/asheducation-2017.1.205","volume":"2017","author":"FE Davies","year":"2017","unstructured":"Davies, F. E. Is molecular remission the goal of multiple myeloma therapy? Hematology Am. Soc. Hematol. Educ. Program 2017, 205\u2013211 (2017).","journal-title":"Hematology Am. Soc. Hematol. Educ. 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J.M.: Consultancy for Amgen, Celgene, GSK, Janssen, Karyopharm, Sanofi, and Takeda. R.H.: Consultancy, honoraria, membership on an entity\u2019s board of directors or advisory committees and research funding for Janssen, Amgen, Celgene and Bristol-Myers Squibb; consultancy for AbbVie; consultancy and research funding for Novartis; consultancy, honoraria and membership on an entity\u2019s Board of Directors or advisory committees for PharmaMar; consultancy, consultant or advisory relationship, honoraria, membership on an entity\u2019s board of directors or advisory committees and research funding for Takeda. A.C.: Consultancy for Janssen, Celgene, Novartis, Amgen, Bristol-Myers Squibb, Takeda, Antengene, and Secura Bio; advisory boards with Janssen, Celgene, Novartis, Amgen, Karyopharm, Sanofi, Seattle Genetics, Oncopeptides, GlaxoSmithKline, and Secura Bio; research funding from Janssen, Celgene, Novartis, Amgen, Pharmacyclics, Seattle Genetics, and Takeda. S.Z.: Research funding from and advisory boards for Takeda, Celgene, and Janssen. H.C.L.: Membership on an entity\u2019s board of directors or advisory committees for Amgen, Sanofi, Celgene, Genentech, GlaxoSmithKline plc, Takeda, and Janssen; research funding from Takeda, Amgen, Janssen, Celgene, GlaxoSmithKline plc, and Daiichi Sankyo. M.V.M.: Personal fees from Takeda, Janssen, Amgen, Celgene, GSK, and Abbvie. A.L.: Advisory boards for Bristol-Myers Squibb, Celgene, Janssen, and Takeda; honoraria from Amgen, Bristol-Myers Squibb, Celgene, Janssen, and GSK. K.R.: Takeda: honoraria, research funding; Amgen: honoraria; Janssen: honoraria; Celgene: honoraria, research funding; Adaptive Biotech: Honoraria; Oncopeptides: Honoraria. M.K.: Consultancy for Amgen, Janssen, Takeda, Celgene\/BMS, GSK, Karyopharm, and Abbvie; institutional research funding from Janssen and Celgene\/BMS; travel support from Janssen and Takeda. G.C.: Consultancy, honoraria, research funding and speakers bureau for Janssen, Takeda and Celgene; consultancy, honoraria and speakers bureau for Sanofi and Karyopharm. K.C.W.: Advisory boards for Amgen, Bristol-Myers Squibb, Adaptive Biotech, Celgene, Janssen, Juno, Takeda, Sanofi; honoraria from Amgen, Bristol-Myers Squibb, Celgene, Janssen, and Takeda; research funding from Amgen, Celgene, Janssen, and Sanofi. C.L.C.: Honoraria and research funding for Takeda; research funding for Janssen; consultancy, honoraria and research funding for Celgene. J.E. and A.P.: Employment, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. S.Z.U.: Consultancy, patents & royalties, research funding and speakers bureau for Amgen, Celgene, Janssen and Takeda; patents & royalties and research funding for Array Biopharma and Pharmacyclics; consultancy and research funding for Bristol-Myers Squibb and Merck; patents & royalties, research funding and speakers bureau for Sanofi; consultancy for Skyline DX.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}],"article-number":"40"}}