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Of 45 patients enrolled, 36 patients received IRd after achieving at least a minor response to 3 cycles of bortezomib or carfilzomib plus LEN + DEX (VRd, n=6; KRd, n=30). At median follow-up of 20.8 months, the 12-month event-free survival rate (primary endpoint) was 49% (90% CI: 35.9\u221262.0), counting 11 events of progressive disease\/death, 8 dropouts and 4 missing response data. The 12-month progression-free survival (PFS) rate by Kaplan-Meier analysis (dropouts as censoring) was 74% (95% CI: 56\u221286). Median PFS and time to next treatment (95% CI) were 29.0 (21.3\u2212NE) and 32.3 (14.9\u221235.4) months, respectively; median OS was not evaluable. The overall response rate was 73%, and 42% of patients had a very good partial response or better. Frequent (\u226510% incidence) grade \u22653 treatment emergent adverse events were decreased neutrophil and platelet counts (n=7 [16%] each). Two deaths occurred (one during KRd treatment and one during IRd treatment), both due to pneumonia. IRd following injectable PI-based therapy was tolerable and efficacious in RRMM patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NCT03416374; Date of registration: January 31, 2018<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00277-023-05212-7","type":"journal-article","created":{"date-parts":[[2023,6,21]],"date-time":"2023-06-21T05:03:50Z","timestamp":1687323830000},"page":"2493-2504","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and Safety of Ixazomib Plus Lenalidomide and Dexamethasone Following Injectable PI-Based Therapy in Relapsed\/Refractory Multiple Myeloma"],"prefix":"10.1007","volume":"102","author":[{"given":"Yu","family":"Abe","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Sasaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoki","family":"Takezako","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigeki","family":"Ito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhito","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Handa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takaaki","family":"Chou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Yoshida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ikuo","family":"Mori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomohiro","family":"Shinozaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7132-5337","authenticated-orcid":false,"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,6,21]]},"reference":[{"issue":"10068","key":"5212_CR1","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1016\/S0140-6736(16)31594-X","volume":"389","author":"BGM Durie","year":"2017","unstructured":"Durie BGM, Hoering A, Abidi MH, Rajkumar SV, Epstein J, Kahanic SP, Thakuri M, Reu F, Reynolds CM, Sexton R, Orlowski RZ, Barlogie B, Dispenzieri A (2017) Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. 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Available from: https:\/\/www.takeda.com\/siteassets\/en-ca\/home\/what-we-do\/our-medicines\/product-monographs\/ninlaro\/ninlaro-pm-en.pdf Date Accessed: 25 Jan 2022"}],"updated-by":[{"DOI":"10.1007\/s00277-023-05355-7","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2023,7,11]],"date-time":"2023-07-11T00:00:00Z","timestamp":1689033600000}}],"container-title":["Annals of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00277-023-05212-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00277-023-05212-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00277-023-05212-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T08:09:38Z","timestamp":1692691778000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00277-023-05212-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,21]]},"references-count":28,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2023,9]]}},"alternative-id":["5212"],"URL":"https:\/\/doi.org\/10.1007\/s00277-023-05212-7","relation":{},"ISSN":["0939-5555","1432-0584"],"issn-type":[{"value":"0939-5555","type":"print"},{"value":"1432-0584","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,21]]},"assertion":[{"value":"13 December 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 April 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 June 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 July 2023","order":4,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":5,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s00277-023-05355-7","URL":"https:\/\/doi.org\/10.1007\/s00277-023-05355-7","order":7,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Statements and Declarations"}},{"value":"The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants\u2019 data supporting the results reported in this article, will be made available within three months from initial request, to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymization.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data-sharing statement"}},{"value":"Study design: Yu ABE, Makoto SASAKI, Naoki TAKEZAKO, Takaaki CHOU, Takahiro YOSHIDA, Ikuo MORI, Tomohiro SHINOZAKI, Kenshi SUZUKI; Data acquisition: Yu ABE, Makoto SASAKI, Naoki TAKEZAKO, Shigeki ITO, Kazuhito SUZUKI, Hiroshi HANDA, Takaaki CHOU, Kenshi SUZUKI; Analyses (including statistical): Takahiro YOSHIDA, Ikuo MORI, Tomohiro SHINOZAKI; Interpretation of data: all; Manuscript writing, feedback, and revisions: all.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship contributions"}},{"value":"The trial was designed by the steering committee members and the secondary sponsor (Takeda). The protocol was approved by the Certified Review Board and registered with the Ministry of Health, Labour and Welfare (Japan Registry of Clinical Trials). The trial was performed in accordance with the ethical standards specified in the 1964 Declaration of Helsinki and its later amendments. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. All patients provided written informed consent to participate in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"YA: No conflict\/s of interest to disclose.MS: Payment or honoraria was received from Janssen Pharmaceutical K.K., Takeda Pharmaceutical Co., and Sanofi for lectures, presentations, speaker\u2019s bureaus, manuscript writing or educational events.NT: No conflict\/s of interest to disclose.SI: Payment or honoraria was received from Takeda Pharmaceutical Co., Janssen, Sanofi, BMS, and Ono Pharmaceutical.KS: Honoraria for lectures was received from Takeda Pharmaceutical Co., Janssen Pharmaceutical K.K., and SanofiHH: Support for the presentation of the manuscript (e.g. funding, provision of study materials, medical writing, article processing charges etc.) was received from Takeda Pharmaceutical Co. Funding for grants was received from Takeda Pharmaceutical Co., BMS, Kyowa-Kirin, Chugai, and Nihon-Shinyaku. Consulting fees were received from Takeda Pharmaceutical Co., Janssen, BMS, Sanofi, and AbbVie. Payment or honoraria was received from Takeda Pharmaceutical Co., Janssen, BMS, Ezai, Sanofi, Ono Pharmaceutical, AbbVie, and Novartis.TC: No conflict\/s of interest to disclose.TY: Employee of Takeda Pharmaceutical Co.IM: Employee of Takeda Pharmaceutical Co.TS: Consulting fees (statistical analyses review), and support for attending a steering committee meeting, were received from Takeda Pharmaceutical Co.KS: Consulting fees were received from Amgen, Takeda Pharmaceutical Co., and BMS. Payment or honoraria was received from Takeda Pharmaceutical Co., Ono Pharmaceutical, Amgen, Novartis, Sanofi, BMS, AbbVie and Janssen.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}