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In this phase III trial, 286 patients with MM ineligible for ASCT received Rd with or without clarithromycin until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). With a median follow-up of 19 months (range, 0\u201354), no significant differences in the median PFS were observed between the two arms (C-Rd 23 months, Rd 29 months; HR 0.783, <jats:italic>p<\/jats:italic>\u2009=\u20090.14), despite a higher rate of complete response (CR) or better in the C-Rd group (22.6% vs 14.4%, <jats:italic>p<\/jats:italic>\u2009=\u20090.048). The most common G3\u20134 adverse events were neutropenia [12% vs 19%] and infections [30% vs 25%], similar between the two arms; however, the percentage of toxic deaths was higher in the C-Rd group (36\/50 [72%] vs 22\/40 [55%], <jats:italic>p<\/jats:italic>\u2009=\u20090.09). The addition of clarithromycin to Rd in untreated transplant ineligible MM patients does not improve PFS despite increasing the \u2265CR rate due to the higher number of toxic deaths in the C-Rd arm. Side effects related to overexposure to steroids due to its delayed clearance induced by clarithromycin in this elderly population could explain these results. The trial was registered in clinicaltrials.gov with the name GEM-CLARIDEX: Ld vs BiRd and with the following identifier NCT02575144. The full trial protocol can be accessed from ClinicalTrials.gov. This study received financial support from BMS\/Celgene.<\/jats:p>","DOI":"10.1038\/s41408-021-00490-8","type":"journal-article","created":{"date-parts":[[2021,5,21]],"date-time":"2021-05-21T14:03:24Z","timestamp":1621605804000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Lenalidomide and dexamethasone with or without clarithromycin in patients with multiple myeloma ineligible for autologous transplant: a randomized trial"],"prefix":"10.1038","volume":"11","author":[{"given":"Noemi","family":"Puig","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6576-7881","authenticated-orcid":false,"given":"Miguel T.","family":"Hern\u00e1ndez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Rosi\u00f1ol","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther","family":"Gonz\u00e1lez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Felipe","family":"de Arriba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6804-2221","authenticated-orcid":false,"given":"Albert","family":"Oriol","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ver\u00f3nica","family":"Gonz\u00e1lez-Calle","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernando","family":"Escalante","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"de la Rubia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mercedes","family":"Gironella","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafael","family":"R\u00edos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ricarda","family":"Garc\u00eda-S\u00e1nchez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jos\u00e9 M.","family":"Argui\u00f1ano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adri\u00e1n","family":"Alegre","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4250-4824","authenticated-orcid":false,"given":"Jes\u00fas","family":"Mart\u00edn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norma. 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M.T.H.: consulting or advisory role: Celgene, Janssen, Amgen, Takeda, GSK; speakers\u2019 bureau: Janssen, Celgene, Amgen. L.R.: honoraria from Janssen, Celgene, Amgen and Takeda. E.G.: no COIs to disclose. F.d.A.: honoraria from Janssen, Celgene, Amgen, GlaxoSmithKline and Takeda. A.O.: consultancy and speakers bureau for Celgene and Amgen, consultancy for Janssen, Sanofi, GSK. V.G.-C.: honoraria from Janssen and Celgene; research funding from Janssen (BECA SEHH-JANSSEN ESTANCIAS DE FORMACI\u00d3N EN EL EXTRANJERO 2016\u20132017); consulting or advisory role for Prothena and Janssen. F.E.: no COIs to disclose. J.d.l.R. has served as a consultant and provided expert testimony within the past 2 years for Amgen, Celgene, Takeda, Janssen, and Sanofi. M.G.: honoraria for Janssen, Celgene, Takeda and Amgen. R.R.: consulting or advisory role for Janssen and Celgene; R.G.S.: Consulting or advisory role: BMS\/Celgene, Janssen, Amgen, Takeda and GSK and speakers bureau from BMS\/Celgene, Janssen, Amgen and GSK. J.M.A.: no COIs to disclose. A.A.: Consultancy and membership on an entity\u00b4s Board of Directors or advisory committees for Celgene-BMS, Amgen, Janssen, Sanofi, GSK and Takeda. J.M.: travel, accommodations and expenses from Amgen and Sandoz. N.C.G.: honoraria from Janssen-Cilag. M.J.C.: no COIs to disclose. M.L.M.: no COIs to disclose. M.d.C.C.: no COIs to disclose. M.C.: no COIs to disclose. M.A.: consultancy and honoraria for Janssen, Bristol-Myers Squibb, Celgene, Amgen and Takeda. E.P.P.: speakers bureau for Celgene\/BMS, Amgen, Janssen, GSK. S.G.: consulting or advisory role for Janssen, Amgen, Takeda and Celgene. M.S.G.: no COIs to disclose. G.M.S.: no COIs to disclose. E.M.O.: Research funding: Array Pharmaceuticals, Mundipharma, Sanofi; consultancy, honoraria and research funding: Celgene, Amgen; consultancy and honoraria: Novartis, Takeda, Janssen; honoraria: B.M.S.; consultancy: AbbVie, Pharmamar, Seattle Genetics. M.C.: no COIs to disclose, C.E.: no COIs to disclose. A.M.V.: no COIs to disclose. A.I.T.: no COIs to disclose. M.C.R.: no COIs to disclose. B.P.: consultancy, honoraria, research funding and speaker\u2019s bureau for Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Roche and Sanofi; unrestricted grants from Celgene, EngMab and Takeda; consultancy for Celgene, Janssen and Sanofi; M.T.C.: Honoraria from Janssen, Celgene, Abbvie. J.F.S.-M.: consultancy or advisory role for Abbvie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Karyopharm, MSD, Novartis, Roche, Sanofi, SecuraBio and Takeda. J.J.L.: consulting or advisory role for Celgene, Takeda, Amgen, Janssen and Sanofi; travel accommodations and expenses for Celgene. J.B.: honoraria for Janssen, Celgene, Takeda, Amgen and Oncopeptides. R.N.: no COIs to disclose. M.V.M.: honoraria and membership on an entity\u00b4s Board of Directors or advisory committees for Janssen, Celgene, Takeda and Amgen, Adaptive, GSK, Sanofi and Oncopeptides; honoraria from membership in Board of Directors or advisory committees for Abbvie, Roche, Pfizer, Regeneron and Seattle Genetics.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}],"article-number":"101"}}