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Patients with relapsed\/refractory MM (RRMM) can be enrolled in early-phase clinical trials, but their performance across the last decade is unknown. We conducted a meta-analysis on the overall response rate (ORR) and toxicity. PubMed, Embase, and Cochrane Library were systematically searched for phase I and phase II trials investigating an experimental compound as a single agent or in combination with dexamethasone, published from January 1, 2010 to July 1, 2020. Eighty-eight articles were included, describing 61 phase I trials involving 1835 patients and 37 phase II trials involving 2644 patients. There was a high degree of heterogeneity. Using a random-effects model, the 95% CIs of the estimated ORR were 8\u201317% for phase I trials and 18\u201328% for phase II trials. There were significant subgroup differences in ORR between the years of publication in phase I trials and between drug classes in both phase I and phase II trials. The ORR in early-phase clinical trials in RRMM is substantial, especially in phase II trials, but due to high heterogeneity a general assessment of clinical benefit before participation is difficult to offer to patients.<\/jats:p>","DOI":"10.1038\/s41408-021-00441-3","type":"journal-article","created":{"date-parts":[[2021,3,1]],"date-time":"2021-03-01T15:02:28Z","timestamp":1614610948000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Therapeutic outcome of early-phase clinical trials in multiple myeloma: a meta-analysis"],"prefix":"10.1038","volume":"11","author":[{"given":"Niels","family":"van Nieuwenhuijzen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8283-273X","authenticated-orcid":false,"given":"Rowan","family":"Frunt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne M.","family":"May","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3139-8379","authenticated-orcid":false,"given":"Monique C.","family":"Minnema","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,3,1]]},"reference":[{"key":"441_CR1","doi-asserted-by":"publisher","first-page":"278","DOI":"10.1200\/JCO.2014.58.2635","volume":"33","author":"JS Weber","year":"2015","unstructured":"Weber, J. 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JAMA Oncol. 2, 1452\u20131459 (2016).","journal-title":"JAMA Oncol."}],"container-title":["Blood Cancer Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41408-021-00441-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41408-021-00441-3","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41408-021-00441-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,22]],"date-time":"2023-10-22T06:15:42Z","timestamp":1697955342000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41408-021-00441-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,1]]},"references-count":116,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2021,3]]}},"alternative-id":["441"],"URL":"https:\/\/doi.org\/10.1038\/s41408-021-00441-3","relation":{},"ISSN":["2044-5385"],"issn-type":[{"value":"2044-5385","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,1]]},"assertion":[{"value":"11 December 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 February 2021","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 February 2021","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 March 2021","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Prof. Dr. M.C.M. declares the following potential conflicts of interest: Research funding: Celgene (paid to the employer). Advisory Boards: Celgene, Jansen Cilag, Amgen, Takeda, Servier (paid to the employer). Training: Gilead (paid to the employer). The remaining authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}],"article-number":"44"}}