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The PFS was modeled based on dynamic M\u2010protein data from two phase III studies, POLLUX and CASTOR, which included 569 and 498 patients with relapsed\/refractory MM, respectively. Both studies compared active controls (lenalidomide and dexamethasone, and bortezomib and dexamethasone, respectively) alone vs. in combination with daratumumab. Three M\u2010protein dynamic features from the longitudinal M\u2010protein data were evaluated up to different time cutoffs (1, 2, 3, and 6\u00a0months). The abilities of early M\u2010protein dynamic measurements to predict the PFS were evaluated using Cox proportional hazards survival models. Both univariate and multivariable analyses suggest that maximum reduction of M\u2010protein (i.e., depth of response) was the most predictive of PFS. Despite the statistical significance, the baseline covariates provided very limited predictive value regarding the treatment effect of daratumumab. However, M\u2010protein dynamic features obtained within the first 2\u00a0months reasonably predicted PFS and the associated treatment effect of daratumumab. Specifically, the areas under the time\u2010varying receiver operating characteristic curves for the model with the first 2\u00a0months of M\u2010protein dynamic data were ~\u00a00.8 and 0.85 for POLLUX and CASTOR, respectively. Early M\u2010protein data within the first 2\u00a0months can provide a prospective and reasonable prediction of future long\u2010term clinical benefit for patients with MM.<\/jats:p>","DOI":"10.1111\/cts.12836","type":"journal-article","created":{"date-parts":[[2020,6,25]],"date-time":"2020-06-25T10:19:52Z","timestamp":1593080392000},"page":"1345-1354","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Early M\u2010Protein Dynamics Predicts Progression\u2010Free Survival in Patients With Relapsed\/Refractory Multiple Myeloma"],"prefix":"10.1111","volume":"13","author":[{"given":"Xiaoyu","family":"Yan","sequence":"first","affiliation":[{"name":"Faculty of Medicine School of Pharmacy The Chinese University of Hong Kong Shatin, New Territories Hong Kong SAR Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xu Steven","family":"Xu","sequence":"additional","affiliation":[{"name":"Janssen Research and Development Raritan Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katja C.","family":"Weisel","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Hamburg \u2013 Eppendorf II. Medizinische Klinik und Poliklinik Hamburg Germany"},{"name":"University of Tuebingen Tuebingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria\u2010Victoria","family":"Mateos","sequence":"additional","affiliation":[{"name":"University Hospital of Salamanca\u2013Instituto de Investigaci\u00f3n Biom\u00e9dica de Salamanca (IBSAL) Salamanca Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pieter","family":"Sonneveld","sequence":"additional","affiliation":[{"name":"Department of Hematology Erasmus Medical Center Rotterdam Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meletios A.","family":"Dimopoulos","sequence":"additional","affiliation":[{"name":"National and Kapodistrian University of Athens School of Medicine Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saad Zafar","family":"Usmani","sequence":"additional","affiliation":[{"name":"Levine Cancer Institute Carolinas 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