Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): A randomized, open-label, phase 3 trial
The Lancet Dec 19, 2019
Mateos MV, Cavo M, Blade J, et al. - This ALCYONE was a multicentre, randomized, open-label, active-controlled, phase 3 trial that recruited individuals between Feb 9, 2015, and July 14, 2016, at 162 sites in 25 countries across North America, South America, Europe, and the Asia-Pacific region to report updated efficacy and safety results from a prespecified, interim, overall survival analysis of ALCYONE with more than 36 months of follow-up. A total of 706 people were randomized in a 1:1 ratio and by permuted block randomization to receive daratumumab in combination with bortezomib, melphalan, and prednisone (D-VMP) or bortezomib, melphalan, and prednisone (VMP). In people with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation, overall survival was prolonged by D-VMP. With more than 3 years of follow-up, the D-VMP group persisted to show important enhancement in progression-free survival, with no new safety interests.
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