• Meletios A Dimopoulos, Dominik Dytfeld, Sebastian Grosicki, Philippe Moreau, Naoki Takezako, Mitsuo Hori, Xavier Leleu, Richard LeBlanc, Kenshi Suzuki, Marc S Raab, Paul G Richardson, Mihaela Popa McKiver, Ying-Ming Jou, Suresh G Shelat, Michael Robbins, Brian Rafferty, and Jesús San-Miguel.
• From the National and Kapodistrian University of Athens, Athens (M.A.D.); Karol Marcinkowski University of Medical Sciences, Poznań (D.D.), and Silesian Medical University, Katowice (S.G.) - both in Poland; University Hospital, Nantes (P.M.), and Centre Hospitalier Universitaire de Poitiers-La Milétrie, Poitiers (X.L.) - both in France; National Hospital Organization Disaster Medical Center (N.T.) and the Japanese Red Cross Medical Center (K.S.), Tokyo, and Ibaraki Prefectural Central Hospital, Kasama (M.H.) - all in Japan; Hôpital Maisonneuve-Rosemont, University of Montreal, Montreal (R.L.); Heidelberg University Hospital, Heidelberg, Germany (M.S.R.); Dana-Farber Cancer Institute, Boston (P.G.R.); Bristol-Myers Squibb, Princeton, NJ (M.P.M., Y.-M.J., S.G.S., M.R., B.R.); and Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra (IDISNA), Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Pamplona, Spain (J.S.-M.).
• N. Engl. J. Med. 2018 Nov 8; 379 (19): 1811-1822.

BackgroundThe immunostimulatory monoclonal antibody elotuzumab plus lenalidomide and dexamethasone has been shown to be effective in patients with relapsed or refractory multiple myeloma. The immunomodulatory agent pomalidomide plus dexamethasone has been shown to be effective in patients with multiple myeloma that is refractory to lenalidomide and a proteasome inhibitor.MethodsPatients with multiple myeloma that was refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor were randomly assigned to receive elotuzumab plus pomalidomide and dexamethasone (elotuzumab group) or pomalidomide and dexamethasone alone (control group). The primary end point was investigator-assessed progression-free survival.ResultsA total of 117 patients were randomly assigned to the elotuzumab group (60 patients) or the control group (57 patients). After a minimum follow-up period of 9.1 months, the median progression-free survival was 10.3 months in the elotuzumab group and 4.7 months in the control group. The hazard ratio for disease progression or death in the elotuzumab group as compared with the control group was 0.54 (95% confidence interval [CI], 0.34 to 0.86; P=0.008). The overall response rate was 53% in the elotuzumab group as compared with 26% in the control group (odds ratio, 3.25; 95% CI, 1.49 to 7.11). The most common grade 3 or 4 adverse events were neutropenia (13% in the elotuzumab group vs. 27% in the control group), anemia (10% vs. 20%), and hyperglycemia (8% vs. 7%). A total of 65% of the patients in each group had infections. Infusion reactions occurred in 3 patients (5%) in the elotuzumab group.ConclusionsAmong patients with multiple myeloma in whom treatment with lenalidomide and a proteasome inhibitor had failed, the risk of progression or death was significantly lower among those who received elotuzumab plus pomalidomide and dexamethasone than among those who received pomalidomide plus dexamethasone alone. (Funded by Bristol-Myers Squibb and AbbVie Biotherapeutics; ELOQUENT-3 ClinicalTrials.gov number, NCT02654132 .).

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