In patients with multiple myeloma who did not respond to treatment with lenalidomide and a proteasome inhibitor, the risk of progression or death was significantly lower among patients who received elotuzumab plus pomalidomide and dexamethasone compared with those who received pomalidomide plus dexamethasone alone, according to results from a study published in the New England Journal of Medicine.
The phase 2 ELOQUENT-3 multicenter, randomized, open-label study assessed patients with multiple myeloma that was refractory or relapsed and refractory to treatment with lenalidomide and a proteasome inhibitor. The primary endpoint was progression-free survival.
A total of 117 patients were randomly assigned to receive elotuzumab plus pomalidomide and dexamethasone (elotuzumab group, 60 patients; median age, 69 years [43-81]; 53% male) or pomalidomide and dexamethasone alone (control group, 57 patients; median age, 66 years [36-81]; 61% male).
Median progression-free survival was more than twice as long in the elotuzumab group (10.3 months) as in the control group (4.7 months). The hazard ratio for disease progression or death in the elotuzumab group compared with the control group was 0.54 (95% CI: 0.34-0.86, P =.008). The overall response rate was higher in the elotuzumab group compared with the control group (53% vs 26%, odds ratio 3.25, 95% CI: 1.49-7.11).
Neutropenia (13% vs 27%), anemia (10% vs 20%), and hyperglycemia (8% vs 7%) were the most common grade 3 and 4 adverse events in the elotuzumab and control group, respectively. In both groups, 65% of the patients had infections. Only 3 patients (5%) had infusion reactions in the elotuzumab group; all reactions were grade 1 or 2 and all resolved.
The investigators concluded that “extended follow-up is warranted to determine long-term efficacy and safety outcomes” of the elotuzumab-based combination therapy for relapsed or refractory multiple myeloma.
1. Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018;379:1811-1822. doi: 10.1056/NEJMoa1805762