BACKGROUND: Elotuzumab, an immunostimulatory monoclonal antibody targeting 
signaling lymphocytic activation molecule F7 (SLAMF7), showed activity in 
combination with lenalidomide and dexamethasone in a phase 1b-2 study in 
patients with relapsed or refractory multiple myeloma.
METHODS: In this phase 3 study, we randomly assigned patients to receive either 
elotuzumab plus lenalidomide and dexamethasone (elotuzumab group) or 
lenalidomide and dexamethasone alone (control group). Coprimary end points were 
progression-free survival and the overall response rate. Final results for the 
coprimary end points are reported on the basis of a planned interim analysis of 
progression-free survival.
RESULTS: Overall, 321 patients were assigned to the elotuzumab group and 325 to 
the control group. After a median follow-up of 24.5 months, the rate of 
progression-free survival at 1 year in the elotuzumab group was 68%, as compared 
with 57% in the control group; at 2 years, the rates were 41% and 27%, 
respectively. Median progression-free survival in the elotuzumab group was 19.4 
months, versus 14.9 months in the control group (hazard ratio for progression or 
death in the elotuzumab group, 0.70; 95% confidence interval, 0.57 to 0.85; 
P<0.001). The overall response rate in the elotuzumab group was 79%, versus 66% 
in the control group (P<0.001). Common grade 3 or 4 adverse events in the two 
groups were lymphocytopenia, neutropenia, fatigue, and pneumonia. Infusion 
reactions occurred in 33 patients (10%) in the elotuzumab group and were grade 1 
or 2 in 29 patients.
CONCLUSIONS: Patients with relapsed or refractory multiple myeloma who received 
a combination of elotuzumab, lenalidomide, and dexamethasone had a significant 
relative reduction of 30% in the risk of disease progression or death. (Funded 
by Bristol-Myers Squibb and AbbVie Biotherapeutics; ELOQUENT-2 
ClinicalTrials.gov number, NCT01239797.).