TY - JOUR
T1 - Elotuzumab therapy for relapsed or refractory multiple myeloma
AU - Lonial, Sagar
AU - Dimopoulos, Meletios Athanasios
AU - Palumbo, Antonio
AU - White, Darrell J
AU - Grosicki, Sebastian
AU - Spicka, Ivan
AU - Walter-Croneck, Adam
AU - Moreau, Philippe
AU - Mateos, Maria-Victoria
AU - Magen, Hila
AU - Belch, Andrew R
AU - Reece, Donna E
AU - Beksac, Meral
AU - Spencer, Andrew
AU - Oakervee, Heather
AU - Orlowski, Robert Z
AU - Taniwaki, Masafumi
AU - Rollig, Christoph
AU - Einsele, Hermann
AU - Wu, Ka Lung
AU - Singhal, Anil
AU - San Miguel, Jesus Fernando
AU - Matsumoto, Morio
AU - Katz, Jessica
AU - Bleickardt, Eric
AU - Poulart, Valerie
AU - Anderson, Kenneth Carl
AU - Richardson, Paul G
PY - 2015
Y1 - 2015
N2 - 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
AB - 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
UR - http://www.nejm.org/doi/full/10.1056/NEJMoa1505654
U2 - 10.1056/NEJMoa1505654
DO - 10.1056/NEJMoa1505654
M3 - Article
VL - 373
SP - 621
EP - 631
JO - The New England Journal of Medicine
JF - The New England Journal of Medicine
SN - 0028-4793
IS - 7
ER -