TY - JOUR
TI - Elotuzumab therapy for relapsed or refractory multiple myeloma
AU - Lonial, S.
AU - Dimopoulos, M.
AU - Palumbo, A.
AU - White, D.
AU - Grosicki, S.
AU - Spicka, I.
AU - Walter-Croneck, A.
AU - Moreau, P.
AU - Mateos, M.-V.
AU - Magen, H.
AU - Belch, A.
AU - Reece, D.
AU - Beksac, M.
AU - Spencer, A.
AU - Oakervee, H.
AU - Orlowski, R.Z.
AU - Taniwaki, M.
AU - Röllig, C.
AU - Einsele, H.
AU - Wu, K.L.
AU - Singhal, A.
AU - San-Miguel, J.
AU - Matsumoto, M.
AU - Katz, J.
AU - Bleickardt, E.
AU - Poulart, V.
AU - Anderson, K.C.
AU - Richardson, P.
AU - ELOQUENT-2 Investigators
JO - The New England journal of medicine
PY - 2015
VL - 373
TODO - 7
SP - 621-631
PB - Massachussetts Medical Society
SN - null
TODO - 10.1056/NEJMoa1505654
TODO - beta 2 microglobulin;  creatinine;  dexamethasone;  diphenhydramine;  elotuzumab;  lenalidomide;  paracetamol;  ranitidine;  antineoplastic agent;  dexamethasone;  elotuzumab;  immunoglobulin receptor;  lenalidomide;  monoclonal antibody;  SLAMF7 protein, human;  thalidomide, adult;  aged;  Article;  cancer growth;  cancer mortality;  cancer pain;  cancer survival;  chill;  controlled study;  creatinine clearance;  digestive system cancer;  drug efficacy;  drug response;  drug safety;  drug withdrawal;  fatigue;  fever;  heart disease;  herpes zoster;  human;  hypertension;  intention to treat analysis;  kidney disease;  lung embolism;  lymphocyte count;  lymphocytopenia;  major clinical study;  monotherapy;  multicenter study;  multiple cycle treatment;  multiple myeloma;  myelodysplastic syndrome;  neutropenia;  overall survival;  pain interference;  pain severity;  phase 3 clinical trial;  pneumonia;  priority journal;  progression free survival;  quality of life;  randomized controlled trial;  risk reduction;  survival time;  treatment duration;  analogs and derivatives;  antagonists and inhibitors;  clinical trial;  disease free survival;  middle aged;  mortality;  multiple myeloma;  recurrent disease;  very elderly, Adult;  Adult;  Aged;  Aged;  Aged, 80 and over;  Aged, 80 and over;  Antibodies, Monoclonal, Humanized;  Antibodies, Monoclonal, Humanized;  Antineoplastic Combined Chemotherapy Protocols;  Antineoplastic Combined Chemotherapy Protocols;  Dexamethasone;  Dexamethasone;  Disease-Free Survival;  Disease-Free Survival;  Humans;  Humans;  Middle Aged;  Middle Aged;  Multiple Myeloma;  Multiple Myeloma;  Receptors, Immunologic;  Receptors, Immunologic;  Recurrence;  Recurrence;  Thalidomide;  Thalidomide
TODO - 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. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
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