@article{2999932,
    title = "Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma",
    author = "Dimopoulos, M. and Bringhen, S. and Anttila, P. and Capra, M. and Cavo, M. and Cole, C. and Gasparetto, C. and Hungria, V. and Jenner, M. and Vorobyev, V. and Ruiz, E.Y. and Yin, J.Y. and Saleem, R. and Hellet, M. and Macé, S. and Paiva, B. and Vij, R.",
    journal = "Blood advances",
    year = "2021",
    volume = "137",
    number = "9",
    pages = "1154-1165",
    publisher = "Elsevier B.V.",
    doi = "10.1182/blood.2020008209",
    keywords = "ADP ribosyl cyclase/cyclic ADP ribose hydrolase 1;  alkylating agent;  bortezomib;  carfilzomib;  CD16 antigen;  CD3 antigen;  CD56 antigen;  cyt 38f 2;  daratumumab;  dexamethasone;  diphenhydramine;  Fc receptor;  immunoglobulin A;  immunoglobulin G;  isatuximab;  lenalidomide;  M protein;  methylprednisolone;  paracetamol;  pomalidomide;  ranitidine;  antineoplastic agent;  immunological antineoplastic agent;  isatuximab;  monoclonal antibody;  thalidomide, adult;  adverse drug reaction;  aged;  arthralgia;  Article;  asthenia;  backache;  bone pain;  bronchitis;  cancer patient;  cancer recurrence;  cancer staging;  cancer survival;  chill;  clinical evaluation;  constipation;  controlled study;  coughing;  decreased appetite;  diarrhea;  disease exacerbation;  drug dose increase;  drug efficacy;  drug safety;  drug withdrawal;  dyspepsia;  dyspnea;  fatigue;  fever;  gastrointestinal disease;  headache;  human;  immunomodulation;  incidence;  infestation;  infusion related reaction;  insomnia;  limb pain;  major clinical study;  mediastinum disease;  mental disease;  metabolic disorder;  monotherapy;  multicenter study;  multiple cycle treatment;  multiple myeloma;  musculoskeletal chest pain;  musculoskeletal pain;  myalgia;  nausea;  neurologic disease;  nose obstruction;  nutritional disorder;  outcome assessment;  overall response rate;  overall survival;  pain;  peripheral edema;  phase 1 clinical trial;  phase 2 clinical trial;  pneumonia;  priority journal;  progression free survival;  randomized controlled trial;  respiratory tract infection;  rhinopharyngitis;  thorax disease;  treatment duration;  treatment response;  upper respiratory tract infection;  urinary tract infection;  vomiting;  clinical trial;  female;  male;  middle aged;  multiple myeloma;  treatment outcome;  tumor recurrence;  very elderly, Adult;  Aged;  Aged, 80 and over;  Antibodies, Monoclonal, Humanized;  Antineoplastic Agents, Immunological;  Antineoplastic Combined Chemotherapy Protocols;  Female;  Humans;  Male;  Middle Aged;  Multiple Myeloma;  Neoplasm Recurrence, Local;  Progression-Free Survival;  Thalidomide;  Treatment Outcome",
    abstract = "This phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM). Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ≥3 prior lines of therapy incorporating an IMiD and PI. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/d [20 mg/d in patients aged ≥75 years] once weekly; Isa-dex group). Treated patients (N = 164) had received a median of 4 (range, 2-10) prior treatment lines. Patients received a median of 5 (1-24) and 7 (1-22) treatment cycles; at data cutoff, 13 (11.9%) of 109 and 15 (27.3%) of 55 patients remained on treatment in the Isa and Isa-dex arms, respectively. Overall response rate (primary efficacy end point) was 23.9% in the Isa arm and 43.6% in the Isa-dex arm (odds ratio, 0.405; 95% confidence interval, 0.192-0.859; P = .008). Median progression-free survival and overall survival were 4.9 and 18.9 months for Isa, and 10.2 and 17.3 months for Isa-dex. Infusion reactions (mostly grade 1/2) and hematologic abnormalities were the most common adverse events. There was a similar incidence of grade 3 or higher infections in both groups (22.0% and 21.8%). In conclusion, addition of dexamethasone to isatuximab increased response rates and survival outcomes with no detrimental effect on safety. This trial was registered at www.clinicaltrials.gov as #NCT01084252. Key Points: • In myeloma patients with a median 4 prior therapy lines, adding dexamethasone to isatuximab increased response rates from 23.9% to 43.6%. • Dexamethasone improved isatuximab efficacy with no detrimental effect on safety, supporting the use of this combination regimen. © 2021 American Society of Hematology"
}