Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma.

Journal Article (Journal Article;Multicenter Study)

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 as #NCT01084252.

Full Text

Duke Authors

Cited Authors

  • Dimopoulos, M; Bringhen, S; Anttila, P; Capra, M; Cavo, M; Cole, C; Gasparetto, C; Hungria, V; Jenner, M; Vorobyev, V; Ruiz, EY; Yin, JY; Saleem, R; Hellet, M; Macé, S; Paiva, B; Vij, R

Published Date

  • March 4, 2021

Published In

Volume / Issue

  • 137 / 9

Start / End Page

  • 1154 - 1165

PubMed ID

  • 33080623

Pubmed Central ID

  • PMC7933767

Electronic International Standard Serial Number (EISSN)

  • 1528-0020

Digital Object Identifier (DOI)

  • 10.1182/blood.2020008209


  • eng

Conference Location

  • United States