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

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http://hdl.handle.net/10138/334769

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Dimopoulos , M , Bringhen , S , Anttila , P , Capra , M , Cavo , M , Cole , C , Gasparetto , C , Hungria , V , Jenner , M , Vorobyev , V , Ruiz , E Y , Yin , J Y , Saleem , R , Hellet , M , Mace , S , Paiva , B & Vij , R 2021 , ' Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma ' , Blood , vol. 137 , no. 9 , pp. 1154-1165 . https://doi.org/10.1182/blood.2020008209

Title: Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma
Author: Dimopoulos, Meletios; Bringhen, Sara; Anttila, Pekka; Capra, Marcelo; Cavo, Michele; Cole, Craig; Gasparetto, Cristina; Hungria, Vania; Jenner, Matthew; Vorobyev, Vladimir; Ruiz, Eduardo Yanez; Yin, Jian Y.; Saleem, Rao; Hellet, Maeva; Mace, Sandrine; Paiva, Bruno; Vij, Ravi
Contributor organization: HUS Comprehensive Cancer Center
Hematologian yksikkö
Helsinki University Hospital Area
Date: 2021-03-04
Language: eng
Number of pages: 12
Belongs to series: Blood
ISSN: 0006-4971
DOI: https://doi.org/10.1182/blood.2020008209
URI: http://hdl.handle.net/10138/334769
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.
Subject: 3122 Cancers
Peer reviewed: Yes
Usage restriction: openAccess
Self-archived version: publishedVersion


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