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Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial

Authors :
Meletios A. Dimopoulos
Fredrik Schjesvold
Vadim Doronin
Olga Vinogradova
Hang Quach
Xavier Leleu
Yolanda Gonzalez Montes
Karthik Ramasamy
Alessandra Pompa
Mark-David Levin
Cindy Lee
Ulf Henrik Mellqvist
Roland Fenk
Hélène Demarquette
Hamdi Sati
Alexander Vorog
Richard Labotka
Jichang Du
Mohamed Darif
Shaji Kumar
Source :
Blood Cancer Journal, Vol 12, Iss 1, Pp 1-10 (2022), Blood Cancer Journal
Publication Year :
2022
Publisher :
Nature Publishing Group, 2022.

Abstract

Multiple myeloma (MM) patients typically receive several lines of combination therapy and first-line treatment commonly includes lenalidomide. As patients age, they become less tolerant to treatment, requiring convenient/tolerable/lenalidomide-free options. Carfilzomib and/or bortezomib-exposed/intolerant, lenalidomide-refractory MM patients with ≥2 prior lines of therapy were randomized 3:2 to ixazomib-dexamethasone (ixa-dex) (n = 73) or pomalidomide-dexamethasone (pom-dex) (n = 49) until progression/toxicity. Median progression-free survival (mPFS) was 7.1 vs 4.8 months with ixa-dex vs pom-dex (HR 0.847, 95% CI 0.535–1.341, P = 0.477; median follow-up: 15.3 vs 17.3 months); there was no statistically significant difference between arms. In patients with 2 and ≥3 prior lines of therapy, respectively, mPFS was 11.0 vs 5.7 months (HR 1.083, 95% CI 0.547–2.144) and 5.7 vs 3.7 months (HR 0.686, 95% CI 0.368–1.279). Among ixa-dex vs pom-dex patients, 69% vs 81% had Grade ≥3 treatment-emergent adverse events (TEAEs), 51% vs 53% had serious TEAEs, 39% vs 36% had TEAEs leading to drug discontinuation, 44% vs 32% had TEAEs leading to dose reduction, and 13% vs 13% died on study. Quality of life was similar between arms and maintained during treatment. Ixa-dex represents an important lenalidomide-free, oral option for this heavily pretreated, lenalidomide-refractory, proteasome inhibitor-exposed population.Trial registration: ClinicalTrials.gov number, NCT03170882.

Details

Language :
English
ISSN :
20445385
Volume :
12
Issue :
1
Database :
OpenAIRE
Journal :
Blood Cancer Journal
Accession number :
edsair.doi.dedup.....65da36f32ee909f865844f8cd31a5ff8