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The addition of vorinostat to lenalidomide maintenance for patients with newly diagnosed multiple myeloma of all ages: results from ‘Myeloma XI’, a multicentre, open-label, randomised, phase III trial

Lookup NU author(s): Professor Graham Jackson

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2022 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.Lenalidomide is an effective maintenance agent for patients with myeloma, prolonging first remission and, in transplant eligible patients, improving overall survival (OS) compared to observation. The ‘Myeloma XI’ trial, for newly diagnosed patients, aimed to evaluate whether the addition of the histone deacetylase inhibitor vorinostat to the lenalidomide maintenance backbone could improve outcomes further. Patients included in this analysis were randomised to maintenance therapy with lenalidomide alone (10 mg/day on days 1–21 of each 28-day cycle), or in combination with vorinostat (300 mg/day on day 1–7 and 15–21 of each 28-day cycle) with treatment continuing until unacceptable toxicity or progressive disease. There was no significant difference in median progression-free survival between those receiving lenalidomide-vorinostat or lenalidomide alone, 34 and 40 months respectively (hazard ratio [HR] 1.18, 95% confidence interval [CI] 0.96–1.44, p = 0.109). There was also no significant difference in median OS, not estimable and 75 months respectively (HR 0.99, 95% CI 0.76–1.29, p = 0.929). Subgroup analysis demonstrated no statistically significant heterogeneity in outcomes. Combination lenalidomide-vorinostat appeared to be poorly tolerated with more dose modifications, fewer cycles of maintenance therapy delivered and higher rates of discontinuation due to toxicity than lenalidomide alone. The trial did not meet its primary end-point, there was no benefit from the addition of vorinostat to lenalidomide maintenance.

Publication metadata

Author(s): Jenner MW, Pawlyn C, Davies FE, Menzies T, Hockaday A, Olivier C, Jones JR, Karunanithi K, Lindsay J, Kishore B, Cook G, Drayson MT, Kaiser MF, Owen RG, Gregory W, Cairns DA, Morgan G, Jackson GH

Publication type: Article

Publication status: Published

Journal: British Journal of Haematology

Year: 2023

Volume: 201

Issue: 2

Pages: 267-279

Print publication date: 05/04/2023

Online publication date: 21/12/2022

Acceptance date: 28/11/2022

Date deposited: 09/01/2023

ISSN (print): 0007-1048

ISSN (electronic): 1365-2141

Publisher: John Wiley and Sons Inc

URL: https://doi.org/10.1111/bjh.18600

DOI: 10.1111/bjh.18600

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