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.
Loading...
Embargo End Date
ICR Authors
Authors
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, GJ
Jackson, GH
UK National Cancer Research Institute (NCRI) Haemato-oncology Clinical Studies Group,
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, GJ
Jackson, GH
UK National Cancer Research Institute (NCRI) Haemato-oncology Clinical Studies Group,
Document Type
Journal Article
Date
2022-12-21
Date Accepted
2022-11-28
Abstract
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.
Citation
British Journal of Haematology, 2022,
Source Title
British Journal of Haematology
Publisher
WILEY
ISSN
0007-1048
eISSN
1365-2141
1365-2141
1365-2141
Collections
Research Team
Myeloma Biol Therap
Myeloma Molecular Therapy
Myeloma Molecular Therapy