Carfilzomib or bortezomib in combination with cyclophosphamide and dexamethasone followed by carfilzomib maintenance for patients with multiple myeloma after one prior therapy: results from a multi-centre, phase II, randomized, controlled trial (MUKfive)
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
The proteasome inhibitors (PIs), carfilzomib and bortezomib, are widely used to treat myeloma but head-to-head comparisons have produced conflicting results. We compared the activity of these PIs in combination with cyclophosphamide and dexamethasone (KCd vs VCd) in second line treatment using fixed duration therapy and evaluated the efficacy of carfilzomib maintenance. MUKfive was a phase II controlled, parallel group trial that randomised patients (2:1) to KCd (201) or VCd (99); responding patients on carfilzomib were randomised to maintenance carfilzomib (69) or no further treatment (72). Primary endpoints were (i) very good partial response (VGPR, non-inferiority, OR 0.8) at 24 weeks, and (ii) progression-free survival (PFS). More participants achieved ≥VGPR with carfilzomib compared to bortezomib (40.2% vs. 31.9%, OR=1.48, 90%CI:0.95,2.31; non-inferior), with a trend for particular benefit in adverse risk disease. KCd was associated with higher overall response (≥PR, 84.0% vs. 68.1%, OR=2.72, 90%CI:1.62,4.55, p=0.001). Neuropathy (grade ≥3 or ≥2 with pain) was more common with bortezomib (19.8% vs. 1.5%, p.
Date Issued
2021-10-01
Date Acceptance
2021-04-01
Citation
Haematologica: the hematology journal, 2021, 106 (10), pp.2694-2706
ISSN
0390-6078
Publisher
Ferrata Storti Foundation
Start Page
2694
End Page
2706
Journal / Book Title
Haematologica: the hematology journal
Volume
106
Issue
10
Copyright Statement
© 2021 The Author(s). This paper is published under a Creative Commons license CC BY-NC-ND.
Sponsor
Myeloma UK
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/33910333
Subjects
Immunology
1102 Cardiorespiratory Medicine and Haematology
Publication Status
Published
Coverage Spatial
Italy
Date Publish Online
2021-04-29