Ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory myeloma: MUKeight phase II randomised controlled trial results.
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Date
2022-04-01ICR Author
Author
Auner, HW
Brown, SR
Walker, K
Kendall, J
Dawkins, B
Meads, D
Morgan, GJ
Kaiser, MF
Cook, M
Roberts, S
Parrish, C
Cook, G
Type
Journal Article
Metadata
Show full item recordAbstract
The all-oral combination of ixazomib, cyclophosphamide, and dexamethasone (ICD) is well tolerated and effective in newly diagnosed and relapsed multiple myeloma (MM). We carried out MUKeight, a randomised, controlled, open, parallel group, multi-centre phase II trial in patients with relapsed MM after prior treatment with thalidomide, lenalidomide, and a proteasome inhibitor (ISRCTN58227268), with the primary objective to test whether ICD has improved clinical activity compared to cyclophosphamide and dexamethasone (CD) in terms of progression-free survival (PFS). Between January 2016 and December 2018, 112 participants were randomised between ICD (n = 58) and CD (n = 54) in 33 UK centres. Patients had a median age of 70 years and had received a median of four prior lines of therapy. 74% were classed as frail. Median PFS in the ICD arm was 5.6 months, compared to 6.7 months with CD (hazard ratio (HR) = 1.21, 80% CI 0.9-1.6, p = 0.3634). Response rates and overall survival were not significantly different between ICD and CD. Dose modifications or omissions, and serious adverse events (SAEs), occurred more often in the ICD arm. In summary, the addition of ixazomib to cyclophosphamide and dexamethasone did not improve outcomes in the comparatively frail patients enroled in the MUKeight trial.
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Subject
Humans
Multiple Myeloma
Boron Compounds
Cyclophosphamide
Dexamethasone
Glycine
Antineoplastic Combined Chemotherapy Protocols
Aged
Research team
Myeloma Molecular Therapy
Language
eng
Date accepted
2022-01-24
Citation
Blood cancer journal, 2022, 12 (4), pp. 52 - ?
Publisher
SPRINGERNATURE