Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma (FiTNEss (UK-MRA Myeloma XIV Trial)): a study protocol for a randomised phase III trial.
Date
2022-06-02Author
Coulson, AB
Royle, K-L
Pawlyn, C
Cairns, DA
Hockaday, A
Bird, J
Bowcock, S
Kaiser, M
de Tute, R
Rabin, N
Boyd, K
Jones, J
Parrish, C
Gardner, H
Meads, D
Dawkins, B
Olivier, C
Henderson, R
Best, P
Owen, R
Jenner, M
Kishore, B
Drayson, M
Jackson, G
Cook, G
Type
Journal Article
Metadata
Show full item recordAbstract
INTRODUCTION: Multiple myeloma is a bone marrow cancer, which predominantly affects older people. The incidence is increasing in an ageing population.Over the last 10 years, patient outcomes have improved. However, this is less apparent in older, less fit patients, who are ineligible for stem cell transplant. Research is required in this patient group, taking into account frailty and aiming to improve: treatment tolerability, clinical outcomes and quality of life. METHODS AND ANALYSIS: Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma is a national, phase III, multicentre, randomised controlled trial comparing standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide to lenalidomide+ixazomib, in patients with newly diagnosed multiple myeloma not suitable for stem cell transplant. Overall, 740 participants will be registered into the trial to allow 720 and 478 to be randomised at induction and maintenance, respectively.All participants will receive IRD induction with the dosing strategy randomised (1:1) at trial entry. Patients randomised to the standard, reactive arm will commence at the full dose followed by toxicity dependent reactive modifications. Patients randomised to the adaptive arm will commence at a dose level determined by their International Myeloma Working Group frailty score. Following 12 cycles of induction treatment, participants alive and progression free will undergo a second (double-blind) randomisation on a 1:1 basis to maintenance treatment with lenalidomide+placebo versus lenalidomide+ixazomib until disease progression or intolerance. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the North East-Tyne & Wear South Research Ethics Committee (19/NE/0125) and capacity and capability confirmed by local research and development departments for each participating centre prior to opening to recruitment. Participants are required to provide written informed consent prior to trial registration. Trial results will be disseminated by conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN17973108, NCT03720041.
Collections
Subject
CHEMOTHERAPY
Clinical trials
Myeloma
Aged
Clinical Trials, Phase III as Topic
Frailty
Humans
Lenalidomide
Multicenter Studies as Topic
Multiple Myeloma
Quality of Life
Randomized Controlled Trials as Topic
United Kingdom
Research team
Myeloma Biol Therap
Myeloma Molecular Therapy
Language
eng
Date accepted
2022-03-24
License start date
2022-06-02
Citation
BMJ Open, 2022, 12 (6), pp. e056147 -
Publisher
BMJ PUBLISHING GROUP
Except where otherwise noted, this item's license is described
as
http://creativecommons.org/licenses/by/4.0/
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