Myeloma XIV (FiTNEss)
Research type
Research Study
Full title
Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma: A phase III trial to compare standard and frailty-adjusted induction therapy with ixazomib, lenalidomide and dexamethasone (IRD) and maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I).
IRAS ID
234453
Contact name
Gordon Cook
Contact email
Sponsor organisation
University of Leeds
Eudract number
2018-003590-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Myeloma is a cancer diagnosed in around 5500 patients within the UK, each year. The development of treatments have increased life expectancy in all patients, but these have been less effective in older and frailer patients. There is no evidence to suggest their Myeloma is more aggressive, so it needs to be asked why this is the case.
Research is beginning to look at older Myeloma patients who are ineligible for transplants. Myeloma XI, a trial previous to this run at the CTRU, where 1840 of these patients were recruited, has shown that treatment outcomes were not necessarily associated with different combinations of treatment. Frailty-adjusted can potentially show how problems developed during treatment that are not responding effectively so it can be minimised.
All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to either frailty score-adjusted treatment vs.standard up-front treatment followed by toxicity dependen dose modifications during therapy. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation.
In the second phase of the trial, patients will be tested to assess whether lenalidomide and ixazomib is effective as a maintenance treatment. Patients will either receive lenalidomide and ixazomib, or lenalidomide and placebo (something that has a similar taste and appearance to ixazomib but has no effect on the person) to test this. Participants and their treating physicians will be blinded to maintenance allocation.
Aims: This trial aims to determine and compare:
a) Frailty adjusted dosing induction treatment compared to standard dosing induction treatment with modifications allowed where toxicity is seen
b)If there is an improved response rate and overall survival rate when patients receive lenalidomide plus ixazomib vs lenalidomide alone.Methods: A phase III, multi-centre, randomised controlled trial to compare standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with the novel triplet ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I) in patients with newly diagnosed multiple myeloma not suitable for a stem cell transplant.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0215
Date of REC Opinion
12 Aug 2019
REC opinion
Further Information Favourable Opinion