KEY TAKEAWAYS
- The FiTNEss, phase III trial will compare standard and frailty-adjusted induction therapy delivery and maintenance lenalidomide to lenalidomide+ixazomib in transplant non-eligible patients with newly diagnosed multiple myeloma (NDMM).
- It is a national, multicenter, randomized controlled trial with 740 participants, allowing for 720 and 478 to be randomized at induction and maintenance, respectively.
- This study aims to improve treatment tolerability, clinical outcomes, and quality of life for transplant non-eligible patients with newly diagnosed multiple myeloma.
The incidence of multiple myeloma in aging patients is increasing. Older patients unfit for stem cell transplants have worse outcomes despite overall improvements. The FiTNEss trial is a national, phase III, multicentre, randomized controlled trial to evaluate frailty-adjusted therapy’s effectiveness in this patient group. The trial will compare the standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with ixazomib, lenalidomide, and dexamethasone (IRD), and maintenance lenalidomide to lenalidomide+ixazomib. The experiment will have a total of 740 individuals, of whom 720 and 478 will be randomly assigned at the induction and maintenance phases, respectively. IRD induction will be administered to every participant using a randomization-based dosage technique.
Patients randomly assigned to the standard will begin the reactive arm at the complete dose and thereafter undergo toxicity-dependent reactive adjustments. Patients randomized to the adaptive arm will begin at a dose level determined by their International Myeloma Working Group frailty score. After 12 cycles of induction treatment, participants who are alive and progression-free will undergo a second randomization on a 1:1 basis to maintain treatment with lenalidomide+placebo versus lenalidomide+ixazomib until disease progression or intolerance.
The trial has received ethical approval from the North East-Tyne & Wear South Research Ethics Committee (19/NE/0125). Participants must provide written informed consent before registering for the trial. Results will be shared through conference presentations and peer-reviewed publications.
Source: https://pubmed.ncbi.nlm.nih.gov/35654466/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03720041/
Coulson AB, Royle KL, 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. 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. BMJ Open. 2022 Jun 2;12(6):e056147. doi: 10.1136/bmjopen-2021-056147. PMID: 35654466; PMCID: PMC9163533.
