The findings from this study will provide a robust framework for optimisation of treatment in improved survival and preservation of quality of life (QoL) for Transplant Ineligible Myeloma Patients.
This study also seeks to inform more cost-effective utilisation of publicy funded high-cost front-line anti-MM therapeutics such as Bortezomib (Velcade®) and Lenalidomide (Revlimid®).
Recruitment updated as of Jan 2021
Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM) – the FRAIL-M study
A randomised trial designed to identify which treatment options maximise efficacy whilst controlling toxicity below a certain threshold within each frailty stratum (fit, intermediate-fit and frail).
Measure minimal residual disease (MRD) negativity utilising high-sensitivity multi-parameter-flow cytometry (EuroFlow).
Characterise the mutations present in TI-NDMM patients failing treatment with lenalidomide utilising targeted amplicom sequencing (TAS) of cfDNA.
Evaluate the exRNA expression of cereblon and ikaros both at baseline and during the first week of treatment with lenalidomide utilising droplet digital (dd)PCR.
Characterise the peripheral blood immune profile of patients on treatment with lenalidomide utilising CyTOF.
TRIAL PRINCIPAL INVESTIGATOR
Professor Andrew Spencer
2019 – 2023
Alfred Hospital, VIC
Concord Hospital, NSW
Nepean Hospital, NSW
Tamworth Hospital, QLD
300 newly diagnosed symptomatic multiple myeloma patients, 100 per frailty stratum