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®).
STATUS
Actively recruiting
Recruitment updated as of Apr 2021
STUDY TITLE
Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM) – the FRAIL-M study
STUDY DESIGN
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).
CORRELATIVE STUDIES
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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
TIME FRAME
2019 – 2023
SITE LOCATIONS
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Alfred Hospital, VIC
Concord Hospital, NSW
Nepean Hospital, NSW
Tamworth Hospital, QLD
Toowoomba Hospital, QLD
PARTICIPANTS
300 newly diagnosed symptomatic multiple myeloma patients, 100 per frailty stratum
CURRENT ENROLMENT
19
STATUS
Recruiting