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 May 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
-
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
-
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
24
STATUS
Recruiting