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®).
FRAIL-M is recruiting in both Australia and New Zealand
STATUS
Actively recruiting
CURRENT ENROLMENT
57 patients
Recruitment updated as of Dec 2021
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).
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Characterise the mutations present in TI-NDMM patients failing treatment with lenalidomide utilising targeted amplicom sequencing (TAS) of cfDNA.
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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.
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Characterise the peripheral blood immune profile of patients on treatment with lenalidomide utilising CyTOF.
TRIAL PRINCIPAL INVESTIGATOR
Professor Andrew Spencer
TIME FRAME
2019 – 2023
PARTICIPANTS
Newly diagnosed multiple myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant
SITE LOCATIONS
AUSTRALIA
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Alfred Hospital, VIC
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Latrobe Hospital, VIC
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Concord Hospital, NSW
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Nepean Hospital, NSW
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Tamworth Hospital, NSW
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Toowoomba Hospital, QLD
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Northern Hospital, VIC
NEW ZEALAND
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Middlemore Hospital, Auckland
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Dunedin Hospital, Dunedin
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North Shore Hospital, Auckland