icon-facebookicon-instagramicon-pinteresticon-soundcloudicon-twittericon-youtube
AMaRC 19-01 - STUDY TITLE: Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM) – the FRAIL-M study

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

82 patients

Recruitment updated as of September 2022

 

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

 

PARTICIPANTS

Newly diagnosed multiple myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant 

 

SITE LOCATIONS

AUSTRALIA

 

NEW ZEALAND