AMaRC: FRAIL-M

Topics:ACTA Members

The Australasian Myeloma Research Consortium (AMaRC) is dedicated to helping patients with myeloma—a rare blood cancer which currently has no cure.

Current myeloma therapies are based on research involving younger demographics, but myeloma generally affects people over 50 years of age. To address this, AMaRC has developed the FRAIL-M randomised controlled trial to identify which competing treatment options are more appropriate in transplant-ineligible myeloma patients according to frailty status.

Ms Christine Quek, AMaRC clinical project manager, says that by comparing the two drugs Revlimid and Velcade, the trial aims to not only assess which treatment is most effective for patients, but also contribute to existing data towards bigger, phase III studies in the future.

“So far in Australia we’re doing pretty well. The survival rate is improving but patients tend to relapse. The period between relapsing is actually getting longer, so I think the therapies are improving and experts are increasingly knowledgeable. At least there are options now to get more therapies for people—one size doesn’t fit all, so we’re hoping to get more tailored and individualised therapies.” Said Ms Quek.

The trial was granted $1.5M in MRFF funding in November last year and has been running for six months. Because Myeloma is a rare disease, recruitment has been fairly slow. In addition to existing recruitment problems due to the uncommon nature of the disease, COVID-19 has slowed recruitment even further, as clinical trial sites are placed under increased pressure and can’t actively participate in trial recruitment.

That said, the PBS recently approved the Revlimid and Velcade combination, which has increased enthusiasm from sites. The PBS approval has meant that there are less supply issues, and sites are open to expressing an interest in becoming partners. This is an imperative step toward tangible results—given the uncommon nature of Myeloma, participation from more sites is important to gain the best results.

While the primary output of the FRAIL-M study is a comparative analysis of two therapies, the study also focuses on quality of life for patients. By using a structured questionnaire that has been developed and tested in collaboration with consumers, the study aims to find which therapy contributes to greater perceived patient quality of life. Through these results, the team at AMaRC hopes to find more tangible outcomes for patients.

According to Ms Quek, the team also hopes to incorporate a virtual trial element in the future.

“Myeloma patients are generally elderly so what we’re finding is that there are a lot of patients living in rural or remote areas, so we have tried to incorporate telehealth, but because it’s a novel thing it’s been quite difficult to get that up and running. But hopefully post-COVID-19 telehealth will be more prominent, and it’ll be much easier to incorporate that into future trials.”

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Lab studies for myeloma patients

Given the infrequency of diagnosis in Australia, in addition to clinical studies, patients may be recruited for laboratory testing.

“With myeloma we do correlative studies, so we do lab stuff as well. It’s a bit more rigorous because there’s a lot more blood samples involved for the patient, but that does go a long way with helping us understand the disease and find therapies that may work.” Said Ms Quek.