A new standard of care for elderly people with multiple myeloma

Professor Hang Quach, Director of Haematology at St Vincent’s Hospital Melbourne and MAIA study investigator.

Researchers at St Vincent’s Hospital Melbourne (SVHM) have participated in a new clinical trial exploring a treatment combination that can result in longer, progression free survival for elderly people with multiple myeloma.

The MAIA study is a pivotal phase 3 clinical trial that is helping establish a new standard of care for these patients.

SVHM has been involved in the trial since January 2016, and was the lead ethic site for Australia

Going beyond the standard of care

In Australia, the current standard of care for the treatment of elderly people with myeloma is a two-drug combination, containing lenalidomide and dexamethasone.

For younger patients, who don’t have substantial coexisting conditions, treatment can include high-dose chemotherapy and stem-cell transplantation. However, age and the presence of coexisting conditions, can limit elderly patients from such treatment options.

The MAIA study sought to determine if the addition of a third drug, daratumumab, could significantly reduce the risk of disease progression or death in this population. This was done by comparing a three drug combination (daratumumab, lenalidomide and dexamethasone) to the original two-drug combination (lenalidomide and dexamethasone).

“Clinical trials give patients access to treatment options beyond what is available as the standard of care – they can provide lifesaving agents for people who have exhausted all other treatment options,” said Professor Hang Quach, Director of Haematology at St Vincent’s Hospital Melbourne and MAIA study investigator.

“SVHM has the one of the largest haematology clinical trials unit in Australia, with more than 130 active clinical trials currently recruiting, and this allows us to provide more personalised treatment options to patients who may otherwise not have access to the most effective treatment for their specific disease.

“Clinical trials have three phases – the first phase tests the trial’s safety, the second phase tests for more safety and efficacy and then the third phase is about finding a treatment that is better than the current standard of care.

“As a Phase 3 trial, the MAIA study sought to achieve progression-free survival (the time it takes for myeloma to come back), with the secondary goal of delaying time to progression.”

A world-wide collaboration to improve patient outcomes

More than 730 patients, from 176 hospitals in 14 countries across North America, Europe, the Middle East and the Asia-Pacific region participated in the MAIA trial. Patients were aged 18 years or older and had newly diagnosed multiple myeloma. None of the participants who took part in the study had been treated before or were eligible to receive stem-cell transplants.

Patients’ cancer was monitored for improvement, worsening or no change. Thus far, patients have been followed for a median of over six years. Patients are followed up for survival status indefinitely.

Another chance at an effective treatment

The study demonstrated that the three-drug combination was superior to the two-drug combination, resulting in longer, progression-free survival and overall survival time.

“The risk of disease progression or death was 47% lower in the patients who received the three-drug combination, than in the control group,” explained Professor Quach.

Based on MAIA study, the three-drug combination has become the standard of care for these patients in the USA and Europe. In Australia, the treatment has received approval by the Therapeutic Goods Association but is not reimbursed by the Pharmaceutical Benefit Scheme, making it challenging and costly for Australians to access. 

“The MAIA study means that patients who would otherwise have not been able to access this treatment option now can, and for patients responded positively to the new treatment can continue receiving this treatment until the occurrence of disease progression or unacceptable side effects.”

The initial results of the MAIA study were published in Lancet Oncology in 2021 showing that the three-drug combination significantly improved overall survival (relative risk reduction of 32%) and progression free survival (relative risk reduction of 47%) compared to the two-drug treatment. The results were further updated in January 2022, with SVHM investigator Hang Quach listed on the authorship of both these publications.

To read more about haematology clinical trials at St Vincent’s Hospital Melbourne, please visit our website.