Perth Blood Institute’s (PBI) clinical trials team played an instrumental role in the publication of findings for an important multicentre, open-label, randomised phase 3 trial for relapsed multiple myeloma. The results of the study were published in the highly prestigious peer-reviewed journal, The Lancet. This is an outstanding achievement for the team and is extremely noteworthy as multiple myeloma is the second most common haematological malignancy in high-income countries.

This was a prospective, randomised clinical trial which followed patients for 3 years and involved 69 study centres in 16 countries across North and South America, Europe, and the Asia-Pacific region. 302 patients aged ≥18 years with relapsed or refractory (resistant to stimulus) multiple myeloma were included. Myeloma refers to type of blood cancer that develops in the bone marrow. The main aim of the study was for progression-free survival which refers to the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.

The study compared two therapies with 179 patients in the isatuximab with carfilzomib–dexamethasone (Isa-Kd) group which were compared to a control group of 123 patients taking carfilzomib-dexamethasone without isatuximab (Kd). At the 20.7-month follow-up, the results found that combining isatuximab with carfilzomib–dexamethasone substantially improves efficacy of the treatment and improvement in progression-free survival rate with a Hazard ratio of 0.53 which illustrates that half as many patients in the Isa-Kd group experienced an event compared to the control group at this stage in the trial.

There was a profound depth of response among patients in the Isa-Kd group which is a significant predictor for the long-term outcome of individuals with relapsed multiple myeloma. Another beneficial observation was that no safety signals were identified and the most common treatment related adverse event was infusion-related reactions. This therapy has demonstrated a manageable safety profile and favourable risk-benefit to patients. These results represent a new standard of care for this patient population.

The article was published June 4, 2021. The full article can be located at The Lancet website. 

The Perth Blood Institute (PBI) was established in 2013 and has grown to become one of the largest privately-funded haematology-focussed clinical research institutes within Western Australia. To find out more about the clinical trials at PBI go to the Clinical Trials page.

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Thursday, 24 June 2021