The IMROZ trial is a large prospective randomised trial focussing in elderly patients with myeloma, those that were not eligible or did not want to receive high-dose therapy. So the patients were randomised to receive either VRd or the same combination with the addition of anti-CD38 monoclonal antibody isatuximab. The primary endpoint of the study was progression free survival which showed that it was significantly improved in favour of the isatuximab arm.

Furthermore, the depth of response, including minimal residual disease negativity, was markedly improved in favour of the isatuximab arm. The safety profile of the isatuximab VRd combination was acceptable, the side effects were essentially similar with sometimes a slightly higher rate of infections in the isatuximab arm. Also, preliminary analysis of overall survival shows a trend of favourable outcome in favour of the isatuximab arm.

What could be the clinical impact of these results?

The clinical impact is very significant because recently the FDA approved isatuximab, bortezomib, lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who are not eligible for high-dose therapy.