More effective treatment options required for patients with MM post lenalidomide exposure

Dr Claudio Cerchione - IRCCS, Meldola, Italy

PREAMBLE is a multicentre international observational registry in which we collect data about relapsed/refractory multiple myeloma. It is of particular interest in the sub-analysis that we are presenting here at EHA 2024 about lenalidomide refractory patients. We know that the revolution in multiple myeloma is ongoing, there are many new drugs, many new combinations. However, for patients who become lenalidomide refractory we know that the outcome is not so brilliant. Particularly we know that lenalidomide is the standard of care in maintenance treatment and is in some way the backbone of standard of care of transplant ineligible front-line treatment. So we have currently potentially in second line an unmet medical need to cover.

In the PREAMBLE sub-analysis we have seen that for these patients the overall response rate is only 31%, independently from the drugs and combinations that we use. This means that we have to optimise the drugs and combinations that we have available in this setting, such as, for example, belamaf, bortezomib, dexamethasone that we have seen to show incredible results in the DREAMM-7 study, or selinexor, bortezomib, dexamethasone according to the BOSTON study. Because I think that we shall find a new potential standard of care in these patients in which we could in some way, we should, achieve the same results that we are going to see in other settings.

What is next for this study?

The next step is to increase the population for this registry. We are going to have more than thousands of patients. This analysis will cover about 1,000, more than 1,000 patients. The next steps will be to have another research question on this study to be capillary in understanding how today we could cover the unmet medical need in multiple myeloma. Because even if the revolution is going everywhere, we have some settings in which we could do more. This is the real endpoint of PREAMBLE and, moreover, we could understand how much the new cellular therapies, bispecific CAR T and also the cell modes could in some way change the recent, the present, outcomes for these patients and in particular for the relapsed and refractory population.

Analysing the real-world population can give us some information that we can not achieve in the same way from clinical trials.