The ALCYONE is a trial which was conducted for patients who were not eligible for high dose therapy, so mainly these were elderly patients with myeloma. The patients were randomised to receive either the combination of bortezomib melphalan and prednisone, VMP, which is the standard of care, one of the standards of care, for elderly patients with myeloma, or the same combination with the addition of the anti-CD38 monoclonal antibody daratumumab. In both groups VMP was given for a certain period of time and in the investigational arm patients continued with daratumumab. The main endpoint of the study was progression free survival and the first analysis met this endpoint with a very significant improvement of PFS in favour of VMP plus daratumumab. The median PFS with VMP alone was 18 months and the median PFS has not been reached for the investigational arm for a hazard ratio which was highly significant and 0.5. So this trial indicates that daratumumab in addition to VMP is a preferred treatment and is likely to become one of the new standards of care for patients with myeloma who are not eligible for high dose therapy.

How many patients were in the trial?

This was a very large trial that included more than 500 patients.

What about adverse effects?

The adverse events that occurred during the trial were mainly those due to the combination of VMP, that is peripheral neuropathy associated with bortezomib and myelosuppression associated with melphalan. The addition of daratumumab did not increase the side effect rate or severity.

So, to recap to a busy doctor watching this, what would be the take home message?

The take home message is that it’s very likely that daratumumab is moving to the front end treatment of patients with myeloma. We have this particular trial, there is another trial which is ongoing which compares lenalidomide dexamethasone with or without daratumumab. We will wait for the results of this trial which is very likely to be positive as well.