CyBorD, which is a combination of Cytoxan, bortezomib and dexamethasone is widely used in the US community centres as an induction treatment for front line treatment of our patients with multiple myeloma. We have the first line data from Europe adding daratumumab to VMP improved progression free survival but melphalan is not used in the US that much so we wanted to see if we added daratumumab to CyBorD, which is a commonly used regimen, can we improve outcomes in these patients.
That’s the background why we did this phase II study, single arm study, enrolling 101 patients. 87 patients were newly diagnosed and we had a small number of patients who were first relapse multiple myeloma patients. That arm was closed early because of poor accrual so we will focus on the newly diagnosed patients when we go through the results.
What we found is when we looked at the primary endpoint of the study is VGPR, very good partial response, or better after four cycles of induction treatment and there are other secondary endpoints which include progression free survival, overall survival. So the VGPR or better after four cycles of induction was about 44% with an overall response rate of 79% in the newly diagnosed multiple myeloma patients. With a longer follow up, 18 month progression free survival was about 79% in all comers but when we looked closely at the non-transplant multiple myeloma patients it was 78% which is similar or slightly better than the daratumumab VMP study in the ALCYONE trial from Europe.
What are the implications?
Daratumumab is now being combined with RVd which seems to be a better backbone regimen and all patients with newly diagnosed multiple myeloma are able to receive Revlimid treatment. So our study which shows a thorough progression free survival will overall in treating these patients, especially if they are not a candidate for Revlimid-based treatment, if they present with renal failure or if they can’t tolerate it, that would be where I will use it.