Survival analysis of newly diagnosed transplant-eligible multiple myeloma patients in the randomised FORTE trial
Dr Francesca Gay - University of Torino, Torino, Italy
The FORTE trial is a randomised phase II study for newly diagnosed transplant eligible myeloma patients. The patients are randomised at the time of diagnosis into three induction and consolidation treatment arms. The first arm is carfilzomib, cyclophosphamide and dexamethasone – KCd induction, transplant and then KCd consolidation. The second arm is KRd induction, carfilzomib, lenalidomide, dexamethasone, autologous transplant and then KRd consolidation. The third arm is twelve cycles of KRd continuous treatment. After this therapy there is a second randomisation between maintenance with lenalidomide until progression, as per standard of care, or lenalidomide at the same dosing schedule given until progression but plus carfilzomib once every other week for up to two years.
The study and the data that have been reported at ASH this year evaluated the progression free survival after the first randomisation between the three induction and consolidation arms and the progression free survival after the second consolidation between the two maintenance arms. We found that patients had a significant benefit from up-front treatment in terms of progression free survival and sustained MRD negativity in those who were randomised to KRd, transplant and KRd consolidation. The same for maintenance – the significant benefit in terms of PFS was noticed for patients randomised to carfilzomib plus lenalidomide.
The studies are randomised phase II that was not blinded for both patients and for physicians. So each one of us knows the treatment that patients received.
What might the future impact of these results be on the treatment of multiple myeloma?
We confirmed the significant role of transplant in prolonging the progression free survival of patients, even in the context of newer therapies such as carfilzomib, lenalidomide and dexamethasone induction. We also found a new potential maintenance treatment that gives a combination of carfilzomib and lenalidomide that in our study improved significantly the progression free survival compared with lenalidomide alone that is the current standard of care.
Is there anything you would like to add?
These data need to be confirmed by longer follow-up and need to be probably evaluated in the context of all the available treatment regimens for newly diagnosed patients, including the recent role of monoclonal antibodies up front. Nevertheless, we found pretty interesting and encouraging results with these combinations up front and in the maintenance setting in all groups of patients, including patients with high risk that represents currently an unmet medical need.