ASH 2013 - New Orleans, LA, USA

Benefit of lenalidomide and low-dose dexamethasone over standard therapy for multiple myeloma

Dr Thierry Facon - Centre Hospitalier Régional Universitaire de Lille, Lille, France

We established with others, but in France and as part of the IFM group, we established some years ago melphalan-prednisone-thalidomide as a standard of care for myeloma patients. So we did that five to ten years ago and based on an IFM study this regimen was approved in the EU. After that we took this very strong control arm and we investigated the efficacy and safety of lenalidomide in combination with low dose dexamethasone. Basically the conclusion of that study, which is a huge study in myeloma – 1,623 patients, so that’s the largest study ever done for registration in myeloma, we have approximately 1,000 patients receiving lenalidomide and low dose dex in that study and basically we were able to show that lenalidomide and low dose dex is a better regimen than MPT for PFIs, for all other secondary endpoints you can have in this kind of study, for overall survival as well. In terms of safety, in fact, the safety profile of this regimen is basically good so it’s totally in line with what we know from the safety profile of lenalidomide and dex because this combination is used in relapsed myeloma.

So this is a very manageable regimen. The good news is also that the incidence of secondary primary malignancy, especially haematological SPM was extremely low with lenalidomide and low dose dex and, as you know, we got some SPM in the past in some lenalidomide studies so the regimen is manageable, the regimen is safe and the regimen is associated with better efficacy results.

As a haematologist I would say that it has to be a new standard of care for transplant ineligible patients but, as you know, the registration decision is the decision of our colleagues in the regulatory agencies. But as a haematologist I would say that it is a new standard of care for myeloma patients.