Dr Mateos presents results from a trial conducted by the Spanish Myeloma Group., suggesting a new standard of care. Patients with smouldering multiple myeloma at high risk of progression to symptomatic disease should be given lenalidomide (Revlimid) in combination with dexamethasone pre-emptively; to delay progression. Current treatment is to wait until progression occurs.

A significant benefit was observed in time to progression to symptomatic disease. Median time to progression on the no treatment arm was 25 months, and 28 out of the 60 patients included in this arm have already progressed to symptomatic disease. By contrast, in the len-dex arm only six patients progressed to symptomatic disease and the median time to progression has not been rated. The difference between these two arms is a statistical significance with a hazard ratio of 6.2.

After a median follow-up of 22 months, a benefit was observed in overall survival with a hazard ratio of approximately 6.7, indicating a prolongation in the overall survival for the patients receiving an LD treatment before moving to a symptomatic disease.

No grade 4 adverse events occurred; the frequency of grade 3 was very low and most of the side-effects observed, especially asthenia, skin rash infections, neutropenia, were at grade 1 or 2. During induction therapy and during maintenance therapy, giving lenalidomide as monotherapy and at low dose, only 10mg daily, toxicity profile was better with a very low frequency of side effects.

Talking at the International Myeloma Workshop, Paris, 5th May 2011.