Lenalidomide (Revlimid®) is an immunomodulatory
drug with multiple mechanisms of action against
multiple myeloma. It is a
thalidomide analogue, with improved potency and reduced toxicity compared with
thalidomide. In the EU and USA,
lenalidomide monotherapy is indicated for the maintenance treatment of patients with newly diagnosed
multiple myeloma who have undergone autologous
stem-cell transplantation (ASCT). In the pivotal, phase 3 IFM 2005-02 and CALGB 100104 trials,
lenalidomide maintenance
therapy after ASCT administered until
disease progression significantly prolonged progression-free survival (PFS; primary endpoint) relative to placebo in patients with newly diagnosed
multiple myeloma. These results are generally supported by those of the phase 3 GIMEMA and Myeloma XI trials.
Lenalidomide maintenance
therapy significantly prolonged overall survival in CALGB 100104 but not in IFM 2005-02. However, a meta-analysis of patient-level data from IFM 2005-02, CALGB 100104 and GIMEMA showed an overall survival benefit with this
therapy.
Lenalidomide maintenance
therapy had a manageable tolerability profile in the pivotal trials. Grade 3/4 haematological adverse events and grade 3 nonhaematological adverse events were more common with
lenalidomide than with placebo.
Lenalidomide increased the risk of a
second primary cancer, but the survival benefits outweigh this risk. In conclusion,
lenalidomide maintenance
therapy after ASCT until
disease progression prolongs PFS and overall survival in patients with newly diagnosed
multiple myeloma. Therefore,
lenalidomide offers a valuable maintenance treatment option for this population.