Lenalidomide is a novel immunomodulatory agent with a unique dual mechanism of action: its tumoricidal effect leads to direct
tumor cell death, and its immunomodulatory effect keeps the
tumor in remission. Phase III clinical trials have demonstrated that in patients with relapsed/refractory
multiple myeloma (MM),
lenalidomide in combination with
dexamethasone offers high clinical response rates and improved time to
disease progression, progression-free survival (PFS), and overall survival (OS) compared with
dexamethasone alone. In patients with newly diagnosed MM, the combination of
lenalidomide and low-dose
dexamethasone prolonged survival compared with
lenalidomide and standard high-dose
dexamethasone. The benefits of
lenalidomide-based treatment regimens can be optimized by initiating treatment early in the disease course, either as a frontline treatment or at first relapse.
Lenalidomide is generally well tolerated; the primary adverse events are myelosuppression and venous thromboembolic complications. These adverse events emerge early in the course of treatment and can be managed using standard interventions such as
granulocyte colony-stimulating factor,
dose reduction, and thromboprophylaxis. The combination of
lenalidomide and
dexamethasone is effective and generally well tolerated in patients with renal impairment provided that
creatinine clearance level and adverse events are carefully monitored and the starting dose of
lenalidomide is adjusted appropriately. Early results from phase III trials indicate that in patients with newly diagnosed MM, continuous
lenalidomide therapy is well tolerated and associated with significant improvements in PFS, offering a new treatment option for patients with MM - although no OS benefit has yet been seen in this setting.
Lenalidomide-based treatment is effective across the spectrum of MM disease phases, allowing for the long-term management of myeloma.