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Multiple myeloma MM is among the most frequent hematologic malignancies. Despite recent treatment advances, MM remains an incurable disease in the vast majority of cases. The course of the disease is characterized by multiple relapses. Pomalidomide is a third-generation, oral immunomodulatory drug with activity in patients with relapsed and refractory MM. The drug costs of pomalidomide are high even for healthcare systems in developed countries Switzerland: Obviously, this requires that pomalidomide has adequate pharmacokinetic properties.
The evidence supporting the established vs alternative dosing schedules of pomalidomide is, therefore, worth reconsidering. In a population pharmacokinetics analysis, Li et al. As a result, the decline of the plasma concentration at the terminal phase was slow Figure 1. These data make pomalidomide an ideal candidate for alternate day dosing.
Individual dose-normalized pomalidomide concentration vs time profiles: healthy normal participants vs patients with MM 3. The early dose-finding studies with pomalidomide resulted in conflicting data. Schey et al.
The main objective of the study was to establish the maximum tolerated dose MTD of pomalidomide. Because of the toxicities observed, the same group undertook a second dose-finding phase 1 study using alternate day administration with the aim to potentially reduce toxicity while maintaining efficacy.
