Alternate Day Dosing of Pomalidomide in Patients With Refractory Multiple Myeloma
Status:
Terminated
Trial end date:
2021-02-03
Target enrollment:
Participant gender:
Summary
Pomalidomide is an approved treatment for refractory multiple myeloma. Toxicity of
pomalidomide in the pivotal MM-003 trial, was considerable, with 60% of patients experiencing
drug-related G3/4 toxicity. Neutropenia (48% vs 16%) and pneumonia (13% vs 8%) were
significantly more common in the pomalidomide arm. This resulted in frequent dose
interruptions (67%) and dose reductions (27%). This suggests that for the majority of
patients the 4 mg daily dosing schedule is too toxic, and that strategies to deliver reduced
dosing of pomalidomide are of high practical relevance. The aim of this trial therefore is to
establish that alternate day dosing of pomalidomide (4 mg q2d, d1-28) is non-inferior to
daily dosing (4 mg d1-21 q28) in terms of efficacy of the drug with potentially less side
effects.