Discussion
venous and arterial thromboembolism, diarrhea, cytopenias, ’s 2 stage, hypokalemia
MULTIPLE MYELOMA, TERATOGENESIS, CYTOPENIAS, RECRUITMENT, ONCOLOGY, MYELOMA, BROWN
While lenalidomide, bortezomib, and dexamethasone (RVD), with the addition or substitution of daratumumab in recent years, is the preferred initial treatment for most patients with newly diagnosed multiple myeloma, there are several alternative options that may be of benefit to select patient subgroups. Lenalidomide is associated with significant risk of teratogenesis as well as diarrhea, cytopenias, hypokalemia, and an increased risk of venous and arterial thromboembolism.In this phase II Brown University Oncology Research Group trial, we investigated the effectiveness of an all-oral regimen of ixazomib, cyclophosphamide, and dexamethasone with the use of metronomic cyclophosphamide dosing in the treatment of patients with newly diagnosed multiple myeloma. Daily cyclophosphamide dosing, known as metronomic dosing, has been evaluated in several prior studies showing clinical response.Simon’s 2 stage (MiniMax) design was used to evaluate response. Responses were determined using the 2016 IMWG response criteria and derived from the consensus guidelines for the uniform reporting of myeloma clinical trials.(The study was terminated due to slow recruitment but with a total of 12 patients treated. Response rates and survival were below those seen in similar studies as well as below standard of care options, with only 16.7% of patients obtaining a very good partial response (VGPR) and a median progression-free survival (PFS) of 16 months (