Replacement of ixazomib for relapsed/refractory multiple myeloma patients refractory to a bortezomib or carfilzomib-containing combination therapy.

作者：James R. Berenson, Alexa Cohen, Tanya M. Spektor, Jacob D. Bitran, Gigi Qiqi Chen, Mehdi M. Moezi, Alberto Bessudo, Joseph Z. Ye, Steven Hager, Robert A. Moss, Alan Cartmell, Teresa A. Coleman, John Hrom, Shahrooz Eshaghian, Tina Maluso, Regina A. Swift, Stephen Lim · 发表于：Journal of Clinical Oncology · 年份：2017 · DOI：10.1200/jco.2017.35.15_suppl.8013 · 被引用次数：11 · 研究领域：Multiple Myeloma Research and Treatments、Protein Degradation and Inhibitors、Chronic Lymphocytic Leukemia Research

8013 Background: The proteasome inhibitor (PI) ixazomib (Ixz) is the first orally administered PI approved for treating multiple myeloma (MM). It has shown clinical activity as a single agent and when used in other combinations. In this phase 1/2 trial, we evaluated Ixz as a replacement therapy for bortezomib or carfilzomib for MM patients who were refractory to a bortezomib- or carfilzomib-containing combination regimen. Methods: This was a phase 1/2, intra-patient, multicenter, open-label trial evaluating the replacement of ixazomib for bortezomib or carfilzomib for MM patients who were refractory in combination with the other agents that the patients had received and failed. Patients received Ixz on days 1, 8 and 15 on a 28-day schedule and the other drugs were administered using the same doses and schedules as they were receiving during their prior regimen. If the Ixz maximum tolerated dose (MTD) for a particular combination regimen was previously determined, then patients were enrolled directly into Phase 2 (PhII). If not, MTD was determined during the Phase 1 (PhI) portion of the trial. Results: To date, a total of 40 patients have been enrolled; 37 patients (21 were enrolled in PhI and 16 in PhII) had completed at least one cycle of this treatment. Patients received a median of 5 prior treatments (range, 1-22). The median follow-up time for all patients was 1.6 months (range, 0.1-10.7 months), whereas that of PhII was 2.2 months (range, 0.2-10.7 months). There was no c...