Abstract
toxicities, DLTs, multiple mieloma, MM
ONCOLOGY, RELAPSED/REFRACTORY MULTIPLE MYELOMA, REFRACTORY MULTIPLE MYELOMA
Previous studies showed antitumor activity for plitidepsin plus dexamethasone (DXM) in relapsed/refractory multiple myeloma (r/r MM), and in vitro synergism with bortezomib (BTZ) or DXM against MM cells. This phase I trial evaluated plitidepsin (3‐h intravenous infusion Day 1 and 15), BTZ (subcutaneous bolus Day 1, 4, 8, and 11), and DXM (orally Day 1, 8, 15, and 22), every 4 weeks in 36 r/r MM patients. Twenty‐two patients were treated using a standard dose escalation design (10 at the recommended dose [RD] cohort), and 14 additional patients were treated to expand the RD cohort. No dose‐limiting toxicities (DLTs) occurred during dose escalation. The highest dose level evaluated (plitidepsin 5.0 mg/mThis phase I trial evaluated antitumor activity for plitidepsin plus bortezomib (BTZ) and dexamethasone (DXM) in relapsed/refractory multiple mieloma patients (r/r MM). This triple combination of plitidepsin, BTZ, and DXM showed an acceptable safety profile and had moderate activity in adult patients with r/r MM that have failed to standard common therapeutic options, including BTZ and lenalidomide.
Preliminary results were presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting. “Ocio EM, Mateos M‐V, Prosper F, Martin J, Rocafiguera AO, Jarque I, et al. Phase I study of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Journal of Clinical Oncology. 2016;34(15_suppl): Abstract #8006.”