Dr. Costa on the Design of a First-in-Human Study With CC-93269 in R/R Myeloma

Luciano J. Costa, MD, PhD, an associate professor of medicine in the Blood and Marrow Transplantation and Cell Therapy Program at the University of Alabama's Birmingham School of Medicine, discusses the design of a phase 1 first-in-human study (NCT03486067) with CC-93269 in relapsed/refractory multiple myeloma.

The objective of this phase 1 trial, says Costa, was to access safety the safety of CC-93269 and determine the maximum tolerated dose, as well as the phase 2 dosein patients with relapsed/refractory multiple myeloma. The design of the study was such that patients received a weekly intravenous dose of the agent, which was given over 2 hours; that schedule took place over 3 cycles or 12 weeks. Subsequently, patients received the same dose (0.15 mg to 10 mg) every 2 weeks for 3 more cycles and then monthly afterward.

The initial cohorts, which consisted of 1 patient each, had a very low dose. Once the dose of 3 mg was reached, an additional 3 to 4 patients were accrued per cohort to receive the 10-mg dose. At that point, investigators also deployed an intrapatient step-up dose that started at 6 mg and went up to 10 mg in order to minimize toxicity, particularly cytokine release syndrome, which occurred in 77% of patients, concludes Costa.