The trial is designed to evaluate the benefit of Kyprolis administered once-weekly with dexamethasone versus the current FDA-approved twice-weekly administration schedule in patients who have received prior treatment with bortezomib and an immunomodulatory agent (IMiD).
The company began the Phase III trial based on the results from the Phase I/II Champion study, which evaluated 104 patients with relapsed or refractory multiple myeloma who had received one to three prior treatment regimens at the determined maximum tolerated dose (MTD) of 20/70mg/m2.
Amgen Research and Development executive vice-president Sean Harper said: "The results from the Champion Phase I/II study form the basis of the Phase 3 Arrow study with the goal of potentially providing patients and physicians greater convenience with a once-weekly dosing schedule of Kyprolis.
"The initiation of this trial underscores our commitment to addressing the needs of patients with multiple myeloma through the entire treatment continuum."
The Arrow trial will include around 460 patients with relapsed and refractory multiple myeloma who have received at least two but no more than three prior therapies, including bortezomib and an IMiD.
Patients in this trial will be given once-weekly Kyprolis (20mg/m2 on day 1 of cycle 1, 70mg/m2 on days 8 and 15 of cycle 1 and 70mg/m2 on days 1, 8 and 15 of subsequent cycles) with dexamethasone (40mg) versus twice-weekly Kyprolis (20mg/m2 on days 1 and 2 of cycle 1, 27mg/m2 on days 8, 9, 15 and 16 of cycle 1 and 27mg/m2 on days 1, 2, 8, 9, 15 and 16 of subsequent cycles) with dexamethasone (40mg).