The primary purpose of the phase 1 part of the study is to estimate the maximum tolerated dose (MTD) and/or a biologically active dose [I.e., Recommended phase 2 dose (RP2D)] and to confirm the safety and tolerability of the RP2D.
The dose-escalation part of the study will be conducted at multiple sites and test increasing doses and dosing schedules of AMG 701. This will be followed by Phase 1b dose confirmation and phase 2 dose expansion parts to gain further efficacy and safety experience with AMG 701.
The safety of subjects will be monitored by intensive assessments of vital signs, electrocardiograms, physical examinations, and laboratory tests.
Pathologically-documented diagnosis of multiple myeloma that is relapsed or refractory as defined by the following: