A Study to Assess AMG 701 Montherapy, or in Combination with Pomalidomide, with or without, Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
Study Details
The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will include a sequential dose exploration part to identify the RP2D of AMG 701 in combination with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of the dose-expansion part to gain further efficacy and safety experience with AMG 701 monotherapy in adult subjects with RRMM.
Protocol Summary
Number of subjects with dose-limiting toxicities (DLTs)
Timeframe: 28 days
Number of subjects with treatment emergent adverse events (TEAEs)
Timeframe: 60 months
Number of subjects with treatment-related adverse events
Timeframe: 60 months
Number of subjects with disease-related adverse events
Timeframe: 60 months
Number of subjects with clinically-significant changes in vital signs
Timeframe: 48 months
Number of subjects with clinically-significant changes in physical examination measurements
Timeframe: 48 months
Number of subjects with clinically-significant changes in electrocardiogram (ECG) measurements
Timeframe: 48 months
Number of subjects with clinically-significant changes in clinical laboratory tests
Timeframe: 48 months
Pharmacokinetic parameter of AMG 701: Maximum concentration (Cmax)
Timeframe: 12 weeks
Pharmacokinetic parameter of AMG 701: Time of maximum concentration (Tmax)
Timeframe: 12 weeks
Pharmacokinetic parameter of AMG 701: Area under the concentration-time curve (AUC)
Timeframe: 12 weeks
Pharmacokinetic parameter of AMG 701: Steady state concentration (Css)
Timeframe: 12 weeks
Anti-tumor activity: Overall response rate
Timeframe: 48 months
Anti-tumor activity: Best overall response of stringent complete response (sCR)
Timeframe: 48 months
Anti-tumor activity: Best overall response of complete response (CR)
Timeframe: 48 months
Anti-tumor activity: Best overall response of very good partial response (VGPR)
Timeframe: 48 months
Anti-tumor activity: Best overall response of partial response (PR)
Timeframe: 48 months
Anti-tumor activity: Duration of response
Timeframe: 48 months
Anti-tumor activity: Time to response
Timeframe: 48 months
Anti-tumor activity: Progression-free survival
Timeframe: 48 months
Anti-tumor activity: Overall survival
Timeframe: 60 months
Anti-tumor activity: Number of subjects with minimum residual disease negative complete response
Timeframe: 48 months
Pharmacokinetic parameter of AMG 701: Trough concentration (Ctrough)
Timeframe: 12 weeks