A Study of Subcutaneous (SC) AMG 701 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM)ProxiMMity-1
Study Details
A study to evaluate the safety and tolerability of subcutaneous (SC) AMG 701 in participants with relapsed or refractory multiple myeloma (RRMM) to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Protocol Summary
Number of participants who experience dose-limiting toxicities (DLTs)
Timeframe: 28 days
Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Timeframe: up to approximately 9 months
Number of participants who experience one or more treatment-related TEAEs
Timeframe: up to approximately 9 months
Number of participants with abnormal changes in vital signs
Timeframe: up to approximately 9 months
Number of participants with abnormal changes in electrocardiograms (ECGs) findings
Timeframe: up to approximately 9 months
Number of participants with abnormal changes in clinical laboratory tests
Timeframe: up to approximately 9 months
Maximum serum concentration (Cmax) of AMG 701
Timeframe: up to approximately 8 months
Time to maximum concentration (Tmax) of AMG 701
Timeframe: up to approximately 8 months
Area under the concentration-time curve (AUC) of AMG 701
Timeframe: up to approximately 8 months
Minimum concentration over the dosing interval (Ctrough) of AMG 701
Timeframe: up to approximately 8 months
Incidence of anti-AMG 701 antibody formation
Timeframe: up to approximately 9 months
Overall response (OR)
Timeframe: up to approximately 8 months
Best overall response (BOR)
Timeframe: up to approximately 8 months
Time to response
Timeframe: up to approximately 8 months
Duration of response (DOR)
Timeframe: up to approximately 8 months
Progression-free survival (PFS)
Timeframe: up to approximately 3 years
Overall survival (OS)
Timeframe: up to approximately 3 years