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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Subjects will receive IV infusions of AMG 701.
Subjects will receive oral capsules of pomalidomide.
Subjects will receive IV injections or oral dexamethasone.
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences Myeloma Institute Slot 816
Little Rock, Arkansas, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Winship Cancer Institute Emory U
Atlanta, Georgia, United States
University of Chicago Medical Center - Multiple Myeloma Research Consortium
Chicago, Illinois, United States
Number of subjects with dose-limiting toxicities (DLTs)
Time frame: 28 days
Number of subjects with treatment emergent adverse events (TEAEs)
Time frame: 60 months
Number of subjects with treatment-related adverse events
Time frame: 60 months
Number of subjects with disease-related adverse events
Time frame: 60 months
Number of subjects with clinically-significant changes in vital signs
Time frame: 48 months
Number of subjects with clinically-significant changes in physical examination measurements
Time frame: 48 months
Number of subjects with clinically-significant changes in electrocardiogram (ECG) measurements
Time frame: 48 months
Number of subjects with clinically-significant changes in clinical laboratory tests
Time frame: 48 months
Pharmacokinetic parameter of AMG 701: Maximum concentration (Cmax)
Time frame: 12 weeks
Pharmacokinetic parameter of AMG 701: Time of maximum concentration (Tmax)
Time frame: 12 weeks
Pharmacokinetic parameter of AMG 701: Area under the concentration-time curve (AUC)
Time frame: 12 weeks
Pharmacokinetic parameter of AMG 701: Steady state concentration (Css)
Time frame: 12 weeks
Anti-tumor activity: Overall response rate
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Best overall response of stringent CR (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
Time frame: 48 months
Anti-tumor activity: Best overall response of stringent complete response (sCR)
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
Time frame: 48 months
Anti-tumor activity: Best overall response of complete response (CR)
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
Time frame: 48 months
Anti-tumor activity: Best overall response of very good partial response (VGPR)
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
Time frame: 48 months
Anti-tumor activity: Best overall response of partial response (PR)
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
Time frame: 48 months
Anti-tumor activity: Duration of response
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from the first PR or better to disease progression or death.
Time frame: 48 months
Anti-tumor activity: Time to response
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
Time frame: 48 months
Anti-tumor activity: Progression-free survival
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria. Defined as time from start of treatment until disease progression or death.
Time frame: 48 months
Anti-tumor activity: Overall survival
Defined as time from start of treatment until death due to any cause.
Time frame: 60 months
Anti-tumor activity: Number of subjects with minimum residual disease negative complete response
Efficacy parameter measured by International Myeloma Working Group (IMWG) response criteria.
Time frame: 48 months
Pharmacokinetic parameter of AMG 701: Trough concentration (Ctrough)
Time frame: 12 weeks
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
Hackensack, New Jersey, United States
...and 24 more locations