A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.
Part 1 of the study is dose evaluating and aimed at assessing the safety and tolerability of AMG 424 while determining the maximum tolerated dose (MTD) and/or biologically active dose in subjects with relapsed/ refractory multiple myeloma. Part 2 of the study will further evaluate safety and tolerability of the AMG 424 MTD dose determined in Part 1, in groups of subjects with relapsed/ refractory multiple myeloma that include those with high or low cytogenetic risk.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Subjects will receive IV infusions of AMG 424
Research Site
San Francisco, California, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Subject incidence of treatment emergent and treatment related adverse events as assessed by CTCAE version 4.0
Measure of Safety
Time frame: 12 Months
Subject incidence of dose limiting toxicities (DLTs)
Measure of Safety
Time frame: 28 Days
Anti-tumor activity
Efficacy parameter measured by IMWG response criteria
Time frame: 48 Months
Duration of Response
Measure of Response
Time frame: 48 Months
Maximum concentration (Cmax) of AMG 424
Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
Time frame: 12 Weeks
Minimum concentration (Cmin) of AMG 424
Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
Time frame: 12 Weeks
Time of maximum concentration (Tmax) of AMG 424
Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
Time frame: 12 Weeks
Area under the concentration-time curve (AUC) of AMG 424
Characterize the pharmacokinetic (PK) profile following treatment with AMG 424
Time frame: 12 Weeks
Time to progression
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Research Site
Seattle, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Fitzroy, Victoria, Australia
Measure of Response
Time frame: 48 Months
Progression-Free Survival
Measure of Response
Time frame: 48 Months
Overall Survival
Measure of Response
Time frame: 48 Months