NCT03445663

Study Evaluating AMG 424 in Subjects With Multiple Myeloma

A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 424 in Subjects With Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.

Detailed description

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.

Conditions

• Relapsed/ Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	AMG 424	Subjects will receive IV infusions of AMG 424

Timeline

• Start date: 2018-07-31
• Primary completion: 2020-06-19
• Completion: 2020-06-19
• First posted: 2018-02-26
• Last updated: 2023-03-07

Locations

8 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study