A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Summary

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.

Timeline

Start

2017-11-13

Primary completion

2023-06-30

Completion

2023-06-30

Publications

• Lee HC, Plattel WJ, Harrison SJ, Sborov DW, Lentzsch S, Spencer A, Niesvizky R, Trudel S, Mollee P, Vij R, Minnema MC, Rasche L, Upreti VV, Zhou D, Xia Q, Talpes M, Eggert T, Kapoor P, Ailawadhi S. Phase 1/1b study of BCMA-targeting bispecific T-cell engager pavurutamab in relapsed/refractory multiple myeloma. Blood. 2026 Apr 8:blood.2025032044. doi: 10.1182/blood.2025032044. Online ahead of print.
• Cho SF, Lin L, Xing L, Li Y, Wen K, Yu T, Hsieh PA, Munshi N, Wahl J, Matthes K, Friedrich M, Arvedson T, Anderson KC, Tai YT. The immunomodulatory drugs lenalidomide and pomalidomide enhance the potency of AMG 701 in multiple myeloma preclinical models. Blood Adv. 2020 Sep 8;4(17):4195-4207. doi: 10.1182/bloodadvances.2020002524.

Drugs

Indications