再発性または難治性多発性骨髄腫患者におけるAMG 701単独療法、またはポマリドミドとの併用療法（デキサメタゾンの有無にかかわらず）を評価する試験

基本情報

NCT ID

NCT03287908

ステータス

中止

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

174

治験依頼者名

Amgen

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)