再発性／難治性多発性骨髄腫（RRMM）患者を対象とした、ベランタマブ・マフォドチン単剤とポマリドミド＋低用量デキサメタゾン（Pom/Dex）の併用療法を比較する試験

基本情報

NCT ID

NCT04162210

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

325

治験依頼者名

GlaxoSmithKline

概要

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

対象疾患

介入

依頼者（Sponsor）