BENITIONSClinical Trial Intelligence

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

第3相 実施中(募集終了) NCT04162210

対象疾患Multiple Myeloma
第3相
スポンサーGlaxoSmithKline
ステータス実施中(募集終了)
参加者数325 名
介入(薬剤)Belantamab mafodotin, Pom/dex (Pomalidomide plus low dose Dexamethasone)
開始日2020年4月2日
完了日2022年9月12日
結果公開日2023年10月6日

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.

Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)

Up to 27 months · Months

Belantamab Mafodotin11.2 Months
Pomalidomide Plus Dexamethasone7.0 Months
p-value0.558
Hazard Ratio (HR)1.03 (95% CI 0.72–1.47)

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このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。