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)

3상 진행 중(모집 완료) NCT04162210

대상 질환Multiple Myeloma
임상 단계3상
스폰서GlaxoSmithKline
상태진행 중(모집 완료)
참여자 수325 명
중재(약물)Belantamab mafodotin, Pom/dex (Pomalidomide plus low dose Dexamethasone)
시작일2020년 4월 2일
완료일2022년 9월 12일
결과 공개일2023년 10월 6일

요약

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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