Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
3期
进行中(已停止招募)
NCT04162210
| 适应症 | Multiple Myeloma |
|---|
| 分期 | 3期 |
|---|
| 申办方 | GlaxoSmithKline |
|---|
| 状态 | 进行中(已停止招募) |
|---|
| 受试者人数 | 325 人 |
|---|
| 干预(药物) | Belantamab mafodotin, Pom/dex (Pomalidomide plus low dose Dexamethasone) |
|---|
| 开始日期 | 2020年4月2日 |
|---|
| 完成日期 | 2022年9月12日 |
|---|
| 结果公布日 | 2023年10月6日 |
|---|
摘要
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 Mafodotin | 11.2 Months |
|---|
| Pomalidomide Plus Dexamethasone | 7.0 Months |
|---|
| p-value | 0.558 |
| Hazard Ratio (HR) | 1.03 (95% CI 0.72–1.47) |
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
同一适应症的其他试验
全部试验
本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。