A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8)

GlaxoSmithKline K.K.0 个研究点目标入组 20 人开始时间: 2022年3月8日最近更新: 2024年7月13日

试验速览

暂无简介。

•18 years or older (at the time consent is obtained)
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
•Have undergone autologous stem cell transplant (SCT) or are considered transplant ineligible.
•Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen (lenalidomide must have been administered for at least 2 consecutive cycles) and must have documented disease progression during or after their most recent therapy.
•Adequate organ system functions as defined by the laboratory assessments listed in study protocol

•Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis,
•active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal
•plasma proliferative disorder, and skin changes).
•Systemic anti-myeloma therapy (including chemotherapy and systemic steroids)
•or use of an investigational drug within 14 days or five half-lives (whichever is shorter)
•preceding the first dose of study drug; Prior treatment with a monoclonal antibody drug
•within 30 days of receiving the first dose of study drugs.
•Received prior treatment with or intolerant to pomalidomide
•Received prior BCMA targeted therapy
•Plasmapheresis within 7 days prior to the first dose of study drug.
•Participants after prior allogeneic SCT.

Progression-free Survival (PFS)

defined as the time from the date of randomization until the earliest date of documented disease progression or death due to any cause

未报告次要终点

发起方

GlaxoSmithKline K.K.