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

Ishibashi Hideyasu0 个研究点目标入组 20 人开始时间: 2022年2月1日最近更新: 2023年11月20日

适应症

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.

发起方

Ishibashi Hideyasu