[Translation] DREAMM-10: A phase III, randomized, open-label study evaluating belantamab mafodotin in combination with lenalidomide and dexamethasone (BRd) versus daratumumab, lenalidomide, and dexamethasone (DRd) in subjects with newly diagnosed multiple myeloma (TI-NDMM) who are not eligible for autologous stem cell transplantation
主要目的:在 TI-NDMM 受试者中评价 BRd vs. DRd的临床活性;
关键次要目的:在 TI-NDMM 受试者中进一步评价 BRd vs. DRd 的临床有效性;
次要目的:在 TI-NDMM 受试者中评价 BRd vs. DRd的临床有效性;在 TI-NDMM 受试者中评价 BRd vs. DRd的安全性和耐受性;基于 TI-NDMM 受试者自我报告的症状性不良反应,评价研究治疗的安全性和耐受性;评价并比较 TI-NDMM 受试者的症状及其对功能和 HRQoL 影响的变化;在 TI-NDMM 受试者中表征 belantamab mafodotin 与来那度胺/地塞米松联合给药时 belantamab mafodotin 的暴露量;在 TI-NDMM 受试者中评估 BRd ADA
[Translation] Primary objective: To evaluate the clinical activity of BRd vs. DRd in TI-NDMM subjects;
Key secondary objectives: To further evaluate the clinical effectiveness of BRd vs. DRd in TI-NDMM subjects;
Secondary objectives: To evaluate the clinical effectiveness of BRd vs. DRd in TI-NDMM subjects; To evaluate the safety and tolerability of BRd vs. DRd in TI-NDMM subjects; To evaluate the safety and tolerability of study treatment based on self-reported symptomatic adverse reactions in TI-NDMM subjects; To evaluate and compare changes in symptoms and their effects on function and HRQoL in TI-NDMM subjects; To characterize the exposure of belantamab mafodotin when co-administered with lenalidomide/dexamethasone in TI-NDMM subjects; To evaluate the ADA of BRd in TI-NDMM subjects