[Translation] A phase II, multi-cohort study evaluating daratumumab-containing therapy in subjects with light-chain (AL) amyloidosis
该研究旨在表征达雷妥尤单抗、环磷酰胺、硼替佐米和地塞米松(DVCd)不同治疗方案(A 组:达雷妥尤单抗+立即联合VCd 治疗,B 组:达
雷妥尤单抗+延后联合VCd 治疗)在新诊断的系统性AL 淀粉样变伴心脏受累患者中的心脏安全性,并确定心脏毒性的潜在风险防范策略(队列1);在
新诊断为系统性AL 淀粉样变且接受D-VCd治疗的少数人种和少数种族人群(包括黑人或非洲裔美国人受试者)中表征达雷妥尤单抗SC的药代动力学
(队列2)。
[Translation] The study aims to characterize the cardiac safety of different treatment regimens of daratumumab, cyclophosphamide, bortezomib, and dexamethasone (DVCd) (Arm A: daratumumab + immediate combined VCd treatment, Arm B: daratumumab + delayed combined VCd treatment) in patients with newly diagnosed systemic AL amyloidosis with cardiac involvement and to identify potential risk prevention strategies for cardiac toxicity (Cohort 1); to characterize the pharmacokinetics of daratumumab SC in racial and ethnic minority populations (including black or African American subjects) with newly diagnosed systemic AL amyloidosis receiving D-VCd (Cohort 2).