当前位置: X-MOL 学术Int. J. Hematol. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Daratumumab, lenalidomide, and dexamethasone in Japanese patients with transplant-ineligible newly diagnosed multiple myeloma: a phase 1b study.
International Journal of Hematology ( IF 1.7 ) Pub Date : 2020-01-30 , DOI: 10.1007/s12185-020-02825-w
Hiroyuki Takamatsu 1 , Shinsuke Iida 2 , Hirohiko Shibayama 3 , Kazuhiro Shibayama 4 , Hiroshi Yamazaki 4 , Kenshi Suzuki 5
Affiliation  

Lenalidomide and dexamethasone (Rd) treatment is common for patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem-cell transplantation. Daratumumab plus Rd (D-Rd) is effective and well tolerated for treating relapsed or refractory multiple myeloma. In this ongoing phase 1b trial, transplant-ineligible Japanese patients with NDMM received daratumumab (16 mg/kg intravenously every week for 8 weeks, every 2 weeks for 16 weeks, then every 4 weeks until disease progression) plus Rd (R 25 mg on Days 1‒21 of 28-day cycle; d 40 mg weekly). The primary objective was to evaluate D-Rd tolerability and safety in Japanese patients with NDMM. Secondary objectives included daratumumab pharmacokinetics and response rate. During the dose-limiting toxicity (DLT) evaluation period, two DLTs occurred in seven (28.6%) patients, indicating D-Rd tolerability. At an 11.0-month median follow-up (interim analysis), grade 3/4 treatment-emergent adverse events occurred in six (85.7%) patients, including lymphopenia (71.4%), leukopenia (57.1%), and neutropenia (42.9%). Three (42.9%) patients experienced infusion-related reactions (IRRs). All IRRs were grade 2, occurred during the first daratumumab infusion, and resolved within 24 h. Pharmacokinetic findings were comparable to those in previous studies. A 100% overall response rate was achieved. These findings suggest D-Rd is tolerable in Japanese patients with transplant-ineligible NDMM. ClinicalTrials.gov identifier NCT02918331.

中文翻译:

Daratumumab、来那度胺和地塞米松在日本不符合移植条件的新诊断多发性骨髓瘤患者中:一项 1b 期研究。

来那度胺和地塞米松 (Rd) 治疗对于不适合自体干细胞移植的新诊断多发性骨髓瘤 (NDMM) 患者很常见。Daratumumab plus Rd (D-Rd) 对治疗复发性或难治性多发性骨髓瘤有效且耐受性良好。在这项正在进行的 1b 期试验中,不符合移植条件的日本 NDMM 患者接受了 daratumumab(每周 16 mg/kg 静脉注射,持续 8 周,每 2 周持续 16 周,然后每 4 周直到疾病进展)加上 Rd(Rd 25 mg 28 天周期的第 1-21 天;每周 40 毫克)。主要目的是评估日本 NDMM 患者的 D-Rd 耐受性和安全性。次要目标包括达雷妥尤单抗药代动力学和反应率。在剂量限制毒性 (DLT) 评估期间,7 名 (28.6%) 患者发生了两次 DLT,表明 D-Rd 耐受性。在 11.0 个月的中位随访(中期分析)中,6 名 (85.7%) 患者发生 3/4 级治疗相关不良事件,包括淋巴细胞减少症 (71.4%)、白细胞减少症 (57.1%) 和中性粒细胞减少症 (42.9%) )。三名 (42.9%) 患者经历了输液相关反应 (IRR)。所有 IRR 均为 2 级,发生在第一次 daratumumab 输注期间,并在 24 小时内解决。药代动力学结果与以前的研究结果相当。实现了 100% 的总体响应率。这些发现表明 D-Rd 在日本移植不合格 NDMM 患者中是可以耐受的。ClinicalTrials.gov 标识符 NCT02918331。和中性粒细胞减少症(42.9%)。三名 (42.9%) 患者经历了输液相关反应 (IRR)。所有 IRR 均为 2 级,发生在第一次 daratumumab 输注期间,并在 24 小时内解决。药代动力学结果与以前的研究结果相当。实现了 100% 的总体响应率。这些发现表明 D-Rd 在日本移植不合格 NDMM 患者中是可以耐受的。ClinicalTrials.gov 标识符 NCT02918331。和中性粒细胞减少症(42.9%)。三名 (42.9%) 患者经历了输液相关反应 (IRR)。所有 IRR 均为 2 级,发生在第一次 daratumumab 输注期间,并在 24 小时内解决。药代动力学结果与以前的研究结果相当。实现了 100% 的总体响应率。这些发现表明 D-Rd 在日本移植不合格 NDMM 患者中是可以耐受的。ClinicalTrials.gov 标识符 NCT02918331。
更新日期:2020-04-21
down
wechat
bug