评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中的安全性和耐受性、药代动力学特征、以及有效性的Ⅰb期临床研究
[Translation] A phase Ib clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics, and efficacy of Besanostat combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma
1.评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中的安全性和耐受性;探索剂量限制性毒性(DLT)和最大耐受剂量(MTD);确定Ⅱ期推荐给药剂量(RP2D),为后续的临床研究提供依据。
2.评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中有效性,以及倍赛诺他和代谢物M1及伊沙佐米的药代动力学(PK)特征。
3.评价倍赛诺他片联合伊沙佐米和地塞米松治疗复发或难治性多发性骨髓瘤患者时的药效动力学(PD)特征,以及微小残留病(MRD)。
[Translation] 1. Evaluate the safety and tolerability of Besanostat tablets combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma; explore the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD); determine the recommended dose (RP2D) for phase II to provide a basis for subsequent clinical studies.
2. Evaluate the efficacy of Besanostat tablets combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma, as well as the pharmacokinetic (PK) characteristics of Besanostat and metabolites M1 and ixazomib.
3. Evaluate the pharmacodynamic (PD) characteristics of Besanostat tablets combined with ixazomib and dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma, as well as minimal residual disease (MRD).
倍赛诺他片在难治性或复发性多发性骨髓瘤患者中的耐受性、药代动力学及初步疗效评价
[Translation] Evaluation of the tolerability, pharmacokinetics and preliminary efficacy of Besanostat tablets in patients with refractory or relapsed multiple myeloma
1.观察倍赛诺他片的人体耐受性及安全性,确定剂量限制性毒性(DLT)及最大耐受剂量(MTD),为II期临床试验制定安全有效的给药方案提供依据; 2.初步考察倍赛诺他片在人体的单次给药、多次给药的药代动力学(PK); 3.初步评价倍赛诺他片治疗多发性骨髓瘤的疗效。
[Translation] 1. To observe the human tolerability and safety of Besanostat tablets, determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD), and provide a basis for formulating a safe and effective dosing regimen for Phase II clinical trials; 2. To preliminarily investigate the pharmacokinetics (PK) of Besanostat tablets in humans after single and multiple doses; 3. To preliminarily evaluate the efficacy of Besanostat tablets in the treatment of multiple myeloma.
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