Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study
| Autor: | Steven Sun, Weiping Liu, Gang An, Zhen Cai, Ming Qi, Lijuan Chen, Wei Li, Xue Yang, Xue Gai, Zheng Ge, Yafei Wang, Jin Lu, Ting Niu, Xi-Nan Cen, Chengcheng Fu, Jie Jin, Xiao-Jun Huang, Wenyu Liu, Jianda Hu, Weijun Fu |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty China Gastroenterology Dexamethasone Bortezomib Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Aged business.industry Hazard ratio Daratumumab Antibodies Monoclonal Refractory Multiple Myeloma Hematology Middle Aged Interim analysis Confidence interval Oncology Female Neoplasm Recurrence Local business Multiple Myeloma medicine.drug |
| Zdroj: | Clinical lymphoma, myelomaleukemia. 21(9) |
| ISSN: | 2152-2669 |
| Popis: | Background Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 CASTOR study. We report the results of a prespecified interim analysis of the phase 3 LEPUS study of D-Vd versus Vd in Chinese patients with RRMM. Patients and Methods Chinese patients with ≥ 1 prior line of therapy were randomized 2:1 to receive 8 cycles (21 days/cycle) of bortezomib (1.3 mg/m2 subcutaneously) and dexamethasone (20 mg orally/intravenously) ± daratumumab (16 mg/kg intravenously). The primary endpoint was progression-free survival (PFS). Results A total of 211 patients were randomized (D-Vd, 141; Vd, 70). After an 8.2-month median follow-up, D-Vd significantly prolonged PFS versus Vd (median, not reached vs. 6.3 months; hazard ratio, 0.28; 95% confidence interval, 0.17-0.47; P Conclusion These data support the use of D-Vd in Chinese patients with RRMM. |
| Databáze: | OpenAIRE |
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