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Efficacy and safety of daratumumab in intermediate/high-risk smoldering multiple myeloma: final analysis of CENTAURUS
Blood ( IF 21.0 ) Pub Date : 2024-12-11 , DOI: 10.1182/blood.2024025897
Ola Landgren, Ajai Chari, Yael C. Cohen, Andrew Spencer, Peter M. Voorhees, Irwindeep Sandhu, Matthew W. Jenner, Dean Smith, Michele Cavo, Niels W. C. J. van de Donk, Meral Beksac, Philippe Moreau, Hartmut Goldschmidt, Diego Vieyra, Linlin Sha, Liang Li, Els Rousseau, Robyn Dennis, Robin Carson, Craig C. Hofmeister
Blood ( IF 21.0 ) Pub Date : 2024-12-11 , DOI: 10.1182/blood.2024025897
Ola Landgren, Ajai Chari, Yael C. Cohen, Andrew Spencer, Peter M. Voorhees, Irwindeep Sandhu, Matthew W. Jenner, Dean Smith, Michele Cavo, Niels W. C. J. van de Donk, Meral Beksac, Philippe Moreau, Hartmut Goldschmidt, Diego Vieyra, Linlin Sha, Liang Li, Els Rousseau, Robyn Dennis, Robin Carson, Craig C. Hofmeister
Early intervention of smoldering multiple myeloma (SMM) may delay progression to MM. Here, we present the final analysis of the phase 2 CENTAURUS study. In total, 123 patients with intermediate/high-risk SMM were randomized to IV daratumumab 16 mg/kg after a long-intense (n = 41), intermediate (n = 41), or short-intense (n = 41) dosing schedule. At a combined median follow-up of 85.2 months, in the long-intense, intermediate, and short-intense arms complete response or better rates were 4.9%, 9.8%, and 0%; overall response rates were 58.5%, 53.7%, and 37.5%; progressive disease/death rates were 0.096, 0.102, and 0.109 (P < .0001 for all arms); and median progression-free survival was not reached, 84.4, and 74.1 months, respectively. Median overall survival was not reached in any arm. Thirty-six patients in the long-intense or intermediate arms continued daratumumab in an optional extension phase after completing 20 cycles of per-protocol treatment. Median duration of study treatment was 44.0 (range, 1.0-91.6), 35.2 (range, 1.9-90.6), and 1.6 (range, 0.1-1.9) months in the long-intense, intermediate, and short-intense arms, respectively. No new safety signals were observed. With extended follow-up (median, ∼7 years), these data highlight the tolerability of daratumumab and support ongoing trials investigating daratumumab as an early intervention for SMM. This trial was registered at www.ClinicalTrials.gov as #NCT02316106.
中文翻译:
daratumumab 在中/高危冒烟型多发性骨髓瘤中的疗效和安全性:CENTAURUS 的最终分析
冒烟型多发性骨髓瘤 (SMM) 的早期干预可能会延缓进展为 MM。在这里,我们介绍了 2 期 CENTAURUS 研究的最终分析。总共有 123 名中/高危 SMM 患者在长期高强度 (n = 41)、中期 (n = 41) 或短期高强度 (n = 41) 给药方案后被随机分配至静脉注射 daratumumab 16 mg/kg。在中位随访 85.2 个月时,长期、中度和短期强度组的完全缓解或更好发生率为 4.9% 、 9.8% 和 0%;总体缓解率为 58.5% 、 53.7% 和 37.5%;疾病进展/死亡率分别为 0.096 、 0.102 和 0.109 (P < .0001 所有组);未达到中位无进展生存期,分别为 84.4 个月和 74.1 个月。任何组均未达到中位总生存期。长强度或中间组的 36 名患者在完成 20 个周期的按方案治疗后,在可选的扩展阶段继续使用 daratumumab。长期、中度和短期强度组的研究治疗的中位持续时间分别为 44.0 (范围,1.0-91.6)、35.2 (范围,1.9-90.6) 和 1.6 (范围,0.1-1.9) 个月。未观察到新的安全信号。随着随访时间的延长 (中位 ∼ 7 年),这些数据突出了 daratumumab 的耐受性,并支持正在进行的研究 daratumumab 作为 SMM 早期干预措施的试验。该试验在 www.ClinicalTrials.gov 注册为 #NCT02316106。
更新日期:2024-12-11
中文翻译:
daratumumab 在中/高危冒烟型多发性骨髓瘤中的疗效和安全性:CENTAURUS 的最终分析
冒烟型多发性骨髓瘤 (SMM) 的早期干预可能会延缓进展为 MM。在这里,我们介绍了 2 期 CENTAURUS 研究的最终分析。总共有 123 名中/高危 SMM 患者在长期高强度 (n = 41)、中期 (n = 41) 或短期高强度 (n = 41) 给药方案后被随机分配至静脉注射 daratumumab 16 mg/kg。在中位随访 85.2 个月时,长期、中度和短期强度组的完全缓解或更好发生率为 4.9% 、 9.8% 和 0%;总体缓解率为 58.5% 、 53.7% 和 37.5%;疾病进展/死亡率分别为 0.096 、 0.102 和 0.109 (P < .0001 所有组);未达到中位无进展生存期,分别为 84.4 个月和 74.1 个月。任何组均未达到中位总生存期。长强度或中间组的 36 名患者在完成 20 个周期的按方案治疗后,在可选的扩展阶段继续使用 daratumumab。长期、中度和短期强度组的研究治疗的中位持续时间分别为 44.0 (范围,1.0-91.6)、35.2 (范围,1.9-90.6) 和 1.6 (范围,0.1-1.9) 个月。未观察到新的安全信号。随着随访时间的延长 (中位 ∼ 7 年),这些数据突出了 daratumumab 的耐受性,并支持正在进行的研究 daratumumab 作为 SMM 早期干预措施的试验。该试验在 www.ClinicalTrials.gov 注册为 #NCT02316106。