复发性多发性骨髓瘤患者补救性自体干细胞移植前使用Plerixafor对干细胞动员的非介入研究(IFM-2015-03)。

Zoe van de Wyngaert, Florent Malard, Cyrille Hulin, Denis Caillot, Clara Mariette, Thierry Facon, Cyrille Touzeau, Aurore Perrot, Philippe Moreau, Benjamin Hebraud, Tarik Kanouni, Farhad Heshmati, Delphine Lebon, Mohamad Mohty, Christian Chabannon
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引用次数: 0

摘要

导言:尽管采用了新的治疗药物,但复发性多发性骨髓瘤(MM)的治疗仍然是一个挑战。补救性自体造血细胞移植(AHCT)仍然是一个有效的治疗选择,符合条件的患者获得长期的反应后,第一次AHCT。然而,第二次移植物并不总是可用的,这些患者可能需要第二次动员。患者和方法:根据法国的plerixafor标签,这项前瞻性、非介入性、多中心研究旨在收集利用基于plerixafor的造血细胞动员治疗复发性MM的挽救性AHCT可行性的数据。有资格接受第二次AHCT治疗的复发性MM成年患者,并使用粒细胞集落刺激因子(G-CSF)和普利沙福进行动员。结果:在23例患者中,17例实现了成功的造血细胞动员,13例能够进行第二次AHCT。中位年龄为62.9岁(最小-最大51-71岁)。男性10例(77%)。11例(85%)接受AHCT作为三线或更多的治疗。第一次和第二次AHCT之间的中位时间为5.4年(范围为2.6-16.3)。在18名可评估的患者中,17名(94%)患者的活动成功[95% CI 84-100],无副作用报道。在13例接受补救性AHCT的患者中,植入的中位时间为14天(最小-最大11-29天)。一年无进展生存率和总生存率分别为88.9% [95% CI 43.3-98.4]和100%。结论:本研究表明,哌利沙福可以安全有效地动员复发MM患者,这些患者是补救性AHCT的候选人。试验注册:NCT02439476 2015年5月8日注册,https://clinicaltrials.gov/ct2/show/NCT02439476。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Non-interventional Study Evaluating the Mobilization of Stem Cells by Plerixafor Before Salvage Autologous Stem Cell Transplant in Relapsed Multiple Myeloma (IFM-2015-03).

Introduction: Despite the implementation of new therapeutic agents, management of relapsed multiple myeloma (MM) remains a challenge. Salvage autologous hematopoietic cell transplant (AHCT) remains a valid therapeutic option for eligible patients who achieve prolonged response after a first AHCT. However, a second graft is not always available, and these patients may need a second mobilization.

Patients and methods: This prospective, non-interventional, multicenter study aimed to collect data on the feasibility of salvage AHCT using a plerixafor-based hematopoietic cell mobilization in relapsed MM, according to the plerixafor label in France. Adult patients with relapsed MM eligible for a second AHCT and mobilized using granulocyte- colony stimulating factor (G-CSF) and plerixafor were included.

Results: Of the 23 patients, 17 achieved a successful hematopoietic cell mobilization and 13 were able to proceed to a second AHCT. Median age was 62.9 years (min-max 51-71). Ten patients (77%) were male. Eleven (85%) received AHCT as a third-line treatment or more. Median time between first and second AHCT was 5.4 years (range, 2.6-16.3). Among 18 evaluable patients, mobilization was successful for 17 (94%) of them [95% CI 84-100], with no reported side effects. Among the 13 patients who underwent salvage AHCT, the median time to engraftment was 14 days (min-max 11-29). One-year progression-free and overall survival were 88.9% [95% CI 43.3-98.4] and 100%, respectively.

Conclusion: This study demonstrated that plerixafor allows safe and efficient mobilization in relapsed MM patients who are candidates for a salvage AHCT.

Trial registration: NCT02439476 Registered 8 May 2015, https://clinicaltrials.gov/ct2/show/NCT02439476 .

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