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埃罗妥珠单抗联合泊马度胺、卡非佐米和地塞米松治疗高危复发/难治性多发性骨髓瘤的疗效和安全性2期试验。

A phase 2 trial of the efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib and dexamethasone for high-risk relapsed/refractory multiple myeloma.

作者信息

Yashar David, Spektor Tanya M, Martinez Daisy, Ghermezi Matthew, Swift Regina A, Eades Benjamin, Schwartz Gary, Eshaghian Shahrooz, Lim Stephen, Vescio Robert, Berenson James R

机构信息

Institute for Myeloma & Bone Cancer Research, West Hollywood, CA, USA.

Harbor-UCLA Medical Center, Carson, CA, USA.

出版信息

Leuk Lymphoma. 2022 Apr;63(4):975-983. doi: 10.1080/10428194.2021.2005044. Epub 2021 Nov 24.

DOI:10.1080/10428194.2021.2005044
PMID:34818965
Abstract

High-risk multiple myeloma (MM) continues to have a poor prognosis and remains a therapeutic challenge. This phase 2 study evaluated the efficacy and safety of elotuzumab in combination with pomalidomide, carfilzomib, and low-dose dexamethasone for patients with high-risk relapsed/refractory (RR)MM (NCT03104270). Of 13 enrolled patients, 11 were evaluable for efficacy. Overall response rate and clinical benefit rate were 45.4% and 54.5%, respectively. Deep responses were observed including two complete responses. The novel quadruplet combination was overall well-tolerated, with clinically manageable adverse events. Common adverse events of ≥ grade 3 included lymphopenia (15%), anemia (15%), sepsis (15%), pneumonia (15%), and hypophosphatemia (15%). The novel combination showed promising efficacy and was well tolerated in this heavily pretreated MM population. Even though the study was terminated early prior to completion of enrollment, the results indicate that this may be a promising therapeutic approach for high-risk RRMM patients, which warrants further study.

摘要

高危多发性骨髓瘤(MM)的预后仍然很差,仍然是一个治疗挑战。这项2期研究评估了埃罗妥珠单抗联合泊马度胺、卡非佐米和低剂量地塞米松治疗高危复发/难治性(RR)MM患者的疗效和安全性(NCT03104270)。在13名入组患者中,11名可评估疗效。总缓解率和临床获益率分别为45.4%和54.5%。观察到深度缓解,包括2例完全缓解。这种新型四联组合总体耐受性良好,不良事件在临床上可管理。≥3级常见不良事件包括淋巴细胞减少(15%)、贫血(15%)、败血症(15%)、肺炎(15%)和低磷血症(15%)。这种新型组合在这个经过大量预处理的MM人群中显示出有前景的疗效且耐受性良好。尽管该研究在完成入组前提前终止,但结果表明这可能是高危RRMM患者一种有前景的治疗方法,值得进一步研究。

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