SYSTEMATIC REVIEW article
Front. Oncol.
Sec. Hematologic Malignancies
This article is part of the Research TopicImmunity and Immunotherapy in Multiple MyelomaView all articles
Infection Risks Associated with Daratumumab-Containing Regimens in Multiple Myeloma: A Systematic Review and Meta-Analysis
Provisionally accepted
- 1Faculty of Chinese Medicine, Macau University of Science and Technolog, Macau, China
- 2The People’s Hospital of Gaozhou, Gaozhou, China
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Daratumumab, a CD38-targeting monoclonal antibody, is a key component of therapy for both newly diagnosed and relapsed or refractory multiple myeloma. By depleting CD38-expressing immune effector cells and reducing immunoglobulin levels, daratumumab may increase susceptibility to infections. To quantify this risk, we performed a systematic review and meta-analysis of randomized phase II and III trials comparing daratumumab-containing regimens with standard therapies in adults with multiple myeloma. Databases including PubMed, Embase, Web of Science, the Cochrane Library, and ClinicalTrials.gov were searched through 14 October 2025, following PRISMA 2020 guidelines. Nine trials encompassing 5,281 patients were included. Daratumumab-based regimens were associated with an increased risk of any infection (risk ratio [RR] 1.23; 95% confidence interval [CI] 1.14–1.33), grade ≥3 infection (RR 1.29; 95% CI 1.17–1.42), and pneumonia (RR 1.60; 95% CI 1.24–2.07). Subgroup analyses showed consistent results across disease stages and transplant eligibility groups. Infection-related mortality was uncommon (≤2%) and did not differ significantly between arms. These findings indicate that daratumumab-based therapy increases infection risk, particularly for severe infections and pneumonia, but the absolute mortality remains low. Proactive infection prevention and close clinical monitoring are warranted as the use of daratumumab continues to expand. This study was prospectively registered in PROSPERO (CRD420251165266).
Keywords: Multiple Myeloma, Daratumumab, Infection, Pneumonia, Meta-analysis, randomized controlled trials
Received: 22 Oct 2025; Accepted: 05 Dec 2025.
Copyright: © 2025 Huang, Liu, Li and Luo. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xiao-Lian Liu
Ting Li
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