Temporal trends in infectious risk among multiple myeloma patients treated with daratumumab: A meta-analysis
In brief
Daratumumab raises severe infection rates from 20% to 29% over two years
Across six randomized trials involving 2,989 patients, severe infections occurred in 29% of those receiving daratumumab, compared with 20% of controls. Infection rates peaked in the first three months, and recurrent infections were also more common; fewer than 20% of patients with severe respiratory infections received immunoglobulin replacement. The findings point to an early window for closer monitoring, but the best prevention strategy remains unclear.
- Journal
- British journal of haematology (Q1)
- Published
- 26 October 2026
- Study design
- Systematic review / meta-analysis of RCTs
- Evidence level
- Level 1, High (CEBM 1a)
- Authors
- Alissa Visram, Hira Mian, James Lee, Aaron Jones, Gregory R Pond, Doris Hansen, et al.
- PMID
- 42928979
- DOI
- 10.1111/bjh.70882
Why clinicians should know about it
- Picked for Hematology (paper of the day, 28 October 2026): Randomized-trial meta-analysis quantifies infection risk with myeloma daratumumab
Abstract
Anti-cluster of differentiation 38 (Anti-CD38) monoclonal antibodies such as daratumumab are widely used in multiple myeloma (MM), yet the timing and magnitude of infectious risk remain incompletely defined. We performed an individual patient-level meta-analysis of six randomized trials (N = 2989) comparing daratumumab- versus non-daratumumab-containing regimens in newly diagnosed and relapsed/refractory MM, assessing infectious events over 2 years. Daratumumab-treated patients had higher rates of any-grade (79% vs. 61%) and grade ≥3 infections (29% vs. 20%) than controls, with risk peaking in the first 3 months (42% vs. 36%, p = 0.001) before plateauing. After adjustment, daratumumab was independently associated with grade ≥1 (odds ratio [OR] 1.31, 95% confidence interval [CI] 1.10-1.57), respiratory (OR 1.38, 95% CI 1.11-1.71) and grade ≥3 (OR 1.47, 95% CI 1.08-2.00) infection by 3 months. Daratumumab-treated patients had a higher rate of infection over 2 years (adjusted incidence rate ratio 1.60, 95% CI 1.47-1.73) and more frequently experienced recurrent infections (33% vs. 22% with multiple any-grade infections; 11% vs. 7% with multiple grade ≥3 infections). Preventive strategies were underused, with <20% of patients with severe respiratory infections receiving immunoglobulin replacement. These findings identify an early window of infectious vulnerability with daratumumab and support temporally targeted prevention and monitoring strategies in contemporary MM care.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.