Effect of daratumumab on patients with high-risk cytogenetic multiple myeloma: a systematic review and meta-analysis of randomized controlled trials
In brief
Daratumumab cuts progression risk by about 40% in high-risk myeloma
Adding daratumumab to standard regimens reduced the chance of disease progression by roughly 40% in patients with cytogenetically high-risk multiple myeloma, with benefits seen in both newly diagnosed and relapsed settings. Overall survival also improved modestly, but the result was not consistent across analyses, so larger trials are needed to confirm a true survival advantage.
- Journal
- Frontiers in immunology (Q1)
- Published
- 27 August 2026
- Study design
- Systematic review / meta-analysis of RCTs
- Evidence level
- Level 1, High (CEBM 1a)
- Authors
- Liang Su, Minlan Ye, Bowen Peng, Lei Fan, Jie Wu
- PMID
- 42724012
- DOI
- 10.3389/fimmu.2026.1787690
Why clinicians should know about it
- Picked for Hematology (top studies of the week, 13 September 2026): Daratumumab improves outcomes in high‑risk cytogenetic multiple myeloma
- Picked for Oncology and Radiation Oncology (top studies of the week, 13 September 2026): Daratumumab improves PFS, OS in high‑risk cytogenetic MM
Abstract
UNLABELLED: Although daratumumab has been reported to significantly improve the prognosis of multiple myeloma (MM), its efficacy in patients with cytogenetically high-risk MM (HRMM) remains unclear. This meta-analysis aims to evaluate the effect of daratumumab on progression-free survival (PFS) and overall survival (OS) in patients with cytogenetically HRMM. Compared to treatment without daratumumab, treatment with daratumumab showed significant PFS (HR = 0.58, P < 0.001) and OS (HR = 0.74, P = 0.017) benefit in patients with cytogenetically HRMM. Subgroup analyses revealed similar PFS benefits for newly diagnosed MM (HR = 0.63, P < 0.001), relapsed or refractory MM (HR = 0.53, P < 0.001), subcutaneous daratumumab (HR = 0.69, P = 0.038), and intravenous daratumumab (HR = 0.53, P < 0.001). Meanwhile, daratumumab significantly improved PFS in patients with revised high cytogenetic risk (HR = 0.51, P < 0.001). Another subgroup analysis revealed that daratumumab significantly improved PFS in both the one high-risk cytogenetic abnormality (HRCA) group (HR = 0.46, P < 0.001) and the isolated gain/amp(1q21) group (HR = 0.49, P < 0.001), while no significant improvement in PFS was observed in the group with more than or equal to two HRCAs (HR = 0.64, P = 0.212). However, sensitivity analysis showed that the beneficial OS is not robust. These results suggested that incorporating daratumumab into treatment regimens for patients with cytogenetic HRMM resulted in improved PFS. However, the effect of daratumumab on PFS may depend on HRCAs status. Additionally, the OS findings were suggestive of a potential benefit but require validation in future trials. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420251244272.
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.