Observational studyBMC cancer2026
Quadruplet daratumumab in combination with bortezomib, lenalidomide, and dexamethasone as front-line regimen improved clinical outcomes in high-risk myeloma patients in China: a multi-centered prospective real-world study.
Observational study in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe addition of anti-CD38 monoclonal antibodies daratumumab to bortezomib, lenalidomide, and dexamethasone (D-VRd) has shown deeper responses in clinical trials. However, real-world data on D-VRd in patients with newly diagnosed MM (NDMM) remain limited in China. This study compared the efficacy and safety of D-VRd versus VRd focusing on high-risk subgroups.
methodsThis was a prospective, multicenter, observational study conducted across six Chinese hospitals. We prospectively enrolled NDMM patients receiving first-line D-VRd between August 2020 and August 2024. A historical control cohort of NDMM patients treated with VRd was retrospectively included. High-risk criteria included cytogenetic abnormalities such as del(17p), t(4;14), t(14;16), or 1q21+, while ultra-high-risk (UHiR) defined as ≥ 2 HRCAs. The primary endpoint was progression-free survival (PFS). A multivariable Cox proportional hazards model was fitted, adjusting for key baseline characteristics.
resultsA total of 100 NDMM patients were prospectively enrolled in D-VRd group, the other 221 patients treated with VRd as a control cohort.The median follow-up time was 16.1 months in the D-VRd group and 40.2 months in the VRd group. For the primary endpoint, the 1-year PFS rate was significantly higher in the D-VRd group compared to the VRd group (92.0% vs. 84.5%; HR 0.58, 95% CI 0.36–0.92). Regarding secondary endpoints, the 1-year OS rate also showed improvement (99.0% vs. 97.0%; HR 0.30, 95% CI 0.12–0.72). Among patients with HRCAs, both 1-year PFS (91.5% vs. 80%; HR 0.41, 95% CI 0.23–0.73) and OS (100.0% vs. 92.2%; HR 0.27, 95% CI 0.10–0.77) were significantly improved with D-VRd. In UHiR patients, D-VRd also provided a significant PFS benefit (95.0% vs. 72.0%; HR 0.31, 95% CI 0.14–0.68). In cytogenetic-specific subgroup analyses, patients with 1q21+ (1-year PFS: 91% vs. 81%; HR 0.45, 95% CI 0.24–0.86) or del(17p) (1-year PFS: 86% vs. 63%; HR 0.28, 95% CI 0.11–0.74) derived significant benefit from D-VRd. Among transplant-ineligible patients, 1-year PFS showed a trend favoring D-VRd over VRd (88% vs. 81%; HR 0.56, 95% CI 0.32–0.99). In terms of safety, leukopenia was more frequent in the D-VRd group (22.9% vs. 7.4%), whereas peripheral neuropathy was less common (16.9% vs. 32.5%), with an overall manageable safety profile.
conclusionThis real-world multicenter study in China demonstrates that D-VRd, compared to VRd, provides superior efficacy with a manageable safety profile as frontline therapy for NDMM, particularly in high-risk patients.
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