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Background <p>Daratumumab (Dara), a humanized IgGκ monoclonal antibody targeting CD38, has shown significant efficacy in the treatment of multiple myeloma (MM). However, its impact on myeloma bone disease (MBD) and skeletal-related events (SREs) remains inadequately explored. Elucidating the effect of Dara on the incidence of SREs is of considerable clinical importance for MM management.</p> Methods <p>We conducted a multicenter retrospective analysis of 164 newly diagnosed MM (NDMM) patients who received first-line treatment with or without Dara-based regimens between December 2019 and December 2023. The primary endpoint was the incidence of first SRE within 6 months. Subgroup analyses were performed based on risk stratification, baseline hypercalcemia, extramedullary disease, circulating plasma cells, and use of anti-bone resorption drugs. Statistical analyses included Kaplan-Meier survival curves, log-rank tests, and Cox proportional hazards models with adjustment for covariates.</p> Results <p>The overall incidence of SREs was 17.68% (29/164), with 9.80% (5/51) in the Dara group and 21.23% (24/113) in the control group (log-rank <i>P</i> = 0.08). Univariable and multivariable Cox regression analyses consistently showed a non-significant reduction in SRE risk with Dara-based treatment (HR = 0.44, 95% CI: 0.17–1.15, <i>P</i> = 0.09; adjusted HR = 0.47, 95% CI: 0.17–1.28, <i>P</i> = 0.14). Subgroup analyses revealed a significant benefit of Dara in patients without baseline hypercalcemia (HR = 0.19, 95% CI: 0.05–0.81, <i>P</i> = 0.02) and a suggestive benefit in the standard-risk subgroup (log-rank <i>P</i> &lt; 0.05). A significant interaction was observed between Dara use and hypercalcemia status (P for interaction = 0.03).</p> Conclusions <p>While Dara-based treatment did not significantly reduce SRE incidence in the overall cohort, it may provide protective benefits against SREs in specific subgroups, particularly among patients without hypercalcemia. Our finding warrants further investigation into the bone-protective effects of Dara in MM.</p>

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The effects of daratumumab on bone disease in patients with newly diagnosed multiple myeloma: a multi-center retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月22日

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  • Xinrong Li,
  • Hua Wang,
  • Yizhen Li,
  • Jing Zhou,
  • Nianhui Yang,
  • Xiaolei Wei,
  • Xiangran Cai,
  • Zeyu Xiao,
  • Juan Du,
  • Hui Zeng

摘要

Background

Daratumumab (Dara), a humanized IgGκ monoclonal antibody targeting CD38, has shown significant efficacy in the treatment of multiple myeloma (MM). However, its impact on myeloma bone disease (MBD) and skeletal-related events (SREs) remains inadequately explored. Elucidating the effect of Dara on the incidence of SREs is of considerable clinical importance for MM management.

Methods

We conducted a multicenter retrospective analysis of 164 newly diagnosed MM (NDMM) patients who received first-line treatment with or without Dara-based regimens between December 2019 and December 2023. The primary endpoint was the incidence of first SRE within 6 months. Subgroup analyses were performed based on risk stratification, baseline hypercalcemia, extramedullary disease, circulating plasma cells, and use of anti-bone resorption drugs. Statistical analyses included Kaplan-Meier survival curves, log-rank tests, and Cox proportional hazards models with adjustment for covariates.

Results

The overall incidence of SREs was 17.68% (29/164), with 9.80% (5/51) in the Dara group and 21.23% (24/113) in the control group (log-rank P = 0.08). Univariable and multivariable Cox regression analyses consistently showed a non-significant reduction in SRE risk with Dara-based treatment (HR = 0.44, 95% CI: 0.17–1.15, P = 0.09; adjusted HR = 0.47, 95% CI: 0.17–1.28, P = 0.14). Subgroup analyses revealed a significant benefit of Dara in patients without baseline hypercalcemia (HR = 0.19, 95% CI: 0.05–0.81, P = 0.02) and a suggestive benefit in the standard-risk subgroup (log-rank P < 0.05). A significant interaction was observed between Dara use and hypercalcemia status (P for interaction = 0.03).

Conclusions

While Dara-based treatment did not significantly reduce SRE incidence in the overall cohort, it may provide protective benefits against SREs in specific subgroups, particularly among patients without hypercalcemia. Our finding warrants further investigation into the bone-protective effects of Dara in MM.