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<p>Bortezomib-melphalan-prednisone (VMP) is an established induction regimen for transplant-ineligible newly diagnosed multiple myeloma (NDMM), yet optimal post-induction strategies remain unclear. This study evaluated the effectiveness of bortezomib maintenance following VMP using target trial emulation. We compared a prospective maintenance cohort (KMMWP-174 study) with an external control cohort from a multicenter registry. Eligible patients completed 9 VMP cycles, achieved ≥ partial response, and were progression-free for 60 days. The index date was maintenance initiation for cases and day 60 post-VMP for controls. Propensity score matching (1:1) balanced baseline covariates. The primary endpoint was progression-free survival (PFS); overall survival (OS) was secondary. Sensitivity analyses included multivariable regression, landmark analyses, and E-value assessment. Among 178 eligible patients, 60 comprised the maintenance cohort and 118 the control cohort; 54 per group were analyzed after matching. Median PFS was significantly longer with bortezomib maintenance (26.5 vs. 8.8 months; HR 0.437, 95% CI: 0.275–0.694, P &lt; 0.001). PFS benefits were consistent across subgroups, including patients aged ≥ 70 years, those with ISS stage II-III disease, and those with high-risk cytogenetics. OS showed a favorable trend (HR 0.703, P = 0.252). Grade ≥ 3 adverse events occurred in 31.4% (control) and 18.7% (maintenance). No grade ≥ 3 peripheral neuropathy was observed. Bortezomib maintenance following VMP significantly prolonged PFS in transplant-ineligible NDMM with acceptable toxicity. These real-world data support proteasome inhibitor-based maintenance where VMP remains widely used, particularly among older adults with limited treatment options.</p>

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Real-world effectiveness of bortezomib maintenance following VMP induction in transplant-ineligible multiple myeloma: a target trial emulation study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月23日

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  • Jung Yeon Lee,
  • Suein Choi,
  • Seungpil Jung,
  • Sung-Soo Park,
  • Jin Seok Kim,
  • Seung-Hwan Shin,
  • Young-Woo Jeon,
  • Seung-Ah Yahng,
  • Je-Jung Lee,
  • Hyo Jung Kim,
  • Gyeong-Won Lee,
  • Hyeon-Seok Eom,
  • Min Kyoung Kim,
  • Yundeok Kim,
  • Jihyun Kwon,
  • Chang-Ki Min

摘要

Bortezomib-melphalan-prednisone (VMP) is an established induction regimen for transplant-ineligible newly diagnosed multiple myeloma (NDMM), yet optimal post-induction strategies remain unclear. This study evaluated the effectiveness of bortezomib maintenance following VMP using target trial emulation. We compared a prospective maintenance cohort (KMMWP-174 study) with an external control cohort from a multicenter registry. Eligible patients completed 9 VMP cycles, achieved ≥ partial response, and were progression-free for 60 days. The index date was maintenance initiation for cases and day 60 post-VMP for controls. Propensity score matching (1:1) balanced baseline covariates. The primary endpoint was progression-free survival (PFS); overall survival (OS) was secondary. Sensitivity analyses included multivariable regression, landmark analyses, and E-value assessment. Among 178 eligible patients, 60 comprised the maintenance cohort and 118 the control cohort; 54 per group were analyzed after matching. Median PFS was significantly longer with bortezomib maintenance (26.5 vs. 8.8 months; HR 0.437, 95% CI: 0.275–0.694, P < 0.001). PFS benefits were consistent across subgroups, including patients aged ≥ 70 years, those with ISS stage II-III disease, and those with high-risk cytogenetics. OS showed a favorable trend (HR 0.703, P = 0.252). Grade ≥ 3 adverse events occurred in 31.4% (control) and 18.7% (maintenance). No grade ≥ 3 peripheral neuropathy was observed. Bortezomib maintenance following VMP significantly prolonged PFS in transplant-ineligible NDMM with acceptable toxicity. These real-world data support proteasome inhibitor-based maintenance where VMP remains widely used, particularly among older adults with limited treatment options.