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Background <p>To evaluate the real-world effectiveness, overall survival (OS), durability of response, and tolerability of daratumumab-based therapy for systemic amyloid light-chain (AL) amyloidosis in Japan, where bortezomib and daratumumab were only recently introduced, using 3-year follow-up data.</p> Methods <p>We retrospectively reviewed 43 patients diagnosed with AL amyloidosis. Fifteen patients received daratumumab-containing regimens (Dara group) and 28 received non-daratumumab therapy (non-Dara group). Clinical characteristics, hematologic response (HR), organ response (OR), OS, and treatment tolerability were compared. Four patients with Mayo 2012 stage IV disease underwent stepwise dose modification of daratumumab-based therapy.</p> Results <p>The Dara group showed significantly higher HR (93% vs. 35.7%) and OR (71.4% vs. 19.2%) and improved OS compared with the non-Dara group. At a median follow-up of 34&#xa0;months, 11 of the 12 surviving patients in the Dara group maintained a complete HR. In Mayo stage IV cases, reduced-intensity induction with daratumumab and dexamethasone, followed by gradual intensification, achieved an OR in most patients evaluated.</p> Conclusions <p>Daratumumab-based therapy resulted in high response rates, durable remission, and improved OS in patients with systemic AL amyloidosis. Daratumumab-based strategies may benefit patients across risk groups, including those with advanced cardiac involvement.</p>

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Daratumumab-based therapy in systemic AL amyloidosis including advanced cardiac involvement: a single center study

  • 期刊论文

  • 发表日期：

    2026年5月18日

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  • Yuri Miyazawa,
  • Shuhei Kanaya,
  • Hisashi Takei,
  • Nobuhiko Kobayashi,
  • Yohei Osaki,
  • Yoshiyuki Ogawa,
  • Akihiko Yokohama,
  • Takayuki Saitoh,
  • Hiroshi Handa

摘要

Background

To evaluate the real-world effectiveness, overall survival (OS), durability of response, and tolerability of daratumumab-based therapy for systemic amyloid light-chain (AL) amyloidosis in Japan, where bortezomib and daratumumab were only recently introduced, using 3-year follow-up data.

Methods

We retrospectively reviewed 43 patients diagnosed with AL amyloidosis. Fifteen patients received daratumumab-containing regimens (Dara group) and 28 received non-daratumumab therapy (non-Dara group). Clinical characteristics, hematologic response (HR), organ response (OR), OS, and treatment tolerability were compared. Four patients with Mayo 2012 stage IV disease underwent stepwise dose modification of daratumumab-based therapy.

Results

The Dara group showed significantly higher HR (93% vs. 35.7%) and OR (71.4% vs. 19.2%) and improved OS compared with the non-Dara group. At a median follow-up of 34 months, 11 of the 12 surviving patients in the Dara group maintained a complete HR. In Mayo stage IV cases, reduced-intensity induction with daratumumab and dexamethasone, followed by gradual intensification, achieved an OR in most patients evaluated.

Conclusions

Daratumumab-based therapy resulted in high response rates, durable remission, and improved OS in patients with systemic AL amyloidosis. Daratumumab-based strategies may benefit patients across risk groups, including those with advanced cardiac involvement.