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December 8, 2025BloodOpen Access

Final results of a multi-center phase 2 trial of isatuximab-lenalidomide in patients with high risk smoldering multiple myeloma (HRSMM)

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Authors

NKNeha KordeHLHans C. LeeKPKrina K. Patel

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Overview

Phase II trial shows high response rates and favorable progression-free survival in high-risk smoldering multiple myeloma patients receiving isatuximab-lenalidomide therapy.

Key Points

  • To evaluate the efficacy and safety of isatuximab-lenalidomide in patients with high-risk smoldering multiple myeloma.
  • Conducted a multi-center phase II trial with patients treated on 28-day cycles.
  • Isatuximab was administered intravenously, combined with lenalidomide taken orally.
  • Primary endpoint was overall response rate after 6 cycles; secondary endpoints included progression-free survival and overall survival.
  • Overall response rate improved to 97% by the end of 30 cycles.
  • 4-year progression-free survival reached 94.3%.
  • Common treatment-related adverse events included lymphopenia, anemia, neutropenia, and leukocytopenia.

Cite This Study

Korde et al. (2025) studied this question.

synapsesocial.com/papers/693624d74fa91c937236d154https://doi.org/10.1182/blood-2025-5834
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  2. 2Isatuximab with bortezomib, cyclophosphamide, and dexamethasone followed by isatuximab and lenalidomide maintenance in newly diagnosed multiple myeloma patients with severe renal impairment: Final analysis of a phase 2 study by the greek myeloma study group2025
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