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December 8, 2025Blood

Isatuximab subcutaneous in relapsed/refractory multiple myeloma: Exposure-response and serum m-protein dynamics analyses from phase 3 iraklia Study and the phase 1b Study

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Authors

NGNadia GaudelHTHoai‐Thu Thai

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Overview

Phase 3 trial shows subcutaneous isatuximab improves treatment response in multiple myeloma, suggesting effective dosing strategies.

Key Points

  • Evaluate isatuximab subcutaneous treatment efficacy and safety in relapsed/refractory multiple myeloma.
  • Analyses from Phase 3 IRAKLIA and Phase 1b studies.
  • Evaluated overall response rate and serum M-protein dynamics.
  • Used a population pharmacokinetic model to predict exposure metrics.
  • Subcutaneous isatuximab demonstrated comparable overall response rates to intravenous treatment.
  • Higher treatment responses were associated with higher exposure metrics and specific patient characteristics.
  • No significant correlation was found between isatuximab exposure and adverse events.

Cite This Study

Gaudel et al. (2025) studied this question.

synapsesocial.com/papers/693624d74fa91c937236d17bhttps://doi.org/10.1182/blood-2025-5826
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Isatuximab (Isa) subcutaneous (SC) via an on-body injector (OBI) vs isa intravenous (IV), plus pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma (RRMM): East asia subgroup results from the randomized, non-inferiority, phase 3 iraklia study2025
  2. 2Isatuximab subcutaneous by on-body injector in Relapsed/Refractory multiple myeloma in the Phase 3 iraklia study: Effect of body weight on pharmacokinetics and clinical outcome2025
  3. 3Updated results from the phase 2 IZALCO study: Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma.2026
  4. 4Safety and reliability of isatuximab subcutaneous on-body injector: Results across the phase 3 IRAKLIA, phase 2 IZALCO and phase 1b TCD15484 trials.2026
  5. 5Multicenter phase 2 study of subcutaneous isatuximab plus bortezomib , lenalidomide and dexamethasone (Isa Sc-VRd) in transplant ineligible newly diagnosed multiple myeloma: Final analysis of the isasocut study (IFM 2022-05)2025 · 1 citations