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December 8, 2025Blood

Isatuximab subcutaneous by on-body injector in Relapsed/Refractory multiple myeloma in the Phase 3 iraklia study: Effect of body weight on pharmacokinetics and clinical outcome

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Authors

ABAlejandro BerkovitsASAndrew SpencerFLFei Li

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Overview

Phase 3 trial finds comparable efficacy and safety for isatuximab in different body weight groups, indicating a flat-dose approach is viable.

Key Points

  • Efficacy of isatuximab is maintained across various body weight groups, showing comparable response rates and safety profiles.
  • The analysis demonstrated treatment discontinuation rates between isatuximab and pomalidomide-dexamethasone vary by body weight, affecting overall patient management.
  • Neutropenia incidence was similar across body weight ranges, reinforcing the safety of isatuximab subcutaneous administration in diverse populations.
  • Pharmacokinetics of isatuximab suggest no need for dose adjustment based on body weight, supporting its flat dosing strategy.

Cite This Study

Berkovits et al. (2025) studied this question.

synapsesocial.com/papers/69362f634fa91c937236de29https://doi.org/10.1182/blood-2025-5812
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Also Consider

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

  1. 1Isatuximab subcutaneous in relapsed/refractory multiple myeloma: Exposure-response and serum m-protein dynamics analyses from phase 3 iraklia Study and the phase 1b Study2025 · 1 citations
  2. 2Isatuximab (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
  3. 3Multicenter 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
  4. 4Isatuximab 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
  5. 5Efficacy and safety of isa-vrd in elderly patients with or without frailty criteria: Pooled analysis of imroz and phase 1b studies in newly diagnosed multiple myeloma patients2025 · 1 citations