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December 8, 2025BloodOpen Access

Isatuximab (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 study

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Authors

ZXZhongjun XiaJLJing LiuCSChunyan Sun

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Overview

Randomized trial shows comparable overall response rates in subcutaneous and intravenous isatuximab for RRMM, indicating higher patient satisfaction with SC delivery.

Key Points

  • To evaluate non-inferiority of subcutaneous isatuximab versus intravenous in patients with relapsed/refractory multiple myeloma in East Asia.
  • Randomized, open-label trial with a 1:1 allocation to SC or IV isatuximab with pomalidomide and dexamethasone.
  • Included patients with prior therapy exposure and utilized 4-week treatment cycles.
  • Endpoints included overall response rate, Ctrough levels, infusion reaction rate, and patient satisfaction.
  • Overall response rate was 74.0% for SC and 70.9% for IV, indicating non-inferiority.
  • Ctrough was significantly higher in SC (502 µg/mL) compared to IV (282 µg/mL).
  • Infusion reactions were absent in the SC group, while 21.8% experienced them in the IV group.

Cite This Study

Xia et al. (2025) studied this question.

synapsesocial.com/papers/693624d74fa91c937236d16chttps://doi.org/10.1182/blood-2025-5819
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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. 2Multicenter 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
  3. 3Isatuximab 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
  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. 5Isatuximab (Isa) plus lenalidomide (R), Bortezomib (V), and dexamethasone (d) (Isa-RVd) as induction therapy in transplant-eligible patients (pts) with newly diagnosed multiple myeloma (NDMM): Primary analysis of parallel phase 2 studies by the Dana-Farber Cancer Institute (DFCI) and Cancer Trials Ireland (CTI)2025