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December 8, 2025BloodOpen Access

Multicenter 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)

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Authors

RZRick ZhangTBThorsten BraunRTReza Tabrizi

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Overview

Phase 2 trial showed high efficacy with ≥87.8% response rate in transplant ineligible multiple myeloma, indicating safety and improved convenience.

Key Points

  • To evaluate the efficacy and safety of subcutaneous isatuximab combined with bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma patients who are transplant ineligible.
  • Prospective, multicenter, open-label, phase 2 study in NDMM TI patients aged ≥65 years.
  • Patients received isatuximab subcutaneously, along with bortezomib, lenalidomide, and dexamethasone over 12 cycles and followed by a maintenance phase.
  • Primary endpoint was the ≥very good partial response (VGPR) rate at 8 months.
  • The ≥VGPR rate was 87.8% (n=65) with a median follow-up of 11.7 months.
  • MRD negativity rates were 35.1% at 10⁻⁵ and 27% at 10⁻⁶.
  • No new safety signals observed; adverse events included infusion reactions in 9.5% of patients and neurological events in 47.3%.

Cite This Study

Zhang et al. (2025) studied this question.

synapsesocial.com/papers/69362f694fa91c937236df4chttps://doi.org/10.1182/blood-2025-2275
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Also Consider

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

  1. 1Phase 3 randomized study of isatuximab (Isa) plus lenalidomide and dexamethasone (Rd) with bortezomib versus isard in patients with newly diagnosed transplant ineligible multiple myeloma (NDMM TI).2024 · 3 citations
  2. 2Comparative analysis of subcutaneous Isa VRd (ISASOCUT) and intravenous Isa VRd (IMROZ) in transplant-ineligible newly diagnosed multiple myeloma across age groups.2026
  3. 3P13 | ISATUXIMAB 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 GREEK MYELOMA STUDY GROUP2026
  4. 4Phase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ).2024 · 6 citations
  5. 5Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial2024 · 116 citations