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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 found isatuximab-lenalidomide achieves 94% progression-free survival in high risk smoldering multiple myeloma.

Key Points

  • To evaluate the efficacy and safety of isatuximab-lenalidomide in patients with high risk smoldering multiple myeloma.
  • Multi-center phase II trial with patients receiving isatuximab and lenalidomide
  • Treatment involved 28-day cycles with specified dosing schedules for both drugs
  • Primary endpoint was overall response rate after 6 cycles
  • Secondary endpoints included progression-free survival and overall survival
  • Overall response rate was 86% after 6 cycles, increasing to 94% after 18 cycles
  • 94% of patients maintained progression-free survival at 4 years
  • No patients died during the trial, highlighting safety and efficacy of the regimen

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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Also Consider

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

  1. 1Isatuximab 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
  2. 2An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma (MM) incorporating iberdomide, isatuximab, and dexamethasone – the IBIS study amarc 20-01.2025 · 1 citations
  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. 4Low conversion rates to minimal residual disease (MRD) negativity despite improved IMWG responses with lenalidomide-isatuximab maintenance after autologous stem cell transplant (ASCT) in multiple myeloma.2025
  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