Efficacy of isatuximab in combination with steroids for the treatment of relapsed/refractory multiple myeloma patients exhibiting only biochemical progression-A single center retrospective study

Eur J Haematol. 2023 Oct;111(4):628-635. doi: 10.1111/ejh.14057. Epub 2023 Jul 24.

Abstract

Objectives: Isatuximab is approved for treatment of relapsed/refractory multiple myeloma (RRMM) with dexamethasone and carfilzomib or pomalidomide. Patients receiving these three-drug regimens have exhibited more Grade ≥ 3 adverse events (AEs) compared to the two-drug class combination of isatuximab and steroids alone. Thus, this single-center retrospective study investigated the efficacy of isatuximab with dexamethasone and methylprednisolone (ISAdm) for RRMM patients showing only biochemical progression (BP) of their disease.

Methods: Twenty-four RRMM patients exhibiting only BP were administered isatuximab at 10 mg/kg with dexamethasone once weekly for cycle 1 of a 28-day cycle, followed by every other week for each cycle thereafter. Starting in cycle 2, oral methylprednisolone was added every other day stopping 48 h before and starting 48 h after each dexamethasone infusion.

Results: Overall response rate and clinical benefit rate were 63% and 79%, respectively. Progression free survival was 12.9 months. There were only 5 AEs of Grade ≥ 3 which included lymphocytopenia (13%), leukopenia (4%), and neutropenia (4%). No Grade ≥ 3 AE related to respiratory infection, anemia, or thrombocytopenia were reported.

Conclusion: This study shows that the two-drug class combination of ISAdm is an effective and well tolerated treatment option for RRMM patients exhibiting only BP.

Keywords: anti-CD38; isatuximab; multiple myeloma; relapsed/refractory.

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Dexamethasone
  • Humans
  • Multiple Myeloma* / diagnosis
  • Multiple Myeloma* / drug therapy
  • Multiple Myeloma* / etiology
  • Neoplasm Recurrence, Local / drug therapy
  • Retrospective Studies
  • Steroids / therapeutic use

Substances

  • isatuximab
  • Dexamethasone
  • Steroids