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Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation

Fecha de publicación: Fecha Ahead of Print:

Autores de IDIVAL

Autores ajenos al IDIVAL

  • Perrot A
  • Bories P
  • San-Miguel JF
  • Blau IW
  • Karlin L
  • Martinez-Lopez J
  • Wang SY
  • Bringhen S
  • Marcatti M
  • Mateos MV
  • Rodriguez-Otero P
  • Oliva S
  • Nogai A
  • Le Roux N
  • Dong L
  • Macé S
  • Gassiot M
  • Fitzmaurice T
  • Oprea C
  • Moreau P

Unidades

Abstract

Patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplantation (ASCT) have lower survival rates and may benefit from frontline regimens that include novel agents. This Phase 1b study (NCT02513186) evaluated preliminary efficacy, safety, and pharmacokinetics (PK) of isatuximab, an anti-CD38 monoclonal antibody, combined with bortezomib-lenalidomide-dexamethasone (Isa-VRd) in patients with NDMM ineligible for/with no intent for immediate ASCT. Overall, 73 patients received four 6-week induction cycles of Isa-VRd, then maintenance with Isa-Rd in 4-week cycles. In the efficacy population (n = 71), the overall response rate was 98.6%, with 56.3% achieving a complete response or better (sCR/CR), and 36/71 (50.7%) patients reaching minimal residual disease negativity (10(-5) sensitivity). Grade >= 3 treatment-emergent adverse events (TEAEs) occurred in 79.5% (58/73) of patients but TEAEs leading to permanent study treatment discontinuation were reported in 14 (19.2%) patients. Isatuximab PK parameters were within the previously reported range, suggesting that VRd does not alter the PK of isatuximab. These data support additional studies of isatuximab in NDMM, such as the Phase 3 IMROZ study (Isa-VRd vs VRd).

© 2023. The Author(s).

Datos de la publicación

ISSN/ISSNe:
0887-6924, 1476-5551

LEUKEMIA  NATURE PUBLISHING GROUP

Tipo:
Article
Páginas:
1521-1529
PubMed:
37316728

Citas Recibidas en Web of Science: 14

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