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Isatuximab plus bortezomib, lenalidomide, and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma patients: a frailty subgroup analysis of the IMROZ trial

Patients with multiple myeloma (MM) meeting frailty criteria have worse outcomes than those identified as non-frail. Here, we present a post hoc subgroup analysis of IMROZ, a global, phase III, open-label study investigating isatuximab (Isa) with bortezomib, lenalidomide, and dexamethasone (VRd) fol...

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Main Authors: Manier, Salomon (Author) , Dimopoulos, Meletios-Athanasios (Author) , Leleu, Xavier P. (Author) , Moreau, Philippe (Author) , Cavo, Michele (Author) , Goldschmidt, Hartmut (Author) , Orlowski, Robert Z. (Author) , Tron, Muriel (Author) , Tekle, Christina (Author) , Brégeault, Marie-France (Author) , Shafer, Andrea T. (Author) , Beksac, Meral (Author) , Facon, Thierry (Author)
Format: Article (Journal)
Language:English
Published: September, 2025
In: Haematologica
Year: 2025, Volume: 110, Issue: 9, Pages: 2139-2150
ISSN:1592-8721
DOI:10.3324/haematol.2024.287200
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.3324/haematol.2024.287200
Verlag, lizenzpflichtig, Volltext: https://haematologica.org/article/view/11994
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Author Notes:Salomon Manier, Meletios-Athanasios Dimopoulos, Xavier P. Leleu, Philippe Moreau, Michele Cavo, Hartmut Goldschmidt, Robert Z. Orlowski, Muriel Tron, Christina Tekle, Marie-France Brégeault, Andrea T. Shafer, Meral Beksac and Thierry Facon
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Summary:Patients with multiple myeloma (MM) meeting frailty criteria have worse outcomes than those identified as non-frail. Here, we present a post hoc subgroup analysis of IMROZ, a global, phase III, open-label study investigating isatuximab (Isa) with bortezomib, lenalidomide, and dexamethasone (VRd) followed by Isa-Rd (N=265) versus VRd followed by Rd (N=181) in newly diagnosed transplant-ineligible MM (Ti NDMM) patients using the simplified International Myeloma Working Group (sIMWG) frailty score. Although patients aged >80 years were excluded, there was no exclusion for patients meeting frailty criteria. All patients received standard VRd/Rd dosing; Isa-VRd patients received intravenous Isa (cycle 1, 10 mg/kg once weekly; cycles 2-17, once every 2 weeks; subsequent cycles, once every 4 weeks). Patients with a frailty score of 0/1 were considered nonfrail; scores ≥2 were frail. Using this scoring, 26.7% of patients were frail (26.0% Isa-VRd; 27.6% VRd), and 72.0% non-frail (72.8% Isa-VRd; 70.7% VRd). After a median follow-up of 59.7 months, Isa-VRd significantly improved progression-free survival versus VRd in frail patients (hazard ratio [HR] =0.518; 95% confidence interval [CI]: 0.294-0.912; P=0.0227) and non-frail patients (HR=0.615; 95% CI: 0.419-0.903; P=0.0131). Significantly more frail patients receiving Isa-VRd than VRd achieved minimal residual disease negativity and complete response (odds ratio=3.459; 95% CI: 1.495-8.006; P=0.0030 at 10-5 by next-generation sequencing). Rates of treatment-emergent adverse events leading to definitive discontinuation were similar between both arms regardless of frailty status. This post hoc subgroup analysis of the IMROZ trial demonstrated that Isa-VRd is an effective option with a manageable safety profile for frail patients with Ti NDMM (clinicaltrials gov. Identifier: NCT03319667).
Item Description:Gesehen am 03.02.2026
Physical Description:Online Resource
ISSN:1592-8721
DOI:10.3324/haematol.2024.287200

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