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December 8, 2025Blood

Updated results from the frailty-stratified, randomised controlled bayesian adaptive trial of bortezomib versus lenalidomide in transplant ineligible myeloma (TI NDMM) – the FRAIL-m study (AMaRC 19-01; ALLG MM22)

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Authors

TWTricia WrightSLSophie LeePMPeter Mollee

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Overview

Randomised trial shows safety and efficacy in frail individuals with myeloma using updated regimens, suggesting need for tailored treatment strategies.

Key Points

  • To assess the efficacy and safety of bortezomib and lenalidomide regimens in frail transplant ineligible myeloma patients.
  • Frailty-stratified, adaptive Phase Ib/II trial involving randomisation to treatment regimens.
  • Use of frailty assessments including the Charlson Comorbidity Index to stratify patients.
  • Efficacy and safety evaluated through objective response rate and deliverability-limiting toxicity.
  • In frail patients, treatment response rates reached 96%, with deliverability-limiting toxicity at approximately 36%.
  • Regular monitoring using credible intervals for response rates and toxicity levels sustained throughout the trial.
  • Preliminary findings indicate promising efficacy while highlighting the need for adapted therapy based on frailty levels.

Cite This Study

Wright et al. (2025) studied this question.

synapsesocial.com/papers/693624d74fa91c937236d158https://doi.org/10.1182/blood-2025-5842
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Also Consider

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

  1. 1Is IMWG frailty-score-adjusted dosing the right approach to improve toxicity and outcomes in FRAIL patients? Results from the UK-MRA FiTNEss trial in newly diagnosed myeloma patients ineligible for ASCT.2025
  2. 2Daratumumab plus bortezomib, lenalidomide, and dexamethasone in transplant-deferred newly diagnosed multiple myeloma: Frailty subgroup analysis of CEPHEUS2026
  3. 3First-line treatment in patients with transplant-ineligible, newly diagnosed multiple myeloma by age, frailty, and comorbidity2025
  4. 4Phase 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
  5. 5Age and frailty analyses of transplant-ineligible (TIE) patients (pts) with newly diagnosed multiple myeloma (NDMM) in the phase 3 MAIA and CEPHEUS trials of daratumumab + lenalidomide-dexamethasone (Rd) and bortezomib-Rd (VRd).2026