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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 controlled trial demonstrates improved efficacy in frail myeloma patients, suggesting treatment adaptations may improve safety and outcomes.

Key Points

  • To evaluate the efficacy and safety of bortezomib and lenalidomide in transplant ineligible myeloma patients stratified by frailty.
  • Frailty-stratified, adaptive Phase Ib/II trial assigned patients to treatment groups based on frailty.
  • Patients received either bortezomib-based or lenalidomide-based regimens after assessment using frailty scores.
  • Primary outcomes included overall response rate and safety monitoring for treatment-related toxicity.
  • Efficacy in frail patients showed an overall response rate of 96% with bortezomib, 66% with lenalidomide.
  • Toxicity rates in frail patients indicated a need for dose modifications, particularly in the triplet regimen.
  • Both treatment arms demonstrated acceptable efficacy, though toxicity concerns emerged that may necessitate further interventions.

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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