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What Is the Optimal Duration of Lenalidomide Maintenance Therapy After ASCT?

By: Vanessa A. Carter, BS
Posted: Tuesday, January 17, 2023

Charlotte Pawlyn, PhD, of the Royal Marsden Hospital NHS Foundation Trust, London, and colleagues analyzed data from the Myeloma XI trial ( identifier NCT01554852) to determine whether optimal treatment duration differed in patients with standard versus high-risk genetics. Presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 570), the results of this trial suggest that continuing maintenance with lenalidomide beyond 3 years correlates with improved progression-free survival.

“There does, however, appear to be a time after autologous stem cell transplant [ASCT] at which continuing maintenance may no longer have ongoing benefit over observation,” stated the investigators. “The current analysis suggests that between 4 and 5 years the impact diminished in all patients, earlier in the subgroup of patients with [measurable] residual disease (MRD) negativity after ASCT.”

This phase III trial enrolled 1,248 patients with newly diagnosed multiple myeloma who were allocated to undergo lenalidomide maintenance (n = 730) or observation (n = 518) after treatment with combination therapy of thalidomide, lenalidomide, carfilzomib, bortezomib, and vorinostat. Participant data were analyzed based on genetic risk subgroup and MRD status.

At the median follow-up of 44.7 months, maintenance therapy with lenalidomide was associated with a significant progression-free survival benefit compared with observation alone in any risk group (P < .0001). Of note, the magnitude of this benefit continued 2 (P < .001), 3 (P < .0001), and 4 (P = .031) years after randomization but diminished thereafter. Furthermore, patients with MRD at maintenance induction experienced a benefit with a longer duration of lenalidomide maintenance than those with MRD negativity.

Regardless of risk status, there was an ongoing benefit of maintenance therapy even after 2 to 3 years. Of note, participants on long-term lenalidomide maintenance did not experience worsening bone marrow suppression. Neutropenia was reported in 57% of patients, although this number gradually reduced with the continuation of maintenance therapy.

Disclosure: For full disclosures of the study authors, visit

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