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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 (ClinicalTrials.gov 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 ash.confex.com.


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