Lenalidomide Maintenance After Autologous Stem Cell Transplantation in Multiple Myeloma


Key Points

  • In patients with newly diagnosed multiple myeloma, overall survival was significantly prolonged with lenalidomide maintenance.
  • Myeloma-specific survival was significantly prolonged in the lenalidomide group.

According to a meta-analysis reported in the Journal of Clinical Oncology by McCarthy et al, lenalidomide (Revlimid) maintenance therapy after autologous stem cell transplantation (ASCT) was associated with improved progression-free and overall survival vs placebo or observation in patients with newly diagnosed multiple myeloma.

Study Details

The meta-analysis included patient-level data from 1,208 patients from 3 trials (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell’Adulto RV-MM-PI-209, and Intergroupe Francophone du Myélome 2005-02) that randomized patients to receive lenalidomide maintenance (n = 605) or placebo or observation (n = 603). All studies had shown a progression-free survival benefit with lenalidomide but were not powered for analysis of overall survival.

Survival Outcomes

Median progression-free survival was 52.8 months in the lenalidomide group vs 23.5 months in the placebo/observation group (hazard ratio [HR] = 0.48, 95% confidence interval [CI] = 0.41–0.55). Median progression-free survival was 73.3 months vs 56.7 months (HR = 0.72, 95% CI = 0.62–0.84). At a median follow-up of 79.5 months in all surviving patients, median overall survival was not reached in the lenalidomide group vs 86.0 months in the placebo/observation group (HR = 0.75, P = .001). Time to death as a result of myeloma was significantly prolonged in the lenalidomide group (HR = 0.66, P < .001).

The cumulative incidence rate of a second primary malignancy before disease progression was higher in the lenalidomide group (5.3% vs 0.8% for hematologic and 5.8% vs 2.0% for solid malignancies).

The investigators concluded: “This meta-analysis demonstrates a significant [overall survival] benefit and confirms the [progression-free survival] benefit with lenalidomide maintenance after ASCT in patients with [newly diagnosed multiple myeloma] when compared with placebo or observation.”

The study was supported by Celgene Corporation.

Philip L. McCarthy, MD, of Roswell Park Cancer Institute, is the corresponding author of the Journal of Clinical Oncology article. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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