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Long-Term Benefit of Lenalidomide/Dexamethasone Reported in High-Risk Smoldering Multiple Myeloma

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Key Points

  • Long-term follow-up showed continued benefit of lenalidomide/dexamethasone in preventing disease progression in patients with high-risk smoldering multiple myeloma.
  • There was no significant difference between the groups in survival among patients who received subsequent treatment at disease progression.

As reported by Mateos et al in The Lancet Oncology, long-term follow-up in the phase III QuiRedex trial indicates continued benefit of lenalidomide (Revlimid)/dexamethasone vs observation in preventing disease progression in patients with high-risk smoldering multiple myeloma.

Study Details

In the open-label trial, conducted at 19 sites in Spain and 3 sites in Portugal, 119 patients (constituting the per-protocol population for efficacy analysis) were randomized between November 2007 and June 2010 to receive induction lenalidomide/dexamethasone followed by lenalidomide maintenance and dexamethasone at biologic progression during maintenance (n = 57) or observation (n = 62). At the time of first analysis in 2013, at a median follow-up of 45 months, median time to progression to symptomatic disease was not reached vs 21 months (hazard ratio [HR] = 0.18, P < .0001), and 3-year overall survival was 94% vs 80% (HR = 0.31, P = .03).

Current Analysis

In the current analysis, at median follow-up for surviving patients of 75 months, median time to disease progression was not reached vs 23 months (HR = 0.24, P < .0001), with disease progression occurring in 39% vs 86% of patients. Median overall survival from the time of study entry had not been reached in either group (HR = 0.43, P = .024). There was no significant difference between the groups in survival among patients who received subsequent treatment at disease progression (HR = 1.34, P = .50). Overall, 39% and 85% of patients received antimyeloma treatment after disease progression. Second primary malignancies occurred in 10% of the lenalidomide/dexamethasone group vs 2% of the observation group (P = .070).

The investigators concluded: “This study is, to our knowledge, the first randomised trial in which early treatment has been assessed in selected patients with high-risk smouldering multiple myeloma. Positive results from ongoing trials would support the use of early treatment for patients with high-risk disease in the near future.”

The study was funded by PETHEMA (Spanish Program for the Treatment of Hematologic Diseases).

Maria-Victoria Mateos, PhD, of Instituto de Biologia Molecular y Celular del Cancer, Salamanca, is the corresponding author of The Lancet 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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