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JOURNAL ARTICLE

Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma

Sagar Lonial, Susanna Jacobus, Rafael Fonseca, Matthias Weiss, Shaji Kumar, Robert Z Orlowski, Jonathan L Kaufman, Abdulraheem M Yacoub, Francis K Buadi, Timothy O'Brien, Jeffrey V Matous, Daniel M Anderson, Robert V Emmons, Anuj Mahindra, Lynne I Wagner, Madhav V Dhodapkar, S Vincent Rajkumar
Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 2019 October 25, : JCO1901740
31652094

PURPOSE: Observation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma.

METHODS: We conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression.

RESULTS: One hundred eighty-two patients were randomly assigned-92 patients to the lenalidomide arm and 90 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62; P = .002). One-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI, 0.08 to 2.53). Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalidomide.

CONCLUSION: Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.

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