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Randomized trial of lenalidomide vs observation in smoldering multiple myeloma

Journal of Clinical Oncology Nov 05, 2019

Lonial S, Jacobus S, Fonseca R, et al. - Experts carried out a randomized trial that evaluated the efficiency of single-agent lenalidomide in comparison with observation in individuals with intermediate- or high-risk smoldering multiple myeloma. One hundred eighty-two individuals were randomized to the lenalidomide arm (n = 92) and to the observation arm (n = 90). In 50% of persons in the lenalidomide arm, response to therapy was noted along with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide vs observation. For the lenalidomide arm and for the observation arm, 1-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% vs 89%, 76%, and 66%, respectively. Only six deaths were notified, two in the lenalidomide arm vs four in the observation arm. In 25 patients (28%) on lenalidomid, grade 3 or 4 nonhematologic adverse events happened. Hence, in smoldering multiple myeloma, early intervention with lenalidomide markedly postpones progression to symptomatic multiple myeloma and the development of end-organ damage.
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