We wanted to see whether we could stop the treatment of lenalidomide maintenance in selected patients with multiple myeloma after high-dose therapy. So we designed the study in which patients who had received at least three years of lenalidomide maintenance after high-dose therapy and had at least three measurements of minimal residual disease by next-generation flow who were negative at the level of 10 to the minus 5, six months apart, and a negative PET-CT were asked to participate in a study in which we would discontinue lenalidomide and follow the patients both with blood and urine tests but also with serial bone marrow assessments...
We wanted to see whether we could stop the treatment of lenalidomide maintenance in selected patients with multiple myeloma after high-dose therapy. So we designed the study in which patients who had received at least three years of lenalidomide maintenance after high-dose therapy and had at least three measurements of minimal residual disease by next-generation flow who were negative at the level of 10 to the minus 5, six months apart, and a negative PET-CT were asked to participate in a study in which we would discontinue lenalidomide and follow the patients both with blood and urine tests but also with serial bone marrow assessments. The plan was to see whether we would have a sustained MRD negativity despite the discontinuation of lenalidomide. If a patient became MRD positive, we would reinstitute lenalidomide alone and follow the patient. So what we saw is that with a median follow-up of approximately three years, two and a half years after discontinuation of lenalidomide, about 12% of the patients had conversion to MRD positivity. So we are confident that this cutoff of sustained MRD negativity for at least three years of lenalidomide may be a meaningful way to evaluate the discontinuation of maintenance in myeloma patients.
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