Smouldering multiple myeloma is a precursor condition that has been relegated to observation for more than 40 years on the basis of the pooled risk of progression relative to the risks of treatment. In the modern era of myeloma therapy, efficacy and toxicity of initial therapy have improved, as have tools for assessing risk of progression of this disease. The combination of these two advances has resulted in an explosion in the number of trials testing new drugs in patients with smouldering multiple myeloma, with the goal of preventing patients from developing the need for intensive treatment or of eliminating the malignant clone in totality. Two phase 3 trials have now shown a significant benefit of early intervention in the highest risk group of patients, leading to the discussion and approach described in this Viewpoint. Ongoing uncertainties include the duration of therapy, acceptable risks, and intensity of treatment (curative vs preventive), all of which are being tested in ongoing trials. Finally, common methods for risk stratification are crucial for allowing comparison across trials, and the 20/2/20 (Mayo 2018) criteria might be one such method, on the basis of their simplicity and broad availability. A focus on phase 3 trials is key to moving the field forward in a way that answers these questions and ultimately improves outcomes for patients.
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