Loading...
Observation without treatment until disease progression has been the standard of care for patients with smoldering multiple myeloma (SMM). To test the ability of lenalidomide plus dexamethasone therapy to delay the time to progression (TTP) to symptomatic myeloma, investigators conducted a randomized, open-label, phase III trial involving patients with high-risk SMM (defined as ≥10% marrow plasma cells, immunoglobulin G paraprotein ≥3 gm/dL or immunoglobulin A ≥2 gm/dL, or urinary paraprotein >1 gm/24 hours).
A total of 119 patients were randomized to observation or induction treatment with lenalidomide (25 mg/day for 21 days) and dexamethasone (20 mg on days 1–4 and 12–15) in 28-day cycles, followed after 9 cycles by maintenance therapy wit…