E3A06: lenalidomide versus observation in smouldering multiple myeloma
Lenalidomide alone delayed progression to active myeloma in people with intermediate- or high-risk smouldering disease, but side effects led many to stop, and it did not improve survival.
Overview
Phase 2/3 trial randomising 182 patients with intermediate- or high-risk smouldering myeloma to lenalidomide 25 mg or observation.
Three-year progression-free survival was 91 percent with lenalidomide against 66 percent with observation (hazard ratio 0.28), with the largest benefit in high-risk patients; about half of treated patients discontinued for toxicity.
- Three-year progression-free survival 91 percent vs 66 percent; hazard ratio 0.28.
- Grade 3 to 4 adverse events in 28 percent of the lenalidomide arm.
Lenalidomide showed that intervening before symptoms can delay end-organ damage, supporting later trials such as AQUILA, but tolerability limits its use as a single agent.
- No overall survival benefit shown.
- Progression was defined by end-organ damage, and imaging at baseline was not modern PET or MRI in all patients.
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