# E3A06: lenalidomide versus observation in smouldering multiple myeloma

Source: https://onco.cc/key-papers/paper-e3a06-lenalidomide-smouldering-lonial-jco-2020/  
OnCo record `paper-e3a06-lenalidomide-smouldering-lonial-jco-2020` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: Journal of Clinical Oncology
- Year: 2020
- DOI: 10.1200/JCO.19.01740
- Authors: Lonial S, Jacobus S, Fonseca R, et al.
- Findings: 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.
- What it means: 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.
- Caveats: 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.

## Sources

- J Clin Oncol 2020: https://doi.org/10.1200/JCO.19.01740
- PubMed: https://pubmed.ncbi.nlm.nih.gov/31652094/

## Connected records

- cancers: [Smouldering multiple myeloma](https://onco.cc/cancers/smouldering-myeloma/)
- drugs: [Lenalidomide](https://onco.cc/drugs/lenalidomide/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

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