NICE recommends lenalidomide maintenance after auto-SCT

After 10 years of discussions, the National Institute for Health and Care Excellence (NICE) published its positive recommendation for the use of lenalidomide as maintenance treatment after autologous stem cell transplantation (auto-SCT) for patients with newly diagnosed multiple myeloma (MM).¹ These recommendations are applicable for adult patients with MM only if the dosing regimen is 10 mg per day on Days 1 to 21 of a 28‑day cycle until progressive disease in the absence of toxicities.

This update has been added since there is at present no maintenance treatment for newly diagnosed patients with MM. The current standard of care involves monitoring until the disease deteriorates. However, evidence from clinical trials indicates that lenalidomide maintenance increases both the overall survival of patients and the length of time before the condition progresses. Therefore, lenalidomide maintenance is seen as a more cost-effective option than monitoring alone, and is suitable for the UK National Health Service funding.

The main evidence for the use of lenalidomide as a maintenance therapy came from the results of the Myeloma XI trial (NCT01554852), a phase III study of 1,971 patients with newly diagnosed MM. In this trial, a subset of patients (n = 1,032) was treated with lenalidomide at the dosage recommended by NICE. Overall, patients on lenalidomide maintenance showed a significantly improved median progression-free survival of 39 months (95% CI, 36–42) vs 20 months (95% CI, 18–22; p < 0.0001). The 5-year overall survival also increased, with 61.3% (95% CI, 56.6–66.1) vs 6% (95% CI, 51.5–61.7).²