07 November 2019

A trial of the cancer drug lenalidomide for patients with high-risk ‘smouldering’ multiple myeloma has shown positive results, US researchers have reported.

Dr Vincent Rajkumar and his team at the Mayo Clinic in Rochester, Minnesota, USA, carried out the largest randomised trial to date in asymptomatic patients with smouldering multiple myeloma.

Currently, patients with smouldering multiple myeloma, an early precursor to multiple myeloma, are observed regularly but not given any therapy. Publishing their study in the Journal of Clinical Oncology, the researchers write: “We hypothesised that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma.”

Their trial assigned 182 patients to either lenalidomide or observation. 25mg of the drug was given orally on days 1 to 21 of a 28-day cycle. After a median follow-up of 35 months, progression-free survival was 72% longer in the lenalidomide group. One, two, and three-year progression-free survival was 98%, 93%, and 91% respectively for the lenalidomide group, versus 89%, 76%, and 66% for the observation group.

Serious adverse events occurred in 28% of the lenalidomide patients, but many of these were controlled by reducing the lenalidomide dose.

The authors write: “Types of early therapy for smouldering multiple myeloma can take two different approaches. First, one can take a prevention approach with low-intensity therapy directed at clonal control or, second, one can take a more intensive treatment approach for which the goal is the eradication of the malignant clone.

“[In this study] early intervention with lenalidomide significantly delayed progression to symptomatic multiple myeloma and the development of end-organ damage.”

Dr Rajkumar commented: “Our findings are in line with a smaller trial in 2015 by researchers in Spain. In conjunction with the Spanish data, our findings support early therapy for patients with high-risk smouldering multiple myeloma.”



Lonial, S., Jacobus, S., Fonseca, R., Weiss, M., Kumar, S., Orlowski, R.Z., Kaufman, J.L., Yacoub, A.M., Buadi, F.K., O'Brien, T., Matous, J.V., Anderson, D.M., Emmons, R.V., Mahindra, A., Wagner, L.I., Dhodapkar, M.V., Rajkumar, S.V. (2019) “Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma”, Journal of Clinical Oncology, doi: 10.1200/JCO.19.01740


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