Does Revlimid® Warrant a Change in Standard of Care for Smoldering Multiple Myeloma

Revlimid® (lenalidomide) significantly delayed disease progression in patients with smoldering multiple myeloma (SMM), according to a study published in the Journal of Clinical Oncology.

The current standard of care for SMM is observation without therapy; however, the researchers said the findings support “early intervention” with lenalidomide in this patient cohort, changing the standard of care.

This large randomized clinical trial assessed the efficacy of single-agent lenalidomide versus observation in 182 patients with intermediate- or high-risk SMM. Patients received lenalidomide 25 mg orally on days one to 21 of a 28-day cycle (n=92) or observation (n=90).

Delayed disease progression with lenalidomide

After a median follow-up of 35 months, treatment response was 50% in the lenalidomide cohort (95% CI, 39-61), and there were zero responses in the observation arm. Progression-free survival (PFS; primary endpoint) was significantly longer with lenalidomide (hazard ratio [HR] = 0.28; 95% CI, 0.12-0.62; P=0.002). One-, two-, and three-year PFS was 98%, 93%, and 91% in the lenalidomide group versus 89%, 76%, and 66% in the observation arm, respectively.

Six deaths occurred: two in the lenalidomide arm and four in the observation arm (HR=0.46; 95% CI, 0.08-2.53). Grade 3/4 non-hematologic adverse events occurred in 25 patients (28%) receiving lenalidomide.