- Among patients with high-risk smoldering multiple myeloma (SMM), a regimen of elotuzumab, lenalidomide, and dexamethasone prevented progression to overt MM in all patients with 3 years of follow-up.
Why this matters
- Progression to overt MM is associated with worse outcomes compared with SMM.
- Single-group trial phase 2 trial of 50 patients (median age, 60 years) with high-risk SMM.
- In the first two 28-day treatment cycles, patients received elotuzumab plus lenalidomide 25 mg. For cycles 3-8, patients received elotuzumab and dexamethasone. After completing 8 treatment cycles or best response, patients had the option to undergo stem cell mobilization to harvest cells for future transplant. Participants were then allowed to continue receiving maintenance elotuzumab plus lenalidomide.
- Funding: Celgene; Bristol-Myers Squibb.
- At 36-months of follow-up, PFS was 95% and event-free survival was 100%.
- No patients progressed to overt MM.
- The overall response rate (ORR) was 84%, including 3 complete remissions (6%), 18 very good partial responses (37%), and 20 partial responses (41%).
- The median time to response was 2.8 months.
- The most common adverse events were fatigue (92%), diarrhea (72%), and hyperglycemia (62%).
- Single-group trial.
- Small patient enrollment.
- Overall survival data not yet available.