New Drug Regimen Outperforms Standard Myeloma Treatment

New Orleans—After a median follow-up of 37 months, older patients with newly diagnosed multiple myeloma had a significant 28% reduction in disease progression or death if they received continuous treatment with lenalidomide plus low-dose dexamethasone compared with a standard regimen of melphalan, prednisone, and thalidomide for 72 weeks. The results of the open-label phase 3 trial could change the standard of care in this patient population, according to Thierry Facon, MD, the study’s lead author, who presented the findings on Sunday during a plenary session at the American Society of Hematology annual meeting. The study included 1623 patients at 246 centers in 18 countries who were 65 years of age or older or ineligible for stem cell transplantation. The median age was 73 years, and 35% of patients were older than 75 years of age. It was the largest registration study conducted for newly diagnosed multiple myeloma patients and the first to enroll patients with renal insufficiencies. Celgene, the manufacturer of lenalidomide, sponsored the study. “This population is somewhat close to a real life population,” Dr. Facon said. Facon noted that the National Comprehensive Cancer Network recommends the use of thalidomide with melphalan and prednisone in this patient population. The safety profile of lenalidomide and low-dose dexamethasone was “manageable,” according to Facon, who added that hematological and non-hematological adverse events were “as expected.” The median progression-free survival was 25.5 months for the continuous lenalidomide plus low-dose dexamethasone group compared with 21.2 months for patients receiving melphalan, prednisone, and thalidomide for 72 weeks (hazard ratio [HR], 0.72; P=.00006). The median progression-free survival was 20.7 months for patients taking lenalidomide and low-dose dexamethasone for 72 weeks. At 3 years, 42% of patients taking continuous lenalidomide and low-dose dexamethasone had no disease progression or deathcompared with 23% in each of the other groups. The progression-free survival benefit was consistent in a majority of subgroups, according to Facon. The authors also conducted an interim analysis of overall survival when 35% of patients had died. The estimated, 4-year overall survival rates were 59% in the lenalidomide plus low-dose dexamethasone group and 51% in the melphalan, prednisone, andthalidomide (HR, 0.78; P=.017). In the past few years, studies have shown combining thalidomide or bortezomib with melphalan plus prednisone is superior to melphalan plus prednisone in elderly multiple myeloma patients who are ineligible for stem cell transplant.—Tim Casey