6/28/23, 11:01 PM LenDex in High-Risk Smoldering Myeloma Pathway Feedback Search Clinical Topics Home Studies LenDex in High-Risk Smoldering Myeloma LenDex in High-Risk Smoldering Myeloma Disease Multiple myeloma Trial question What is the role of lenalidomide plus dexamethasone in patients with high-risk smoldering multiple myeloma? Study design Multi-center Open label RCT Population Characteristics of study participants 55.0% female N = 119 45.0% male 119 patients (66 female, 53 male) Inclusion criteria: patients with high-risk smoldering myeloma Key exclusion criteria: hypercalcemia, bone lesions, renal failure, or anemia Interventions N=57 early treatment (induction regimen with lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4- week intervals for nine cycles, followed by a maintenance regimen with lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years) N=62 observation (no treatment until progression to symptomatic disease) https://web.pathway.md/studies/recGQ8posc4Bebhf7 1/2 6/28/23, 11:01 PM LenDex in High-Risk Smoldering Myeloma Pathway Primary outcome Survival at 5 years 94.0 % 94 78 70.5 % 47.0 % Significant decrease 23.5 % NNH = 6 0.0 % Early treatment Observation Significant decrease in survival at 5 years (94% vs. 78%; HR 0.28, 95% CI 0.09 to 0.91) Safety outcomes No significant differences in grade 1 or 2 infections, grade 1 or 2 asthenia, cumulative risk of a second primary tumor at 5 years. Significant difference in serious adverse events (12% vs. 3%). Conclusion In patients with high-risk smoldering myeloma, early treatment was superior to observation with respect to survival at 5 years. Reference Mateos MV, Hernandez MT, Giraldo P et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013 Aug 1;369(5):438-47. Open reference URL https://web.pathway.md/studies/recGQ8posc4Bebhf7 2/2