LenDex in high-risk smoldering 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
45.0% male
N = 119
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).
Primary outcome
Survival at 3 years
94%
80%
94.0 %
70.5 %
47.0 %
23.5 %
0.0 %
Early
treatment
Observation
Significant
increase ▲
NNT = 7
Significant increase in survival at 3 years (94% vs. 80%; HR 3.22, 95% CI 1.1 to 10).
Secondary outcomes
Significant increase in survival at 5 years (94% vs. 78%; HR 3.6, 95% CI 1.1 to 11.1).
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 3 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.
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