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Lenalidomide plus Dexamethasone for High-Risk Smoldering Multiple Myeloma
Open accessAbstract
BACKGROUND: For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. METHODS: In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (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 (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety. RESULTS: After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P=0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower. CONCLUSIONS: Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival. (Funded by Celgene; ClinicalTrials.gov number, NCT00480363.).
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“Early therapy with lenalidomide and dexamethasone or single-agent lenalidomide is beneficial in patients with high risk smoldering multiple myeloma, and is discussed separately.104,105”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [104]
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“A randomized trial conducted in Spain found that patients with high risk SMM had significant prolongation of PFS and OS with Rd compared with observation.104,197”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [104]
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“Several trials have reported the advantages and risks of early intervention in high risk SMM.105-112”
From Evolution of Multiple Myeloma from a Genomic Perspective (2026) · cites this paper as [106]
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Metadata
- Authors
- Mateos, M.-V., Hernández, M.-T., Giraldo, P., de la Rubia, J., de Arriba, F., Corral, L. L., Rosiñol, L., Paiva, B., Palomera, L., Bargay, J., Oriol, A., Prosper, F., López, J., Olavarría, E., Quintana, N., García, J.-L., Bladé, J., Lahuerta, J.-J., & San Miguel, J.-F.
- Affiliations
- Consejo Superior de Investigaciones Científicas (ES)
- Universidad de Salamanca (ES)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2013-08
- Volume
- 369
- Issue
- 5
- Pages
- 438-447
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2144930991
- Semantic Scholar
- 26670ff667b1b637856dff4325d13f38e1b7d641
- Cited by
- 1,171
- References
- 29
- Citations by year
- 2026: 23 · 2025: 36 · 2024: 37 · 2023: 29 · 2022: 64 · 2021: 47 · 2020: 63 · 2019: 52 · 2018: 195 · 2017: 145 · 2016: 82 · 2015: 57 · 2014: 63 · 2013: 26
- FWCI
- 54.54
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Hispana (publishedVersion, cc-by-nc-nd)
- Gredos (University of Salamanca) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
- Keywords
- smoldering multiple myeloma, lenalidomide, dexamethasone, early treatment, time to progression, overall survival, maintenance therapy, induction therapy, high-risk myeloma
- MeSH terms
- Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multiple Myeloma, Risk, Thalidomide, Survival Rate, Disease Progression, Induction Chemotherapy
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