The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.
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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Citations
Cites
The International Myeloma Working Group (2003) · British Journal of Haematology · doi:10.1046/j.1365-2141.2003.04355.x · Cited by 2,367
Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma
Dimopoulos, M., Spencer, A., Attal, M., Prince, H. M., Harousseau, J.-L., Dmoszynska, A., Miguel, J. S., Hellmann, A., Facon, T., Foà, R., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa070594 · Cited by 1,450
Self-citationLenalidomide plus Dexamethasone for Relapsed Multiple Myeloma in North America
Weber, D. M., Chen, C., Niesvizky, R., Wang, M., Belch, A., Stadtmauer, E. A., Siegel, D., Borrello, I., Rajkumar, S. V., Chanan-Khan, A. A., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa070596 · Cited by 1,233
Rajkumar, S. V., Harousseau, J.-L., Durie, B., Anderson, K. C., Dimopoulos, M., Kyle, R., Blade, J., Richardson, P., Orlowski, R., Siegel, D., et al. (2011) · Blood · doi:10.1182/blood-2010-10-299487 · Cited by 1,036
Self-citationRajkumar, S. V., Jacobus, S., Callander, N. S., Fonseca, R., Vesole, D. H., Williams, M. E., Abonour, R., Siegel, D. S., Katz, M., & Greipp, P. R. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(09)70284-0 · Cited by 933
Clinical Course and Prognosis of Smoldering (Asymptomatic) Multiple Myeloma
Kyle, R. A., Remstein, E. D., Therneau, T. M., Dispenzieri, A., Kurtin, P. J., Hodnefield, J. M., Larson, D. R., Plevak, M. F., Jelinek, D. F., Fonseca, R., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa070389 · Cited by 921
Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma
Palumbo, A. P., Hájek, R., Delforge, M., Kropff, M. H., Petrucci, M. T., Catalano, J. V., Gisslinger, H., Wiktor-Jędrzejczak, W., Zodelava, M., Weisel, K. C., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1112704 · Cited by 748
Self-citationPérez-Persona, E., Vidriales, M.-B., Mateo, G., García-Sanz, R., Mateos, M.-V., de Coca, A. G., Galende, J., Martín-Nuñez, G., Alonso, J. M., de las Heras, N., et al. (2007) · Blood · doi:10.1182/blood-2007-05-088443 · Cited by 579
Self-citationThalidomide Alone or With Dexamethasone for Previously Untreated Multiple Myeloma
Weber, D., Rankin, K., Gavino, M., Delasalle, K. B., & Alexanian, R. (2002) · Journal of Clinical Oncology · doi:10.1200/jco.2003.03.139 · Cited by 565
Dispenzieri, A. A., Kyle, R. A., Katzmann, J. A., Therneau, T. M., Larson, D. R., Benson, J. T., Clark, R. J., Melton, L. J., Gertz, M. A., Kumar, S. K., et al. (2007) · Blood · doi:10.1182/blood-2007-08-108357 · Cited by 432
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International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma
Rajkumar, S. V., Dimopoulos, M. A., Palumbo, A., Blade, J., Merlini, G., Mateos, M.-V., Kumar, S., Hillengass, J., Kastritis, E., Richardson, P., et al. (2014) · The Lancet Oncology · doi:10.1016/s1470-2045(14)70442-5 · Cited by 4,978
Self-citationCrosby, D., Bhatia, S., Brindle, K. M., Coussens, L. M., Dive, C., Emberton, M., Esener, S., Fitzgerald, R. C., Gambhir, S. S., Kuhn, P., et al. (2022) · Science · doi:10.1126/science.aay9040 · Cited by 1,379
“Clinical trials suggest that patients who undergo early detection of MGUS progression may benefit from therapeutic intervention at the stage of smoldering myeloma rather than waiting for symptomatic malignant myeloma with end-organ damage (17).”
Kumar, S. K., Rajkumar, S. V., Kyle, R. A., van Duin, M., Sonneveld, P., Mateos, M., Gay, F., & Anderson, K. C. (2017) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2017.46 · Cited by 1,261
Self-citationDiagnosis and Management of Multiple Myeloma
Cowan, A. J., Green, D. J., Kwok, M., Lee, S., Coffey, D. G., Holmberg, L., Tuazon, S. A., Gopal, A. K., & Libby, E. N. (2022) · JAMA · doi:10.1001/jama.2022.0003 · Cited by 1,082
Multiple myeloma: 2020 update on diagnosis, risk‐stratification and management
Rajkumar, S. V. (2020) · American Journal of Hematology · doi:10.1002/ajh.25791 · Cited by 830
“cial in patients with high risk smoldering multiple myeloma, and is discussed separately.(90,91) There is an ongoing “cure versus control” debate on whether we should treat multiple myeloma with an aggressive multi-”
BackgroundResult
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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