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Lenalidomide plus Dexamethasone for High-Risk Smoldering Multiple Myeloma
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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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“…lenalidomide response, the rapidity and depth of the response in this study (Korde et al., 2015) suggest that anti-tumor activity is mostly due to carfilzomib, since lenalidomide has consistently been reported to act more slowly and have a much lower CR rate than carfilzomib (Mateos et al., 2013).”
BackgroundWhole body diffusion weighted MRI – a new view of myeloma
Messiou, C., & Kaiser, M. (2015) · British Journal of Haematology · doi:10.1111/bjh.13509 · Cited by 94
“Whole body diffusion weighted MRI – a new view of myeloma”
BackgroundPrevalence of smoldering multiple myeloma based on nationwide screening
Thorsteinsdóttir, S., Gíslason, G. K., Aspelund, T., Rögnvaldsson, S., Óskarsson, J. Þ., Sigurðardóttir, G. Á., Þórðardóttir, Á. R., Viðarsson, B., Önundarson, P. T., Agnarsson, B. A., et al. (2023) · Nature Medicine · doi:10.1038/s41591-022-02183-6 · Cited by 93
Larráyoz, M., Garcia-Barchino, M. J., Celay, J., Etxebeste, A., Jiménez, M., Pérez, C., Ordóñez, R., Cobaleda, C., Botta, C., Fresquet, V., et al. (2023) · Nature Medicine · doi:10.1038/s41591-022-02178-3 · Cited by 93
Self-citationPulte, D. D., Jansen, L., Castro, F. A., Emrich, K., Katalinic, A., Holleczek, B., Brenner, H., & the GEKID Cancer Survival Working Group (2015) · British Journal of Haematology · doi:10.1111/bjh.13537 · Cited by 92
Lust, J. A., Lacy, M. Q., Zeldenrust, S. R., Witzig, T. E., Moon‐Tasson, L. L., Dinarello, C. A., & Donovan, K. A. (2016) · American Journal of Hematology · doi:10.1002/ajh.24352 · Cited by 95
“sone compared to observation [6] demonstrating the clinical signifi-”
BackgroundLandgren, C. O., Chari, A., Cohen, Y. C., Spencer, A., Voorhees, P., Estell, J. A., Sandhu, I., Jenner, M. W., Williams, C., Cavo, M., et al. (2020) · Leukemia · doi:10.1038/s41375-020-0718-z · Cited by 102
Giuliani, M., Janji, B., & Berchem, G. (2017) · Oncotarget · doi:10.18632/oncotarget.15234 · Cited by 91
“gov demonstrated a strong anti-tumor effect of Lenalidomide when administrated alone or combined with others drugs [22, 102, 103, 106-108].”
BackgroundLópez‐Corral, L., Corchete, L. A., Sarasquete, M. E., Mateos, M., García‐Sánz, R., Fermiñán, E., Lahuerta, J. J., Bladé, J., Oriol, A., Teruel, A. I., et al. (2014) · Haematologica · doi:10.3324/haematol.2013.087809 · Cited by 90
“The criteria for defining high-risk SMM has been described previously.(18,25) In addition, 5 healthy donors”
BackgroundSelf-citationTreatment for High-Risk Smoldering Myeloma
Kristinsson, S. Y., Holmberg, E., & Blimark, C. H. (2013) · New England Journal of Medicine · doi:10.1056/nejmc1310911 · Cited by 88
Landgren, O. (2013) · Hematology · doi:10.1182/asheducation-2013.1.478 · Cited by 89
Nooka, A. K., Wang, M. L., Yee, A. J., Kaufman, J. L., Bae, J. E., Peterkin, D., Richardson, P. G. G., & Raje, N. S. (2018) · JAMA Oncology · doi:10.1001/jamaoncol.2018.3267 · Cited by 86
Novel strategies to target the ubiquitin proteasome system in multiple myeloma
Lub, S., Maes, K., Menu, E., Bruyne, E. D., Vanderkerken, K., & Valckenborgh, E. V. (2015) · Oncotarget · doi:10.18632/oncotarget.6658 · Cited by 86
“This was based on a recent study that demonstrated that treatment of high-risk SMM with lenalidomide/dexamethasone delays progression to active disease and increases overall survival [24].”
MethodWaal, E. G. M. D., Leene, M. J., Veeger, N. J. G. M., Vos, H. J., Ong, F., Smit, W. G. J. M., Hovenga, S., Hoogendoorn, M., Hogenes, M. C. H., Beijert, M., et al. (2016) · British Journal of Haematology · doi:10.1111/bjh.14291 · Cited by 83
Paiva, B., Mateos, M., Sánchez‐Abarca, L. I., Puig, N., Vídriales, M., López‐Corral, L., Corchete, L. A., Hernández, M., Bargay, J., de Arriba, F., et al. (2015) · Blood · doi:10.1182/blood-2015-10-662320 · Cited by 82
“Furthermore, the combination used in the QUIREDEX trial includes the potential antagonist effects of the immunomodulatory lenalidomide vs the immunosuppressive dexamethasone21-25; accordingly, such a potentially antagonist combinationmay represent a dilemma in the design of clinical trials investigating preemptive the…”
BackgroundMethodInfluentialSelf-citationSmoldering multiple myeloma requiring treatment: time for a new definition?
Dispenzieri, A. A., Stewart, A. K., Chanan-Khan, A. A., Rajkumar, S. V., Kyle, R. A., Fonseca, R., Kapoor, P., Bergsagel, P. L., McCurdy, A. B. R., Gertz, M. A., et al. (2013) · Blood · doi:10.1182/blood-2013-08-520890 · Cited by 83
“The most provocative study for patients with SMM is that of the PETHEMA-GEM group.(15) These authors reported on 119 patients with high-risk SMM managed in an open-label randomized controlled trial by either observation or lenalidomide and dexamethasone.”
BackgroundGonsalves, W. I., Rajkumar, S. V., Dispenzieri, A. A., Dingli, D., Timm, M., Morice, W. G., Lacy, M. Q., Buadi, F. K., Go, R. S., Leung, N., et al. (2016) · Leukemia · doi:10.1038/leu.2016.205 · Cited by 80
Ho, M., Patel, A. S., Goh, C. Y., Moscvin, M., Zhang, L., & Bianchi, G. (2020) · Leukemia · doi:10.1038/s41375-020-01051-x · Cited by 83
Evolving changes in disease biomarkers and risk of early progression in smoldering multiple myeloma
Ravi, P. K., Kumar, S. K., Larsen, J. T., Gonsalves, W. I., Buadi, F. K., Lacy, M. Q., Go, R. S., Dispenzieri, A. A., Kapoor, P., Lust, J. A., et al. (2016) · Blood Cancer Journal · doi:10.1038/bcj.2016.65 · Cited by 77
Smoldering multiple myeloma current treatment algorithms
Rajkumar, S. V., Kumar, S. K., Lonial, S., & Mateos, M. (2022) · Blood Cancer Journal · doi:10.1038/s41408-022-00719-0 · Cited by 76
“Why can we not observe patients closely for progression instead of starting on any form of therapy? In our experience conducting retrospective and prospective studies on hundreds of patients with SMM [9, 10, 27, 31, 37, 42, 52, 53], we have seen physicians reassure patients with high risk SMM that the disease is stabl…”
BackgroundSelf-citationFouquet, G., Guidez, S., Herbaux, C., de Wyngaert, Z. V., Bonnet, S., Beauvais, D., Demarquette, H., Adib, S., Hivert, B., Wémeau, M., et al. (2014) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-13-2910 · Cited by 76
“A study recently demonstrated that high-risk SMM seemed to highly benefit from early treatment approach in terms of prolonged TTMM and more importantly OS, rather than to wait for development of symptomatic MM to start treatment (20).”
Multiple Myeloma, Version 2.2016
Anderson, K. C., Alsina, M., Atanackovic, D., Biermann, J. S., Chandler, J. C., Costello, C. L., Djulbegović, B., Fung, H. C. H., Gasparetto, C., Godby, K. N., et al. (2015) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2015.0167 · Cited by 75
Monoclonal Gammopathy of Undetermined Significance and Smoldering Multiple Myeloma
Kyle, R. A., Miguel, J. F. S., Mateos, M., & Rajkumar, S. V. (2014) · Hematology/Oncology Clinics of North America · doi:10.1016/j.hoc.2014.06.005 · Cited by 73
Self-citationPianko, M. J., Terpos, E., Roodman, G. D., Divgi, C. R., Zweegman, S., Hillengaß, J., & Lentzsch, S. (2014) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-14-1692 · Cited by 72
Immune biomarkers of response to immunotherapy in patients with high-risk smoldering myeloma
Sklavenitis-Pistofidis, R., Aranha, M. P., Redd, R. A., Baginska, J., Haradhvala, N. J., Hallisey, M., Dutta, A. K., Savell, A., Varmeh, S., Heilpern-Mallory, D., et al. (2022) · Cancer Cell · doi:10.1016/j.ccell.2022.10.017 · Cited by 70
Self-citationSmoldering multiple myeloma risk factors for progression: a Danish population‐based cohort study
Sørrig, R., Klausen, T. W., Salomo, M., Vangsted, A. J., Østergaard, B., Gregersen, H., Frølund, U. C., Andersen, N. F., Helleberg, C., Andersen, K., et al. (2015) · European Journal Of Haematology · doi:10.1111/ejh.12728 · Cited by 68
“In the PETHEMA clinical trial, high-risk SMM was defined by BMPC% ≥10, high M-protein (≥20 g/L for IgA, ≥30 g/L for IgG, or ≥1 g/24 h for urinary Bence-Jones protein) or one of these two plus ≥95% aberrant plasma cells and immunoparesis was defined as a reduction of at least 25% in 1 or 2 uninvolved immunoglobulins be…”
BackgroundMolecular pathogenesis of multiple myeloma
Furukawa, Y., & Kikuchi, J. (2015) · International Journal of Clinical Oncology · doi:10.1007/s10147-015-0837-0 · Cited by 67
“[58, 59].”
Evolving M-protein pattern in patients with smoldering multiple myeloma: impact on early progression
de Larrea, C. F., Isola, I., Pereira, A., Cibeira, M. T., Magnano, L., Tovar, N., Rodríguez‐Lobato, L. G., Calvo, X., Aróstegui, J. I., Díaz, T., et al. (2018) · Leukemia · doi:10.1038/s41375-018-0013-4 · Cited by 67
Self-citationEvolving diagnostic criteria for multiple myeloma
Rajkumar, S. V. (2015) · Hematology · doi:10.1182/asheducation-2015.1.272 · Cited by 66
Offidani, M., Corvatta, L., Morè, S., Nappi, D., Martinelli, G., Olivieri, A., & Cerchione, C. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2020.624661 · Cited by 64
MGUS and Smoldering Multiple Myeloma: Diagnosis and Epidemiology
Mateos, M., & Landgren, O. (2016) · Cancer treatment and research · doi:10.1007/978-3-319-40320-5_1 · Cited by 64
Self-citationSolimando, A. G., Vià, M. D., Cicco, S., Leone, P., Lernia, G. D., Giannico, D., Desantis, V., Frassanito, M. A., Morizio, A., Tascon, J. D., et al. (2019) · Journal of Clinical Medicine · doi:10.3390/jcm8070997 · Cited by 61
Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies
Keren, D. F., Bocsi, G., Billman, B. L., Etzell, J., Faix, J. D., Kumar, S., Lipe, B. C., McCudden, C. R., Montgomery, R., Murray, D. L., et al. (2021) · Archives of Pathology & Laboratory Medicine · doi:10.5858/arpa.2020-0794-cp · Cited by 65
Gene expression profile alone is inadequate in predicting complete response in multiple myeloma
Amin, S. B., Yip, W.-K., Minvielle, S., Broyl, A., Li, Y., Hanlon, B. M., Swanson, D. M., Shah, P. K., Moreau, P., van der Holt, B., et al. (2014) · Leukemia · doi:10.1038/leu.2014.140 · Cited by 61
van de Donk, N. W. C. J., Mutis, T., Poddighe, P. J., Lokhorst, H. M., & Zweegman, S. (2016) · International Journal of Laboratory Hematology · doi:10.1111/ijlh.12504 · Cited by 62
Messiou, C., Porta, N., Sharma, B., Levine, D., Koh, D., Boyd, K. D., Pawlyn, C., Riddell, A. M., Downey, K., Croft, J., et al. (2021) · Radiology Imaging Cancer · doi:10.1148/rycan.2021210048 · Cited by 61
Kumar, S., Baizer, L., Callander, N. S., Giralt, S. A., Hillengass, J., Freidlin, B., Hoering, A., Richardson, P. G., Schwartz, E. I., Reiman, A., et al. (2022) · Blood Cancer Journal · doi:10.1038/s41408-022-00695-5 · Cited by 62
Mateos, M., Hernández, M.-T., Salvador, C., de la Rubia, J., de Arriba, F., López‐Corral, L., Rosiñol, L., Paiva, B., Palomera, L., Bargay, J., et al. (2022) · European Journal of Cancer · doi:10.1016/j.ejca.2022.07.030 · Cited by 59
Self-citation
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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