Randomized trial of lenalidomide versus observation in smoldering multiple myeloma
Open accessAbstract
PURPOSE: Observation is the current standard of care for smoldering multiple myeloma. We hypothesized that early intervention with lenalidomide could delay progression to symptomatic multiple myeloma. METHODS: We conducted a randomized trial that assessed the efficacy of single-agent lenalidomide compared with observation in patients with intermediate- or high-risk smoldering multiple myeloma. Lenalidomide was administered orally at a dose of 25 mg on days 1 to 21 of a 28-day cycle. The primary end point was progression-free survival, with disease progression requiring the development of end-organ damage attributable to multiple myeloma and biochemical progression. RESULTS: One hundred eighty-two patients were randomly assigned—92 patients to the lenalidomide arm and 90 to the observation arm. Median follow-up is 35 months. Response to therapy was observed in 50% (95% CI, 39% to 61%) of patients in the lenalidomide arm, with no responses in the observation arm. Progression-free survival was significantly longer with lenalidomide compared with observation (hazard ratio, 0.28; 95% CI, 0.12 to 0.62; P = .002). One-, 2-, and 3-year progression-free survival was 98%, 93%, and 91% for the lenalidomide arm versus 89%, 76%, and 66% for the observation arm, respectively. Only six deaths have been reported, two in the lenalidomide arm versus four in the observation arm (hazard ratio for death, 0.46; 95% CI, 0.08 to 2.53). Grade 3 or 4 nonhematologic adverse events occurred in 25 patients (28%) on lenalidomide. CONCLUSION: Early intervention with lenalidomide in smoldering multiple myeloma significantly delays progression to symptomatic multiple myeloma and the development of end-organ damage.
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Several trials have reported the advantages and risks of early intervention in high-risk SMM.
“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 [105]
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Emran, T. B., Shahriar, A., Mahmud, A. R., Rahman, T., Abir, M. H., Siddiquee, M. F. R., Ahmed, H., Rahman, N., Nainu, F., Wahyudin, E., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.891652 · Cited by 606 · see citing works
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- Authors
- Lonial, S., Jacobus, S., Fonseca, R., Weiss, M., Kumar, S., Orlowski, R. Z., Kaufman, J. L., Yacoub, A. M., Buadi, F. K., O’Brien, T., Matous, J. V., Anderson, D. M., Emmons, R. V., Mahindra, A., Wagner, L. I., Dhodapkar, M. V., & Rajkumar, S. V.
- Affiliations
- Emory University (US)
- Dana-Farber Cancer Institute (US)
- Mayo Clinic, Scottsdale, AZ
- ThedaCare (US)
- Mayo Clinic (US)
- The University of Texas MD Anderson Cancer Center (US)
- The University of Kansas Cancer Center (US)
- MetroHealth Medical Center (US)
- Colorado Blood Cancer Institute (US)
- Park Nicollet Clinic (US)
- University of Louisville (US)
- Scripps Clinic (US)
- Wake Forest University Health Sciences (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2020-04-10
- Volume
- 38
- Issue
- 11
- Pages
- 1126-1137
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC7145586
- OpenAlex
- W2981617674
- Cited by
- 908
- References
- 6
- Citations by year
- 2026: 40 · 2025: 41 · 2024: 52 · 2023: 37 · 2022: 60 · 2021: 44 · 2020: 47 · 2019: 24 · 2018: 163 · 2017: 108 · 2016: 22 · 2015: 3 · 2014: 11 · 2013: 6 · 2012: 10
- FWCI
- 30.86
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR001863)
- National Cancer Institute (U10CA180820, UG1CA189805, U10CA180888, UG1CA189828, U10CA180790, UG1CA189863, U10CA180858, U10CA180794, U10CA180826, R01CA107476, UG1CA189870, R35CA197603, U10CA180853, U10CA180864, R01CA168762, P30CA016672, P50CA186781)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
- Keywords
- smoldering multiple myeloma, lenalidomide, early intervention, progression-free survival, target organ damage, biochemical progression
- MeSH terms
- Smoldering Multiple Myeloma, Lenalidomide, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Quality of Life
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