Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial
Open accessAbstract
Background High-dose dexamethasone is a mainstay of therapy for multiple myeloma. We studied whether low-dose dexamethasone in combination with lenalidomide is non-inferior to and has lower toxicity than high-dose dexamethasone plus lenalidomide.Methods Patients with untreated symptomatic myeloma were randomly assigned in this open-label non-inferiority trial to lenalidomide 25 mg on days 1-21 plus dexamethasone 40 mg on days 1-4, 9-12, and 17-20 of a 28-day cycle (high dose), or lenalidomide given on the same schedule with dexamethasone 40 mg on days 1, 8, 15, and 22 of a 28-day cycle (low dose). After four cycles, patients could discontinue therapy to pursue stem-cell transplantation or continue treatment until disease progression. The primary endpoint was response rate after four cycles assessed with European Group for Blood and Bone Marrow Transplant criteria. The non-inferiority margin was an absolute difference of 15% in response rate. Analysis was by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00098475.Findings 445 patients were randomly assigned: 223 to high-dose and 222 to low-dose regimens. 169 (79%) of 214 patients receiving high-dose therapy and 142 (68%) of 205 patients on low-dose therapy had complete or partial response within four cycles (odds ratio 1.75, 80% CI 1.30-2.32; p=0.008). However, at the second interim analysis at 1 year, overall survival was 96% (95% CI 94-99) in the low-dose dexamethasone group compared with 87% (82-92) in the high-dose group (p=0.0002). As a result, the trial was stopped and patients on high-dose therapy were crossed over to low-dose therapy. 117 patients (52%) on the high-dose regimen had grade three or worse toxic effects in the first 4 months, compared with 76 (35%) of the 220 on the low-dose regimen for whom toxicity data were available (p=0.0001), 12 of 222 on high dose and one of 220 on low-dose dexamethasone died in the first 4 months (p=0.003). The three most common grade three or higher toxicities were deep-vein thrombosis, 57 (26%) of 223 versus 27 (12%) of 220 (p=0.0003); infections including pneumonia, 35 (16%) of 223 versus 20 (9%) of 220 (p=0.04), and fatigue 33 (15%) of 223 versus 20 (9%) of 220 (p=0.08), respectively.Interpretation Lenalidomide plus low-dose dexamethasone is associated with better short-term overall survival and with lower toxicity than lenalidomide plus high-dose dexamethasone in patients with newly diagnosed myeloma.Funding National Cancer Institute, Rockville, MD, USA.
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Low-dose dexamethasone (once weekly 40 mg dose) is associated with less dexamethasone-related toxicity than more intensive dosing scheme without compromising efficacy.
“Low-dose dexamethasone (i.e., once weekly 40 mg dose) is associated with less dexamethasone-related toxicity than more intensive dosing scheme without compromising efficacy [48].”
From Epidemiology, Staging, and Management of Multiple Myeloma (2021) · cites this paper as [48]
The Methods (Procedures; page unavailable) specify 40 mg dexamethasone once weekly in the low-dose arm. The Results and Discussion report less toxicity and no worse progression or survival outcomes with low-dose treatment, but the Results also find a significantly lower response rate after four cycles (68.3% versus 79%). Thus, “without compromising efficacy” is too broad, and the evidence is limited to treatment with lenalidomide in newly diagnosed myeloma. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn an ECOG randomized trial, low-dose dexamethasone was associated with better overall survival and significantly less toxicity.
“In a randomized trial conducted by the Eastern Cooperative Oncology Group (ECOG), the low-dose dexamethasone approach was associated with superior OS and significantly lower toxicity.110”
From Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management (2024) · cites this paper as [110]
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“, once weekly 40 mg dose) is associated with less dexamethasone-related toxicity than more intensive dosing scheme without compromising efficacy [48].”
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- Authors
- Rajkumar, 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.
- Affiliations
- Mayo Clinic (US)
- Dana-Farber Cancer Institute (US)
- University of Wisconsin–Madison (US)
- Saint Vincent's Catholic Medical Center (US)
- University of Virginia Health System (US)
- Indiana University Health (US)
- Hackensack University Medical Center (US)
- International Myeloma Foundation (US)
- Corresponding author
- Rajkumar, S Vincent
- ORCID
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2010-01
- Volume
- 11
- Issue
- 1
- Pages
- 29-37
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC3042271
- OpenAlex
- W2169336006
- Cited by
- 933
- References
- 35
- Citations by year
- 2026: 19 · 2025: 19 · 2024: 32 · 2023: 25 · 2022: 45 · 2021: 42 · 2020: 38 · 2019: 29 · 2018: 48 · 2017: 45 · 2016: 56 · 2015: 66 · 2014: 81 · 2013: 109 · 2012: 103
- FWCI
- 61.54
- Type
- journal article
- Language
- en
- Update notices
- erratum (2010-01-01)
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- U.S. Department of Health and Human Services
- National Institutes of Health
- National Cancer Institute (U10CA066636, CA-23318, CA13650, R01CA093842, CA66636, U10CA013650, CA 93842, U10CA023318, U10CA021115, CA 21115)
- 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
- multiple myeloma, lenalidomide, dexamethasone, high-dose dexamethasone, low-dose dexamethasone, initial treatment, non-inferiority, overall survival, response rate, treatment toxicity, stem cell transplantation
- MeSH terms
- Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Multiple Myeloma, Thalidomide, Time Factors, Proportional Hazards Models, Treatment Outcome, Risk Assessment, Kaplan-Meier Estimate, Early Termination of Clinical Trials
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