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Lenalidomide plus Dexamethasone for Relapsed Multiple Myeloma in North America
Open accessAbstract
BACKGROUND: Lenalidomide, an oral immunomodulatory drug that is similar to thalidomide but has a different safety profile, has clinical activity in relapsed or refractory multiple myeloma. METHODS: Patients in the United States and Canada who had received at least one previous therapy for multiple myeloma but who required additional treatment were randomly assigned to receive either 25 mg of lenalidomide or placebo on days 1 to 21 of a 28-day cycle. Both groups also received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles. After the fourth cycle, 40 mg of dexamethasone was administered only on days 1 to 4. Safety, clinical response, time to progression, and overall survival were assessed. RESULTS: We assigned 177 patients to the lenalidomide group and 176 to the placebo group. Complete, near-complete, or partial responses occurred in 108 patients (61.0%) in the lenalidomide group and in 35 patients (19.9%) in the placebo group (P<0.001); complete responses occurred in 14.1% and 0.6%, respectively (P<0.001). The median time to progression was 11.1 months in the lenalidomide group and 4.7 months in the placebo group (P<0.001). Median overall survival times in the two groups were 29.6 months and 20.2 months, respectively (P<0.001). Grade 3 or 4 adverse events were reported in 85.3% of the lenalidomide group and in 73.1% of the placebo group; these events resulted in study discontinuation in 19.8% and 10.2%, respectively. Grade 3 or 4 neutropenia and venous thromboembolism were more common in the lenalidomide group than in the placebo group (41.2% vs. 4.6% and 14.7% vs. 3.4%, respectively; P<0.001 for both comparisons). CONCLUSIONS: Lenalidomide plus dexamethasone is superior to placebo plus dexamethasone in patients with relapsed or refractory multiple myeloma. (ClinicalTrials.gov number, NCT00056160 [ClinicalTrials.gov].).
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“in combination with dexamethasone, it became a first-line treatment for newly diagnosed multiple myeloma (weber et al. 2007).”
From From serendipity to strategy: molecular glue degraders in cancer therapeutics (2025) · cites this paper as weber et al. 2007
In the citing paper
“In patients with newly diagnosed MM, ORRs are even higher, with up to 90% of patients responding to the combination of lenalidomide and dexamethasone26.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [26]
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Metadata
- Authors
- 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., Lonial, S., Yu, Z., Patin, J., Olesnyckyj, M., Zeldis, J. B., & Knight, R. D.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Princess Margaret Cancer Centre (CA)
- Cross Cancer Institute (CA)
- University of Pennsylvania (US)
- Hackensack University Medical Center (US)
- Sidney Kimmel Comprehensive Cancer Center (US)
- Mayo Clinic (US)
- Roswell Park Comprehensive Cancer Center (US)
- Emory University (US)
- Celgene (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2007-11-22
- Volume
- 357
- Issue
- 21
- Pages
- 2133-2142
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2021954218
- Cited by
- 1,233
- References
- 13
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 14 · 2023: 36 · 2022: 41 · 2021: 35 · 2020: 31 · 2019: 46 · 2018: 57 · 2017: 69 · 2016: 83 · 2015: 74 · 2014: 77 · 2013: 126 · 2012: 111
- FWCI
- 62.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- 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
- lenalidomide, dexamethasone, relapsed multiple myeloma, refractory multiple myeloma, immunomodulators, combination chemotherapy, complete response, time to progression, overall survival, neutropenia, venous thromboembolism, adverse events, North America, thalidomide analogues, treatment efficacy and safety
- MeSH terms
- Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Double-Blind Method, Female, Glucocorticoids, Humans, Immunologic Factors, Male, Middle Aged, Multiple Myeloma, Recurrence, Thalidomide, Survival Analysis, Disease Progression
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