Cited by 1,233Multiple Myeloma Research and TreatmentsBone health and treatmentsProtein Degradation and Inhibitors

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Lenalidomide plus Dexamethasone for Relapsed Multiple Myeloma in North America

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Weber, Donna M., Chen, Christine, Niesvizky, Ruben, Wang, Michael, Belch, Andrew, Stadtmauer, Edward A., Siegel, David, Borrello, Ivan, Rajkumar, S. Vincent, Chanan-Khan, Asher Alban, Lonial, Sagar, Yu, Zhinuan, Patin, John, Olesnyckyj, Marta, Zeldis, Jerome B., Knight, Robert D.·2007·New England Journal of Medicine

DOI 10.1056/nejmoa070596

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Abstract

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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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: Chen, Christine
Wang, Michael
Belch, Andrew
Stadtmauer, Edward A.
Siegel, David
Borrello, Ivan
Rajkumar, S. Vincent
Chanan-Khan, Asher Alban
Lonial, Sagar
Zeldis, Jerome B.
Knight, Robert D.
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
DOI: 10.1056/nejmoa070596
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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Lenalidomide plus Dexamethasone for Relapsed Multiple Myeloma in North America

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