Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma

Meletios Dimopoulos, Andrew Spencer, Michael Attal, H. Miles Prince, Jean Luc Harousseau, Anna Dmoszynska, Jesus San Miguel, Andrzej Hellmann, Thierry Facon, Robin Foà, Alessandro Corso, Zvenyslava Masliak, Marta Olesnyckyj, Zhinuan Yu, John Patin, Jerome B. Zeldis, Robert D. Knight

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Abstract

Background: Lenalidomide is a structural analogue of thalidomide with similar but more potent biologic activity. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide plus dexamethasone in the treatment of relapsed or refractory multiple myeloma. Methods: Of 351 patients who had received at least one previous antimyeloma therapy, 176 were randomly assigned to receive 25 mg of oral lenalidomide and 175 to receive placebo on days 1 to 21 of a 28-day cycle. In addition, all patients received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles and subsequently, after the fourth cycle, only on days 1 to 4. Patients continued in the study until the occurrence of disease progression or unacceptable toxic effects. The primary end point was time to progression. Results: The time to progression was significantly longer in the patients who received lenalidomide plus dexamethasone (lenalidomide group) than in those who received placebo plus dexamethasone (placebo group) (median, 11.3 months vs. 4.7 months; P

Original languageEnglish
Pages (from-to)2123-2132
Number of pages10
JournalNew England Journal of Medicine
Volume357
Issue number21
DOIs
Publication statusPublished - Nov 22 2007

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

Dimopoulos, M., Spencer, A., Attal, M., Prince, H. M., Harousseau, J. L., Dmoszynska, A., San Miguel, J., Hellmann, A., Facon, T., Foà, R., Corso, A., Masliak, Z., Olesnyckyj, M., Yu, Z., Patin, J., Zeldis, J. B., & Knight, R. D. (2007). Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. New England Journal of Medicine, 357(21), 2123-2132. https://doi.org/10.1056/NEJMoa070594