TY - JOUR
T1 - Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma
AU - Dimopoulos, Meletios
AU - Spencer, Andrew
AU - Attal, Michael
AU - Prince, H. Miles
AU - Harousseau, Jean Luc
AU - Dmoszynska, Anna
AU - San Miguel, Jesus
AU - Hellmann, Andrzej
AU - Facon, Thierry
AU - Foà, Robin
AU - Corso, Alessandro
AU - Masliak, Zvenyslava
AU - Olesnyckyj, Marta
AU - Yu, Zhinuan
AU - Patin, John
AU - Zeldis, Jerome B.
AU - Knight, Robert D.
PY - 2007/11/22
Y1 - 2007/11/22
N2 - 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
AB - 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
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U2 - 10.1056/NEJMoa070594
DO - 10.1056/NEJMoa070594
M3 - Article
C2 - 18032762
AN - SCOPUS:36349023319
VL - 357
SP - 2123
EP - 2132
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 21
ER -