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Previous Volume 357:2123-2132 November 22, 2007 Number 21 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by List, A. F. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

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<0.001). A complete or partial response occurred in 106 patients in the lenalidomide group (60.2%) and in 42 patients in the placebo group (24.0%, P<0.001), with a complete response in 15.9% and 3.4% of patients, respectively (P<0.001). Overall survival was significantly improved in the lenalidomide group (hazard ratio for death, 0.66; P=0.03). Grade 3 or 4 adverse events that occurred in more than 10% of patients in the lenalidomide group were neutropenia (29.5%, vs. 2.3% in the placebo group), thrombocytopenia (11.4% vs. 5.7%), and venous thromboembolism (11.4% vs. 4.6%).

Conclusions Lenalidomide plus dexamethasone is more effective than high-dose dexamethasone alone in relapsed or refractory multiple myeloma. (ClinicalTrials.gov number, NCT00424047 [ClinicalTrials.gov] .)

Source Information

From the University of Athens School of Medicine, Athens (M.D.); Alfred Hospital (A.S.) and Peter MacCallum Cancer Institute (H.M.P.) — both in Melbourne, Australia; Centre Hospitalier Universitaire Purpan, Toulouse, France (M.A.); Centre Hospitalier Hôtel-Dieu, Nantes, France (J.-L.H.); University School of Medicine, Lublin, Poland (A.D.); Hospital Universitario de Salamanca, Salamanca, Spain (J.S.M.); Medical University of Gdansk, Gdansk, Poland (A.H.); Hôpital Claude Huriez, Lille, France (T.F.); University "La Sapienza," Rome (R.F.); Fondazione Istituto Ricovero e Cura a Carattere Scientifico, Policlinico San Matteo, Pavia, Italy (A.C.); Institute of Blood Pathology and Transfusion Medicine, Lviv, Ukraine (Z.M.); and Celgene, Summit, NJ (M.O., Z.Y., J.P., J.B.Z., R.D.K.).

This article (10.1056/NEJMoa070594) was updated on July 29, 2009, at NEJM.org.

Address reprint requests to Dr. Dimopoulos at the University of Athens School of Medicine, Alexandra Hospital, Vas. Sophias 80, Athens 11528, Greece, or at mdimop{at}med.uoa.gr.

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