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Blood, 1 December 2008, Vol. 112, No. 12, pp. 4445-4451. Prepublished online as a Blood First Edition Paper on September 17, 2008; DOI 10.1182/blood-2008-02-141614. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2008-02-141614v1 112/12/4445    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Wang, M. Articles by Weber, D. M. Search for Related Content PubMed PubMed Citation Articles by Wang, M. Articles by Weber, D. M. Related Collections Neoplasia Free Research Articles Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure Michael Wang1, Meletios A. Dimopoulos2, Christine Chen3, M. Teresa Cibeira4, Michel Attal5, Andrew Spencer6, S. Vincent Rajkumar7, Zhinuan Yu8, Marta Olesnyckyj8, Jerome B. Zeldis8, Robert D. Knight8, and Donna M. Weber1 1 Department of Lymphoma and Myeloma, M. D. Anderson Cancer Center, Houston, TX; 2 Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece; 3 Department of Medicine, Princess Margaret Hospital, Toronto, ON; 4 Hematology Department, Institute of Hematology and Oncology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain; 5 Division of Hematology, Centre Hospitalier Université de Purpan, Toulouse, France; 6 Department of Malignant Hematology and Stem Cell Transplantation Service, The Alfred Hospital, Melbourne, Australia; 7 Mayo Clinic Cancer Center, Rochester, MN; and 8 Celgene, Summit, NJ This analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P > .05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalido-mide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials.gov under NCT00056160 [ClinicalTrials.gov] and NCT00424047 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: P. Richardson, S. Jagannath, M. Hussein, J. Berenson, S. Singhal, D. Irwin, S. F. Williams, W. Bensinger, A. Z. Badros, R. Vescio, et al. Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma Blood, July 23, 2009; 114(4): 772 - 778. [Abstract] [Full Text] [PDF] D. Reece, K. W. Song, T. Fu, B. Roland, H. Chang, D. E. Horsman, A. Mansoor, C. Chen, E. Masih-Khan, Y. Trieu, et al. Influence of cytogenetics in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone: adverse effect of deletion 17p13 Blood, July 16, 2009; 114(3): 522 - 525. [Abstract] [Full Text] [PDF]

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