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Blood, 15 November 2006, Vol. 108, No. 10, pp. 3458-3464. Prepublished online as a Blood First Edition Paper on July 18, 2006; DOI 10.1182/blood-2006-04-015909. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2006-04-015909v1 blood-2006-04-015909v2 108/10/3458    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 Richardson, P. G. Articles by Anderson, K. C. Search for Related Content PubMed PubMed Citation Articles by Richardson, P. G. Articles by Anderson, K. C. Related Collections Clinical Trials and Observations Neoplasia Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  NEOPLASIA A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma Paul G. Richardson, Emily Blood, Constantine S. Mitsiades, Sundar Jagannath, Steven R. Zeldenrust, Melissa Alsina, Robert L. Schlossman, S. Vincent Rajkumar, K. Raman Desikan, Teru Hideshima, Nikhil C. Munshi, Kathleen Kelly-Colson, Deborah Doss, Mary L. McKenney, Svetlana Gorelik, Diane Warren, Andrea Freeman, Rebecca Rich, Anfang Wu, Marta Olesnyckyj, Kenton Wride, William S. Dalton, Jerome Zeldis, Robert Knight, Edie Weller, and Kenneth C. Anderson From the Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; St Vincent's Comprehensive Cancer Center, New York, NY; the Mayo Clinic, Rochester, MN; H. Lee Moffitt Cancer Center, Tampa, FL; and Celgene, Summit, NJ. This multicenter, open-label, randomized phase 2 study evaluated 2 dose regimens of lenalidomide for relapsed, refractory myeloma. Seventy patients were randomized to receive either 30 mg once-daily or 15 mg twice-daily oral lenalidomide for 21 days of every 28-day cycle. Patients with progressive or stable disease after 2 cycles received dexamethasone. Analysis of the first 70 patients showed increased grade 3/4 myelo-suppression in patients receiving 15 mg twice daily (41% versus 13%, P = .03). An additional 32 patients received 30 mg once daily. Responses were evaluated according to European Group for Blood and Marrow Transplantation (EBMT) criteria. Overall response rate (complete, partial, or minor) to lenalidomide alone was 25% (24% for once-daily and 29% for twice-daily lenalidomide). Median overall survival in 30-mg once-daily and twice-daily groups was 28 and 27 months, respectively. Median progression-free survival was 7.7 months on once-daily versus 3.9 months on twice-daily lenalidomide (P = .2). Dexamethasone was added in 68 patients and 29% responded. Time to first occurrence of clinically significant grade 3/4 myelosuppression was shorter in the twice-daily group (1.8 vs 5.5 months, P = .05). Significant peripheral neuropathy and deep vein thrombosis each occurred in only 3%. Lenalidomide is active and well tolerated in relapsed, refractory myeloma, with the 30-mg once-daily regimen providing the basis for future studies as monotherapy and with dexamethasone. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: When "the same" is really "different" Sagar Lonial Blood 2006 108: 3233-3234. [Full Text] [PDF] This article has been cited by other articles: A. Ferrajoli, B.-N. Lee, E. J. Schlette, S. M. O'Brien, H. Gao, S. Wen, W. G. Wierda, Z. Estrov, S. Faderl, E. N. Cohen, et al. 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Bensinger Stem-Cell Transplantation for Multiple Myeloma in the Era of Novel Drugs J. Clin. Oncol., January 20, 2008; 26(3): 480 - 492. [Abstract] [Full Text] [PDF] H. A. Fine, L. Kim, P. S. Albert, J. P. Duic, H. Ma, W. Zhang, T. Tohnya, W. D. Figg, and C. Royce A Phase I Trial of Lenalidomide in Patients with Recurrent Primary Central Nervous System Tumors Clin. Cancer Res., December 1, 2007; 13(23): 7101 - 7106. [Abstract] [Full Text] [PDF] N. Chen, H. Lau, L. Kong, G. Kumar, J. B. Zeldis, R. Knight, and O. L. Laskin Pharmacokinetics of Lenalidomide in Subjects With Various Degrees of Renal Impairment and in Subjects on Hemodialysis J. Clin. Pharmacol., December 1, 2007; 47(12): 1466 - 1475. [Abstract] [Full Text] [PDF] M. Dimopoulos, A. Spencer, M. Attal, H. M. Prince, J.-L. Harousseau, A. Dmoszynska, J. S. Miguel, A. Hellmann, T. Facon, R. Foa, et al. Lenalidomide plus Dexamethasone for Relapsed or Refractory Multiple Myeloma N. Engl. J. 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