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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 13, 2006July 18, 2006; DOI 10.1182/blood-2006-04-015909. This Article 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 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 Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted April 13, 2006 Accepted May 22, 2006 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 V Rajkumar, K R Desikan, Teru Hideshima, Nikhil C Munshi, Kathleen Kelly-Colson, Deborah Doss, Mary L McKenney, Svetlana Gorelik, Diane Warren, Andrea Freeman, Rebecca Rich, A. Wu, M Olesnyckyj, K Wride, William S Dalton, Jerome Zeldis, Robert Knight, Edie Weller, and Kenneth C Anderson Dana Farber Cancer Institute, Boston, MA Dana-Farber Cancer Institute, Harvard Med. School St Vincent's Comprehensive Cancer Center, NY Mayo Clinic, Rochester, MN H.Lee Moffitt Cancer Center, Tampa, FL St Vincent's Comprehensive Cancer Center, NY, NY; Dana-Farber Cancer Institute, Boston, MA Celgene Corp. Summit, NJ H. Lee Moffitt Cancer Center * Corresponding author; email: paul_richardson{at}dfci.harvard.edu. This multi-center, 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 of every 28-day cycle. Patients with progressive or stable disease after two cycles received dexamethasone. Analysis of the first 70 patients showed increased grade 3-4 myelosuppression in patients receiving 15 mg twice-daily (41% versus 13%, p=0.03). An additional 32 patients received 30 mg once- daily. Responses were evaluated according to EBMT criteria. Overall response rate (complete, partial or minor) to lenalidomide alone was 25% (24% for once-daily and 28% for twice-daily lenalidomide, respectively). Median overall survival in 30 mg once-daily and twice- daily groups was 31 and 27 months. Median progression- free survival was 7.7 months on once-daily vs 3.9 months on twice-daily lenalidomide (p=0.2). Dexamethasone was added in 68 patients and 29% responded. Time to first occurrence of grade 3-4 myelosuppression was shorter in the twice-daily group (1.8 vs 5.5 months, p=0.05). Significant peripheral neuropathy and deep vein thrombosis each occurred in only 3%. Lenalidomide is active and well tolerated in relapsed, refractory myeloma. The 30 mg once-daily regimen provides 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. 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Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial Blood, February 15, 2008; 111(4): 1805 - 1810. [Abstract] [Full Text] [PDF] L. E. Perez, N. Parquet, K. Shain, R. Nimmanapalli, M. Alsina, C. Anasetti, and W. Dalton Bone Marrow Stroma Confers Resistance to Apo2 Ligand/TRAIL in Multiple Myeloma in Part by Regulating c-FLIP J. Immunol., February 1, 2008; 180(3): 1545 - 1555. [Abstract] [Full Text] [PDF] W. 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. 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