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Blood, 23 July 2009, Vol. 114, No. 4, pp. 772-778. Prepublished online as a Blood First Edition Paper on May 26, 2009; DOI 10.1182/blood-2008-12-196238. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2008-12-196238v1 114/4/772    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 CrossRef Google Scholar Articles by Richardson, P. Articles by Anderson, K. C. PubMed PubMed Citation Articles by Richardson, P. Articles by Anderson, K. C. Related Collections Free Research Articles Lymphoid Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma Paul Richardson1, Sundar Jagannath2, Mohamad Hussein3, James Berenson4, Seema Singhal5, David Irwin6, Stephanie F. Williams7, William Bensinger8, Ashraf Z. Badros9, Robert Vescio10, Laurie Kenvin11, Zhinuan Yu11, Marta Olesnyckyj11, Jerome Zeldis11, Robert Knight11, and Kenneth C. Anderson1 1 Dana-Farber Cancer Institute, Boston, MA; 2 St Vincent's Comprehensive Cancer Center, New York, NY; 3 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; 4 Institute for Myeloma and Bone Cancer Research, West Hollywood, CA; 5 Robert H. Lurie Cancer Center, Chicago, IL; 6 Alta Bates Cancer Center, Berkeley, CA; 7 Hematology-Oncology Associates of Illinois, Chicago; 8 Fred Hutchinson Cancer Research Center, Seattle, WA; 9 Greenebaum Cancer Center, University of Maryland, Baltimore; 10 Cedars-Sinai Medical Center, Los Angeles, CA; and 11 Celgene Corporation, Summit, NJ Lenalidomide plus dexamethasone is effective for the treatment of relapsed and refractory multiple myeloma (MM); however, toxicities from dexamethasone can be dose limiting. We evaluated the efficacy and safety of lenalidomide monotherapy in patients with relapsed and refractory MM. Patients (N = 222) received lenalidomide 30 mg/day once daily (days 1-21 every 28 days) until disease progression or intolerance. Response, progression-free survival (PFS), overall survival (OS), time to progression (TTP), and safety were assessed. Overall, 67% of patients had received 3 or more prior treatment regimens. Partial response or better was reported in 26% of patients, with minimal response 18%. There was no difference between patients who had received 2 or fewer versus 3 or more prior treatment regimens (45% vs 44%, respectively). Median values for TTP, PFS, and OS were 5.2, 4.9, and 23.2 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (60%), thrombocytopenia (39%), and anemia (20%), which proved manageable with dose reduction. Grade 3 or 4 febrile neutropenia occurred in 4% of patients. Lenalidomide monotherapy is active in relapsed and refractory MM with acceptable toxicities. These data support treatment with single-agent lenalidomide, as well as its use in steroid-sparing combination approaches. The study is registered at http://www.clinicaltrials.gov as NCT00065351 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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