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Blood, 1 February 2008, Vol. 111, No. 3, pp. 1101-1109. Prepublished online as a Blood First Edition Paper on November 7, 2007; DOI 10.1182/blood-2007-05-090258.
CLINICAL TRIALS AND OBSERVATIONS BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma.1 Center of Excellence for Lymphoma and Myeloma, Division of Hematology and Medical Oncology, Department of Medicine 2 Department of Pathology, and 3 Division of Biostatistics and Epidemiology, Department of Public Health, Weill-Cornell Medical College, New York Presbyterian Hospital-Cornell Medical Center, New York, NY This trial determined the safety and efficacy of the combination regimen clarithromycin (Biaxin), lenalidomide (Revlimid), and dexamethasone (BiRD) as first-line therapy for multiple myeloma. Patients received BiRD in 28-day cycles. Dexamethasone (40 mg) was given orally once weekly, clarithromycin (500 mg) was given orally twice daily, and lenalidomide (25 mg) was given orally daily on days 1 to 21. Objective response was defined by standard criteria (ie, decrease in serum monoclonal protein [M-protein] by at least 50%, and a decrease in urine M-protein by at least 90%). Of the 72 patients enrolled, 65 had an objective response (90.3%). A combined stringent and conventional complete response rate of 38.9% was achieved, and 73.6% of the patients achieved at least a 90% decrease in M-protein levels. This regimen did not interfere with hematopoietic stem-cell harvest. Fifty-two patients who did not go on to receive transplants received continued therapy (complete response, 37%; very good partial response, 33%). The major adverse events were thromboembolic events, corticosteroid-related morbidity, and cytopenias. BiRD is an effective regimen with manageable side effects in the treatment of symptomatic, newly diagnosed multiple myeloma. This trial was registered at www.clinicaltrials.gov as #NCT00151203 [ClinicalTrials.gov] .
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| Copyright © 2008 by American Society of Hematology Online ISSN: 1528-0020 | |||||||||