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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.


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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.

Ruben Niesvizky1, David S. Jayabalan1,2, Paul J. Christos3, Jessica R. Furst1, Tara Naib1, Scott Ely2, Jessica Jalbrzikowski1, Roger N. Pearse1, Faiza Zafar1, Karen Pekle1, April LaRow1, Richard Lent2, Tomer Mark1, Hearn J. Cho1, Tsiporah Shore1, Jeffrey Tepler1, John Harpel1, Michael W. Schuster1, Susan Mathew2, John P. Leonard1, Madhu Mazumdar3, Selina Chen-Kiang2, and Morton Coleman1

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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