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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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Submitted May 16, 2007
Accepted October 28, 2007
BiRD (Biaxin®[clarithromycin]/Revlimid®[lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma
Ruben Niesvizky*, David S. Jayabalan, Paul J. Christos, Jessica R. Furst, Tara Naib, Scott Ely, Jessica Jalbrzikowski, Roger N. Pearse, Faiza Zafar, Karen Pekle, April LaRow, Richard Lent, Tomer Mark, Hearn J. Cho, Tsiporah Shore, Jeffrey Tepler, John Harpel, Michael W. Schuster, Susan Mathew, John P. Leonard, Madhu Mazumdar, Selina Chen-Kiang, and Morton Coleman
Dept. of Medicine, Division of Hematology & Medical Oncology, Center of Excellence for Lymphoma and Myeloma, New York, NY, United States
Department of Pathology, Weill-Cornell Medical College, New York Presbyterian Hospital-Cornell Medical Center, New York, NY, United States
Dept. of Public Health, Div. of Biostatistics & Epidemiology, Weill-Cornell Medical College, New York Presbyterian Hospital-Cornell Medical Center, New York, NY, United States
* Corresponding author; email: run9001{at}med.cornell.edu.
The aim of this trial was to determine 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 1-21. In cycle 1, patients received dexamethasone on 3 consecutive days, and lenalidomide was begun on day 3 for pharmacokinetic studies. Objective response was defined by standard criteria (i.e. decrease in serum monoclonal protein [M-protein] by 50%, and a decrease in urine M-protein by 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 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 transplantation received continued therapy (complete response 37%, very good partial response 33%). The major toxicities 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.

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