BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma

• Published in: Blood 2008-02, Vol.111 (3), p.1101-1109
• Main Authors: Niesvizky, Ruben, Jayabalan, David S., Christos, Paul J., Furst, Jessica R., Naib, Tara, Ely, Scott, Jalbrzikowski, Jessica, Pearse, Roger N., Zafar, Faiza, Pekle, Karen, LaRow, April, Lent, Richard, Mark, Tomer, Cho, Hearn J., Shore, Tsiporah, Tepler, Jeffrey, Harpel, John, Schuster, Michael W., Mathew, Susan, Leonard, John P., Mazumdar, Madhu, Chen-Kiang, Selina, Coleman, Morton
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Clarithromycin - administration & dosage; Clarithromycin - adverse effects; Clarithromycin - therapeutic use; Dexamethasone - administration & dosage; Dexamethasone - adverse effects; Dexamethasone - therapeutic use; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Hematologic and hematopoietic diseases; Humans; Immunodeficiencies. Immunoglobulinopathies; Immunoglobulinopathies; Immunopathology; Lenalidomide; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Male; Medical sciences; Middle Aged; Multiple Myeloma - classification; Multiple Myeloma - drug therapy; Multiple Myeloma - pathology; Neoplasm Staging; Thalidomide - administration & dosage; Thalidomide - adverse effects; Thalidomide - analogs & derivatives; Thalidomide - therapeutic use; Time Factors
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2007-05-090258

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.