title: BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma.
abstract: 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.
authors.affiliation: Center of Excellence for Lymphoma and Myeloma, Division of Hematology and Medical Oncology, Department of Medicine, Weill-Cornell Medical College, New York Presbyterian Hospital-Cornell Medical Center, New York, NY 10021, USA. run9001@med.cornell.edu
authors.forename: Ruben
authors.initials: R
authors.lastname: Niesvizky
authors.forename: David S
authors.initials: DS
authors.lastname: Jayabalan
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Christos
authors.forename: Jessica R
authors.initials: JR
authors.lastname: Furst
authors.forename: Tara
authors.initials: T
authors.lastname: Naib
authors.forename: Scott
authors.initials: S
authors.lastname: Ely
authors.forename: Jessica
authors.initials: J
authors.lastname: Jalbrzikowski
authors.forename: Roger N
authors.initials: RN
authors.lastname: Pearse
authors.forename: Faiza
authors.initials: F
authors.lastname: Zafar
authors.forename: Karen
authors.initials: K
authors.lastname: Pekle
authors.forename: April
authors.initials: A
authors.lastname: Larow
authors.forename: Richard
authors.initials: R
authors.lastname: Lent
authors.forename: Tomer
authors.initials: T
authors.lastname: Mark
authors.forename: Hearn J
authors.initials: HJ
authors.lastname: Cho
authors.forename: Tsiporah
authors.initials: T
authors.lastname: Shore
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Tepler
authors.forename: John
authors.initials: J
authors.lastname: Harpel
authors.forename: Michael W
authors.initials: MW
authors.lastname: Schuster
authors.forename: Susan
authors.initials: S
authors.lastname: Mathew
authors.forename: John P
authors.initials: JP
authors.lastname: Leonard
authors.forename: Madhu
authors.initials: M
authors.lastname: Mazumdar
authors.forename: Selina
authors.initials: S
authors.lastname: Chen-Kiang
authors.forename: Morton
authors.initials: M
authors.lastname: Coleman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000145:classification / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide; D017291:Clarithromycin