BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma.
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.
Niesvizky
Ruben
R
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
Jayabalan
David S
DS
Christos
Paul J
PJ
Furst
Jessica R
JR
Naib
Tara
T
Ely
Scott
S
Jalbrzikowski
Jessica
J
Pearse
Roger N
RN
Zafar
Faiza
F
Pekle
Karen
K
Larow
April
A
Lent
Richard
R
Mark
Tomer
T
Cho
Hearn J
HJ
Shore
Tsiporah
T
Tepler
Jeffrey
J
Harpel
John
J
Schuster
Michael W
MW
Mathew
Susan
S
Leonard
John P
JP
Mazumdar
Madhu
M
Chen-Kiang
Selina
S
Coleman
Morton
M
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
D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide; D017291:Clarithromycin