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Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma.

TitleClarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma.
Publication TypeJournal Article
Year of Publication2010
AuthorsGay F, S Rajkumar V, Coleman M, Kumar S, Mark T, Dispenzieri A, Pearse R, Gertz MA, Leonard J, Lacy MQ, Chen-Kiang S, Roy V, Jayabalan DS, Lust JA, Witzig TE, Fonseca R, Kyle RA, Greipp PR, A Stewart K, Niesvizky R
JournalAm J Hematol
Volume85
Issue9
Pagination664-9
Date Published2010 Sep
ISSN1096-8652
KeywordsAdult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Case-Control Studies, Clarithromycin, Dexamethasone, Disease-Free Survival, Double-Blind Method, Female, Humans, Male, Middle Aged, Multiple Myeloma, Survival Rate, Thalidomide, Thrombocytopenia
Abstract

The objective of this case-matched study was to compare the efficacy and toxicity of the addition of clarithromycin (Biaxin) to lenalidomide/low-dose dexamethasone (BiRd) vs. lenalidomide/low-dose dexamethasone (Rd) for newly diagnosed myeloma. Data from 72 patients treated at the New York Presbyterian Hospital-Cornell Medical Center were retrospectively compared with an equal number of matched pair mates selected among patients seen at the Mayo Clinic who received Rd. Case matching was blinded and was performed according to age, gender, and transplant status. On intention-to-treat analysis, complete response (45.8% vs. 13.9%, P < 0.001) and very-good-partial-response or better (73.6% vs. 33.3%, P < 0.001) were significantly higher with BiRd. Time-to-progression (median 48.3 vs. 27.5 months, P = 0.071), and progression-free survival (median 48.3 vs. 27.5 months, P = 0.044) were higher with BiRd. There was a trend toward better OS with BiRd (3-year OS: 89.7% vs. 73.0%, P = 0.170). Main grade 3-4 toxicities of BiRd were hematological, in particular thrombocytopenia (23.6% vs. 8.3%, P = 0.012). Infections (16.7% vs. 9.7%, P = 0.218) and dermatological toxicity (12.5% vs. 4.2%, P = 0.129) were higher with Rd. Results of this case-matched analysis suggest that there is significant additive value when clarithromycin is added to Rd. Randomized phase III trials are needed to confirm these results.

DOI10.1002/ajh.21777
Alternate JournalAm. J. Hematol.
PubMed ID20645430
PubMed Central IDPMC3956597
Grant ListP01 CA062242 / CA / NCI NIH HHS / United States
R01 CA107476 / CA / NCI NIH HHS / United States
CA107476 / CA / NCI NIH HHS / United States
CA62242 / CA / NCI NIH HHS / United States