title: Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma.
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.
authors.affiliation: Division of Hematology, Department of Internal Medicine, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA.
authors.forename: Francesca
authors.initials: F
authors.lastname: Gay
authors.forename: S Vincent
authors.initials: SV
authors.lastname: Rajkumar
authors.forename: Morton
authors.initials: M
authors.lastname: Coleman
authors.forename: Shaji
authors.initials: S
authors.lastname: Kumar
authors.forename: Tomer
authors.initials: T
authors.lastname: Mark
authors.forename: Angela
authors.initials: A
authors.lastname: Dispenzieri
authors.forename: Roger
authors.initials: R
authors.lastname: Pearse
authors.forename: Morie A
authors.initials: MA
authors.lastname: Gertz
authors.forename: John
authors.initials: J
authors.lastname: Leonard
authors.forename: Martha Q
authors.initials: MQ
authors.lastname: Lacy
authors.forename: Selina
authors.initials: S
authors.lastname: Chen-Kiang
authors.forename: Vivek
authors.initials: V
authors.lastname: Roy
authors.forename: David S
authors.initials: DS
authors.lastname: Jayabalan
authors.forename: John A
authors.initials: JA
authors.lastname: Lust
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
authors.forename: Rafael
authors.initials: R
authors.lastname: Fonseca
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kyle
authors.forename: Philip R
authors.initials: PR
authors.lastname: Greipp
authors.forename: A Keith
authors.initials: AK
authors.lastname: Stewart
authors.forename: Ruben
authors.initials: R
authors.lastname: Niesvizky
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016022:Case-Control Studies; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D013921:Thrombocytopenia / Q000139:chemically induced / Q000401:mortality
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide; D017291:Clarithromycin