Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma.
| Title: | Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma. |
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| Authors: | Gay F; Division of Hematology, Department of Internal Medicine, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA.; Rajkumar SV; 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; Stewart AK; Niesvizky R |
| Source: | American journal of hematology [Am J Hematol] 2010 Sep; Vol. 85 (9), pp. 664-9. |
| Publication Type: | Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: Wiley-Blackwell Country of Publication: United States NLM ID: 7610369 Publication Model: Print Cited Medium: Internet ISSN: 1096-8652 (Electronic) Linking ISSN: 03618609 NLM ISO Abbreviation: Am J Hematol Subsets: MEDLINE |
| Imprint Name(s): | Publication: New York Ny : Wiley-Blackwell; Original Publication: New York, Liss. |
| MeSH Terms: | Antineoplastic Combined Chemotherapy Protocols/*administration & dosage ; Multiple Myeloma/*therapy; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Clarithromycin/administration & dosage ; Clarithromycin/adverse effects ; Dexamethasone/administration & dosage ; Dexamethasone/adverse effects ; Multiple Myeloma/mortality ; Thalidomide/administration & dosage ; Thalidomide/adverse effects ; Thalidomide/analogs & derivatives ; Thrombocytopenia/chemically induced ; Thrombocytopenia/mortality ; Adult ; Aged ; Aged, 80 and over ; Case-Control Studies ; Disease-Free Survival ; Double-Blind Method ; Female ; Humans ; Lenalidomide ; Male ; Middle Aged ; Survival Rate |
| 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.; (© 2010 Wiley-Liss, Inc.) |
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| Grant Information: | P01 CA062242 United States CA NCI NIH HHS; R01 CA107476 United States CA NCI NIH HHS; CA107476 United States CA NCI NIH HHS; CA62242 United States CA NCI NIH HHS |
| Substance Nomenclature: | 4Z8R6ORS6L (Thalidomide); 7S5I7G3JQL (Dexamethasone); F0P408N6V4 (Lenalidomide); H1250JIK0A (Clarithromycin) |
| Entry Date(s): | Date Created: 20100721 Date Completed: 20101001 Latest Revision: 20220318 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC3956597 |
| DOI: | 10.1002/ajh.21777 |
| PMID: | 20645430 |
| Database: | MEDLINE |
Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't