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

Francesca Gay, S Vincent Rajkumar, Morton Coleman, Shaji K Kumar, Tomer Mark, Angela Dispenzieri, Roger Pearse, Morie Gertz, John Leonard, Martha Lacy, Selina Chen-Kiang, Vivek Roy, David S. Jayabalan, John A. Lust, Thomas Elmer Witzig, Rafael Fonseca, Robert A. Kyle, Philip R. Greipp, Alexander Keith Stewart, Ruben Niesvizky

Research output: Contribution to journalArticle

41 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)664-669
Number of pages6
JournalAmerican Journal of Hematology
Volume85
Issue number9
DOIs
StatePublished - 2010

Fingerprint

Clarithromycin
Dexamethasone
Birds
Intention to Treat Analysis
Thrombocytopenia
Disease-Free Survival
lenalidomide
Transplants
Infection

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)

Cite this

Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma. / Gay, Francesca; Rajkumar, S Vincent; Coleman, Morton; Kumar, Shaji K; Mark, Tomer; Dispenzieri, Angela; Pearse, Roger; Gertz, Morie; Leonard, John; Lacy, Martha; Chen-Kiang, Selina; Roy, Vivek; Jayabalan, David S.; Lust, John A.; Witzig, Thomas Elmer; Fonseca, Rafael; Kyle, Robert A.; Greipp, Philip R.; Stewart, Alexander Keith; Niesvizky, Ruben.

In: American Journal of Hematology, Vol. 85, No. 9, 2010, p. 664-669.

Research output: Contribution to journalArticle

Gay, Francesca ; Rajkumar, S Vincent ; Coleman, Morton ; Kumar, Shaji K ; Mark, Tomer ; Dispenzieri, Angela ; Pearse, Roger ; Gertz, Morie ; Leonard, John ; Lacy, Martha ; Chen-Kiang, Selina ; Roy, Vivek ; Jayabalan, David S. ; Lust, John A. ; Witzig, Thomas Elmer ; Fonseca, Rafael ; Kyle, Robert A. ; Greipp, Philip R. ; Stewart, Alexander Keith ; Niesvizky, Ruben. / Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma. In: American Journal of Hematology. 2010 ; Vol. 85, No. 9. pp. 664-669.
@article{f40cebcc15174f5da189ce516ada2deb,
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.",
author = "Francesca Gay and Rajkumar, {S Vincent} and Morton Coleman and Kumar, {Shaji K} and Tomer Mark and Angela Dispenzieri and Roger Pearse and Morie Gertz and John Leonard and Martha Lacy and Selina Chen-Kiang and Vivek Roy and Jayabalan, {David S.} and Lust, {John A.} and Witzig, {Thomas Elmer} and Rafael Fonseca and Kyle, {Robert A.} and Greipp, {Philip R.} and Stewart, {Alexander Keith} and Ruben Niesvizky",
year = "2010",
doi = "10.1002/ajh.21777",
language = "English (US)",
volume = "85",
pages = "664--669",
journal = "American Journal of Hematology",
issn = "0361-8609",
publisher = "Wiley-Liss Inc.",
number = "9",

}

TY - JOUR

T1 - Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma

AU - Gay, Francesca

AU - Rajkumar, S Vincent

AU - Coleman, Morton

AU - Kumar, Shaji K

AU - Mark, Tomer

AU - Dispenzieri, Angela

AU - Pearse, Roger

AU - Gertz, Morie

AU - Leonard, John

AU - Lacy, Martha

AU - Chen-Kiang, Selina

AU - Roy, Vivek

AU - Jayabalan, David S.

AU - Lust, John A.

AU - Witzig, Thomas Elmer

AU - Fonseca, Rafael

AU - Kyle, Robert A.

AU - Greipp, Philip R.

AU - Stewart, Alexander Keith

AU - Niesvizky, Ruben

PY - 2010

Y1 - 2010

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=77956457402&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77956457402&partnerID=8YFLogxK

U2 - 10.1002/ajh.21777

DO - 10.1002/ajh.21777

M3 - Article

C2 - 20645430

AN - SCOPUS:77956457402

VL - 85

SP - 664

EP - 669

JO - American Journal of Hematology

JF - American Journal of Hematology

SN - 0361-8609

IS - 9

ER -