Thalidomide, clarithromycin, lenalidomide and dexamethasone therapy in newly diagnosed, symptomatic multiple myeloma

Abstract

We studied T-BiRD (thalidomide [Thalomid^®], clarithromycin [Biaxin^®], lenalidomide [Revlimid^®] and dexamethasone) in symptomatic, newly diagnosed multiple myeloma. In 28-day cycles, patients received dexamethasone 40 mg/day on days 1, 8, 15, 22, clarithromycin 500 mg twice daily on days 1–28; lenalidomide 25 mg/day on days 1–21; and thalidomide 100 mg/day (50 mg/day on days 1–7 of cycle 1 only) on days 1–28. Twenty-six patients received a median of 6 cycles (range 0–41). Overall response rate (ORR) was 80% for the group and 100% in 11 patients who underwent autologous stem cell transplantation as part of first-line therapy. The 4-year overall survival rate was 74.9%, and the median progression-free survival was 35.6 months. Eight patients discontinued due to regimen toxicity. Grade 3 non hematologic toxicity affected 12 patients (46.2%). T-BiRD is a highly active regimen with potential toxicity limitations.

ClinicalTrials.gov identifier: NCT00538733

Keywords::

• Newly diagnosed multiple myeloma
• thalidomide
• dexamethasone
• lenalidomide
• clarithromycin

Acknowledgements

Medical writing support was provided by Ryan Woodrow and Kate Unsworth of the Investigator-Initiated Research Writing Group (part of the KnowledgePoint360 Group) and was funded by Celgene Corporation. This investigator-initiated study was funded by the Celgene Corporation. This work was supported by a Clinical and Translational Science Center grant (CTSC GRANT UL1-RR024996).

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal.