1. Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial.
- Author
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Reeder, C. B., Reece, D. E., Kukreti, V., Chen, C., Trudel, S., Hentz, J., Noble, B., Pirooz, N. A., Spong, J. E., Piza, J. G., Zepeda, V. H. J., Mikhael, J. R., Leis, J. F., Bergsagel, P. L., Fonseca, R., and Stewart, A. K.
- Subjects
MULTIPLE myeloma ,B cell lymphoma ,CLINICAL trials ,TRANSPLANTATION of organs, tissues, etc. ,DEXAMETHASONE - Abstract
We have studied a three-drug combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) on a 28-day cycle in the treatment of newly diagnosed multiple myeloma (MM) patients to assess response and toxicity. The primary endpoint of response was evaluated after four cycles. Thirty-three newly diagnosed, symptomatic patients with MM received bortezomib 1.3 mg/m(2) intravenously on days 1, 4, 8 and 11, cyclophosphamide 300 mg/m(2) orally on days 1, 8, 15 and 22 and dexamethasone 40 mg orally on days 1-4, 9-12 and 17-20 on a 28-day cycle for four cycles. Responses were rapid with a mean 80% decline in the sentinel monoclonal protein at the end of two cycles. The overall intent to treat response rate (>or= partial response) was 88%, with 61% of very good partial response or better (>or=VGPR) and 39% of complete/near complete response (CR/nCR). For the 28 patients who completed all four cycles of therapy, the CR/nCR rate was 46% and VGPR rate was 71%. All patients undergoing stem cell harvest had a successful collection. Twenty-three patients underwent stem cell transplantation (SCT) and are evaluable through day 100 with CR/nCR documented in 70% and >or=VGPR in 74%. In conclusion, CyBorD produces a rapid and profound response in patients with newly diagnosed MM with manageable toxicity. [ABSTRACT FROM AUTHOR]
- Published
- 2009
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