Efficacy and safety results with the combination therapy of arsenic trioxide, dexamethasone, and ascorbic acid in multiple myeloma patients: a phase 2 trial.
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| Abstract | BACKGROUND: Single-agent arsenic trioxide has shown promising results in patients with relapsed or refractory multiple myeloma (MM). Because preclinical data suggested greater activity with dexamethasone and ascorbic acid, a phase 2 trial of the combination of arsenic trioxide, dexamethasone, and ascorbic acid in patients with relapsed or refractory MM was conducted. METHODS: Twenty patients in whom no more than two previous therapies had failed were enrolled. The mean age was 62 yr, and 55% of the patients had refractory disease. The regimen consisted of 14- or 15-wk cycles, with the first cycle considered induction, followed by one or two consolidation cycles with a reduced steroid schedule and then a maintenance cycle in responding patients. RESULTS: The overall response rate was 30%, with at least stable disease in 80% of patients. Median progression- free survival was 316 d in all patients and 584 d in those with a response. The regimen was well tolerated, with most adverse events being mild or moderate. CONCLUSIONS: This study showed the clinical efficacy and tolerability of the combination of arsenic trioxide, dexamethasone, and ascorbic acid. Further study is warranted.
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| Authors | Rony M Abou-Jawde, Janice Reed, Megan Kelly, Esteban Walker, Steven Andresen, Rachid Baz, Mary Ann Karam, Mohamad Hussein |
| Journal | Medical oncology (Northwood, London, England) (Med Oncol) Vol. 23 Issue 2 Pg. 263-72 ( 2006) ISSN: 1357-0560 [Print] United States |
| PMID | 16720927 (Publication Type: Clinical Trial, Phase II, Journal Article) |
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