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Efficacy and safety results with the combination therapy of arsenic trioxide, dexamethasone, and ascorbic acid in multiple myeloma patients: a phase 2 trial.

AbstractBACKGROUND:
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.
AuthorsRony M Abou-Jawde, Janice Reed, Megan Kelly, Esteban Walker, Steven Andresen, Rachid Baz, Mary Ann Karam, Mohamad Hussein
JournalMedical oncology (Northwood, London, England) (Med Oncol) Vol. 23 Issue 2 Pg. 263-72 ( 2006) ISSN: 1357-0560 [Print] United States
PMID16720927 (Publication Type: Clinical Trial, Phase II, Journal Article)
Chemical References
  • Arsenicals
  • Oxides
  • Vitamins
  • Dexamethasone
  • Ascorbic Acid
  • arsenic trioxide
Topics
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
  • Arsenicals (administration & dosage, adverse effects)
  • Ascorbic Acid (administration & dosage, adverse effects)
  • Dexamethasone (administration & dosage, adverse effects)
  • Disease-Free Survival
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multiple Myeloma (drug therapy, mortality)
  • Oxides (administration & dosage, adverse effects)
  • Recurrence
  • Vitamins (administration & dosage, adverse effects)

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