Efficacy and safety results with the combination therapy of arsenic trioxide, dexamethasone, and ascorbic acid in multiple myeloma patients: a phase 2 trial.
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.
Abou-Jawde
Rony M
RM
Department of Hematology and Medical Oncology, Multiple Myeloma Program, Cleveland, OH 44195, USA.
Reed
Janice
J
Kelly
Megan
M
Walker
Esteban
E
Andresen
Steven
S
Baz
Rachid
R
Karam
Mary Ann
MA
Hussein
Mohamad
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000008:administration & dosage / Q000009:adverse effects; D001205:Ascorbic Acid / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D010087:Oxides / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D014815:Vitamins / Q000008:administration & dosage / Q000009:adverse effects
D001152:Arsenicals; D010087:Oxides; D014815:Vitamins; D003907:Dexamethasone; D001205:Ascorbic Acid; D000077237:Arsenic Trioxide