Phase II Study of Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Patients With Previously Untreated High-Risk or Relapsed or Refractory Multiple Myeloma
- Determine the response rate in patients with previously untreated high-risk or relapsed
or refractory multiple myeloma (MM) treated with arsenic trioxide, ascorbic acid,
dexamethasone, and thalidomide.
- Determine the safety of this regimen in these patients.
- Determine the duration of response, progression-free survival, and overall survival of
patients with previously untreated high-risk MM treated with this regimen.
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive arsenic trioxide IV over 1-4 hours and ascorbic
acid IV over 15-30 minutes on days 1-5 in week 1 and then twice weekly in weeks 2-12;
oral dexamethasone on days 1-4, 11-14, 29-32, 39-42, 57-60, and 67-70 (weeks 1, 2, 5,
6, 9, and 10); and oral thalidomide once daily in weeks 1-12.
- Consolidation therapy: Beginning 4 weeks after completion of induction therapy,
patients receive arsenic trioxide and ascorbic acid as in induction therapy; oral
dexamethasone on days 1-4, 29-32, and 57-60 (weeks 1, 5, and 9); and oral thalidomide
once daily in weeks 1-12.
- Maintenance therapy: Beginning 4 weeks after completion of consolidation therapy,
patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 15-30
minutes on days 1, 8, 15, and 22. Treatment with arsenic trioxide and ascorbic acid
repeats every 90 days (every 12 weeks). Patients also receive oral dexamethasone on
days 1-4. Treatment with dexamethasone repeats every 28 days. Patients receive oral
thalidomide once daily. Maintenance therapy continues in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 6
PROJECTED ACCRUAL: A total of 33-68 patients (15-34 with previously untreated high-risk
multiple myeloma [MM] and 18-34 with relapsed or refractory MM) will be accrued for this
Primary Purpose: Treatment
Mohamad A. Hussein, MD
The Cleveland Clinic
United States: Federal Government
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