Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
A Phase II Study Of Genasense In Combination With Thalidomide And Dexamethasone In Relapsed And Refractory Multiple Myeloma
RATIONALE: Thalidomide may slow the growth of cancer cells. Oblimersen may increase the
effectiveness of thalidomide and dexamethasone by making cancer cells more sensitive to the
drugs.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and dexamethasone
with oblimersen in treating patients who have relapsed or refractory multiple myeloma.
OBJECTIVES:
- Determine the clinical efficacy of oblimersen, thalidomide, and dexamethasone, in terms
of complete and partial response rates, in patients with relapsed or refractory multiple
myeloma.
- Determine the time to progression and duration of response in patients treated with this
regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate disease response (clinical outcome) with changes in Bcl-2 levels in patients
treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive induction therapy comprising oblimersen IV continuously on days
1-7, 22-28, and 43-49, oral dexamethasone on days 4-7, 25-28, and 46-49, and oral thalidomide
daily beginning on day 4. Treatment continues in the absence of disease progression or
unacceptable toxicity.
Patients with stable disease after induction therapy receive maintenance therapy comprising
oblimersen IV continuously on days 1-7, oral dexamethasone on days 4-7, and oral thalidomide
daily. Courses repeat every 35 days for up to 2 years in the absence of disease progression
or unacceptable toxicity.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 10-46 patients will be accrued for this study within 10 months.
;
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