Refractory Multiple Myeloma Clinical Trial
Official title:
A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with relapsed or refractory multiple myeloma
treated with flavopiridol.
II. Determine the disease-free survival and overall survival of patients treated with this
drug.
III. Correlate disease response with t(11;14)(q13;q32) rearrangement, p16 methylation
status, and BCRP expression in patients treated with this drug.
IV. Correlate disease response and drug treatment with cell cycle status and effects on
apoptosis and apoptosis regulatory proteins in these patients.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for
up to 12 months in the absence of disease progression or unacceptable toxicity. After 12
months, patients achieving at least a partial response may continue treatment in the absence
of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 1 year.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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