A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma
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
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
Confirmed response (CR, VGPR, or PR) defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 4 weeks apart.
Ninety percent confidence intervals for the true success proportion will be calculated assuming a binomial distribution.
First 3 months of treatment
United States: Food and Drug Administration
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