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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Mayo Clinic
Rochester, Minnesota, United States
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.
Time frame: First 3 months of treatment
Overall survival time
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 1 year
Time to disease progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to documentation of disease progression, assessed up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.