NCT00047203

Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	alvocidib	Given IV

Timeline

• Start date: 2002-09-01
• Primary completion: 2006-09-01
• First posted: 2003-01-27
• Last updated: 2013-01-16

Locations

1 site across 1 country: United States