Phase II Evaluation of FTI (R115777) (NSC 702818) in Treatment of Advanced Multiple Myeloma
- Determine the objective response rate and disease-stabilization rate in patients with
relapsed or refractory multiple myeloma treated with R115777.
- Determine whether the degree of inhibition of FTase activity and farnesylation of
lamin-B, H-RAS, K-RAS, and N-RAS in peripheral blood mononuclear cells (PBMC) and tumor
tissue correlates with tumor response in patients treated with this drug.
- Determine whether the presence of activating RAS mutations in myeloma cells correlates
with disease response in patients treated with this drug.
- Correlate R115777 plasma levels, degree of farnesylation inhibition in PBMC and tumor
tissue, and RAS mutation status with tumor response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 4 weeks in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 12-42 patients will be accrued for this study within 8-25
Primary Purpose: Treatment
Melissa Alsina, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|