Multiple Myeloma Clinical Trial
Official title:
Phase II Evaluation of FTI (R115777) (NSC 702818) in Treatment of Advanced Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have
relapsed or refractory multiple myeloma.
OBJECTIVES: I. Determine the rate of objective response and disease stabilization in
patients with relapsed or refractory multiple myeloma treated with R115777. II. Determine
whether the degree of inhibition of FTase activity and farnesylation of lamin-B, H-, K-, and
N-RAS in peripheral blood mononuclear cells and tumor tissue correlates with tumor response
in patients treated with this regimen. III. Determine whether the presence of activating RAS
mutations in myeloma cells predicts treatment response in patients treated with this
regimen. IV. Correlate R115777 plasma levels and RAS mutation status with tumor response in
patients treated with this regimen.
OUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity. Patients are followed
for at least 30 days.
PROJECTED ACCRUAL: Approximately 12-42 patients will be accrued for this study within 25
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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