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R115777 in Treating Patients With Relapsed or Refractory Multiple Myeloma

2014-08-27 03:56:42 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

- 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 months.

Study Design

Primary Purpose: Treatment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Intervention

chemotherapy, tipifarnib

Location

H. Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
United States
33612-9497

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:42-0400

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Medical and Biotech [MESH] Definitions

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.

Drug treatment designed to further diminish the disease toward complete remission following INDUCTION CHEMOTHERAPY. It helps to consolidate the gains during induction chemotherapy and may be followed by MAINTENANCE CHEMOTHERAPY.

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