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Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

2014-08-27 03:54:30 | BioPortfolio

Summary

The purpose of this study is to characterize the clinical pharmacokinetic and pharmacodynamic profiles of the 2 doses of VELCADE (bortezomib) for Injection. Patients who volunteer to participate in the pharmacogenetic portion of the study, an additional blood sample will be collected before the Cycle 1 Day 1 dose of bortezomib to assess the genotype of drug metabolizing enzymes.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

Bortezomib

Status

Completed

Source

Millennium Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:30-0400

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Medical and Biotech [MESH] Definitions

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.

An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.

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.

An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.

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