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

This study has been completed.

Sponsored by: Millennium Pharmaceuticals, Inc.
Information provided by: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00080405
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Phase I

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Multiple Myeloma   

Drug Information available for:   Bortezomib   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:   Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Estimated Enrollment:   40
Study Start Date:   March 2004
Estimated Primary Completion Date:   June 2005 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Male and female adult patients 18 years or older with a diagnosis of relapsed multiple myeloma requiring therapy will be eligible for this study.

Key inclusion criteria include:

Karnofsky Performance Status (KPS) equal to or greater then 70%, normal liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less then 2 x upper limit of normal [ULN], total bilirubin equal to or less then 1.5 x ULN), hemoglobin equal to or greater then 10 g/dL, platelets equal to greater then 50 x 10 to ninth power/L, and absolute neutrophil count (ANC) equal to or greater then 1000/uL; calculated creatinine clearance equal to or greater then 50 mL/min, and normal serum calcium.

Key exclusion criteria include:

Patients with significant cardiac disease, equal to or greater then Grade 2 neuropathy, active hepatitis, HIV infection, secondary malignancy, POEMS syndrome, plasma cell leukemia, or who are transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment will be excluded. Patients taking concurrent medications at entry that may act as inducers or inhibitors of CYP 3A4 are excluded. Patients receiving thalidomide must discontinue that drug at least 2 weeks prior to enrollment. Patients receiving concurrent corticosteroids must have tapered their dose of corticosteroid to to equal to or less then 10 mg/day of prednisone or prednisone equivalent at least 2 weeks prior to enrollment.

  Contacts and Locations

No Contacts or Locations Provided
  More Information


Study ID Numbers:   M34103-058
First Received:   March 30, 2004
Last Updated:   February 7, 2008
ClinicalTrials.gov Identifier:   NCT00080405
Health Authority:   United States: Food and Drug Administration

Keywords provided by Millennium Pharmaceuticals, Inc.:
Relapsed  
Multiple Myeloma  
Pharmacokinetic  
Pharmacodynamic  

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008




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