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

This study has been completed.
Information provided by:
Millennium Pharmaceuticals, Inc. Identifier:
First received: March 30, 2004
Last updated: March 26, 2009
Last verified: March 2009
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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

Resource links provided by NLM:

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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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No Contacts or Locations Provided
  More Information Identifier: NCT00080405     History of Changes
Other Study ID Numbers: M34103-058
Study First Received: March 30, 2004
Last Updated: March 26, 2009

Keywords provided by Millennium Pharmaceuticals, Inc.:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents processed this record on May 22, 2017