Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

Last updated: June 28, 2010
Sponsor: SCRI Development Innovations, LLC
Overall Status: Completed

Phase

2

Condition

Multiple Myeloma

Cancer/tumors

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT00193557
SCRI MM 06
208538
  • Ages > 18
  • All Genders

Study Summary

This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib

Eligibility Criteria

Inclusion

Inclusion Criteria: To be included in this study, you must meet the following criteria:

  • Multiple Myeloma

  • Received no more than 2 previous treatment regimens for multiple Myeloma

  • ECOG performance status 0, 1, or 2

  • Serum creatinine < 2.0mg/dL

  • calculated or measured creatinine clearance > 30ml/minute

  • Measurable or evaluable disease

  • Provide written informed consent prior to receiving protocol therapy.

Exclusion

Exclusion Criteria: You cannot participate in this study if any of the following apply to you:

  • Moderate or severe peripheral neuropathy

  • Other serious medical conditions

  • Other active malignancies

  • history of treatment for other invasive cancers

  • Women who are pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center willdetermine if you meet all of the criteria. If you do not qualify for the trial, studypersonnel will explain the reasons. If you do qualify, study personnel will explain thetrial in detail and answer any questions you may have.

Study Design

Total Participants: 40
Study Start date:
May 01, 2004
Estimated Completion Date:
January 31, 2009

Study Description

Upon determination of eligibility, patients will be receive:

  • Bortezomib

Connect with a study center

  • Florida Cancer Specialists

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37023
    United States

    Site Not Available

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