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

June 28, 2010 updated by: SCRI Development Innovations, LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upon determination of eligibility, patients will be receive:

  • Bortezomib

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
    • Tennessee
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
objective response rate

Secondary Outcome Measures

Outcome Measure
Safety
overall survival
progression-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Millennium Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

June 29, 2010

Last Update Submitted That Met QC Criteria

June 28, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI MM 06
  • 208538

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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