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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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

Upon determination of eligibility, patients will be receive:

- Bortezomib

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

January 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Florida Cancer SpecialistsFort Myers, Florida  33901
Tennessee Oncology, PLLCClarksville, Tennessee  37043