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Completed

NCT Number: NCT00193557

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida Cancer Specialists, Fort Myers, Florida, United States

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About this study

Upon determination of eligibility, patients will be receive:

  • Bortezomib

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bortezomib

Drug

Primary outcomes

  1. objective response rate

Secondary outcomes

  1. progression-free survival

  2. overall survival

  3. Safety

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Jun 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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