Back to resultsWeekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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.
Sites / Locations
- Florida Cancer Specialists
- Tennessee Oncology, PLLC
Outcomes
Primary Outcome Measures
objective response rate
Secondary Outcome Measures
progression-free survival
overall survival
Safety
Full Information
NCT ID
NCT00193557
First Posted
September 12, 2005
Last Updated
June 28, 2010
Sponsor
SCRI Development Innovations, LLC
Collaborators
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00193557
Brief Title
Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
Official Title
Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Millennium Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief 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
Detailed Description
Upon determination of eligibility, patients will be receive:
Bortezomib
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Primary Outcome Measure Information:
Title
objective response rate
Secondary Outcome Measure Information:
Title
progression-free survival
Title
overall survival
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18543319
Citation
Hainsworth JD, Spigel DR, Barton J, Farley C, Schreeder M, Hon J, Greco FA. Weekly treatment with bortezomib for patients with recurrent or refractory multiple myeloma: a phase 2 trial of the Minnie Pearl Cancer Research Network. Cancer. 2008 Aug 15;113(4):765-71. doi: 10.1002/cncr.23606.
Results Reference
result
Learn more about this trial
Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
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