Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma
2 other identifiers
interventional
40
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 multiple-myeloma
Started May 2004
Typical duration for phase_2 multiple-myeloma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJune 29, 2010
January 1, 2009
2 years
September 12, 2005
June 28, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
objective response rate
Secondary Outcomes (3)
progression-free survival
overall survival
Safety
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related Publications (1)
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.
PMID: 18543319RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
May 1, 2004
Primary Completion
May 1, 2006
Study Completion
January 1, 2009
Last Updated
June 29, 2010
Record last verified: 2009-01