Status:
COMPLETED
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
Lead Sponsor:
AmpliMed Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patien...
Eligibility Criteria
Inclusion
- Advanced myeloma, with measurable disease as defined in the protocol.
- Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
- Able to perform the activities of daily living.
- Off prior therapy for at least 2-4 weeks depending on the drug.
- Blood counts and blood chemistries in or near normal range.
- If female, neither pregnant nor nursing.
- Willing to use contraceptives to prevent pregnancy.
- No other serious illnesses.
- No other active malignancy.
- No serious infections.
- No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
- Prior radiation is permitted.
Exclusion
- Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00327249
Start Date
October 1 2005
End Date
January 1 2008
Last Update
August 11 2009
Active Locations (2)
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1
Investigational Site 025
Little Rock, Arkansas, United States, 72206
2
Investigational Site 008
Houston, Texas, United States, 77030