Back to resultsSafety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imexon
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: 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 Criteria: Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
Sites / Locations
- Investigational Site 025
- Investigational Site 008
Outcomes
Primary Outcome Measures
Determine the maximally tolerated dose of imexon in multiple myeloma patients
evaluate the toxicity of imexon
Preliminarily evaluate efficacy in terms of response and progression free survival.
Secondary Outcome Measures
Evaluate biomarker responses.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327249
Brief Title
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
Official Title
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AmpliMed Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma
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 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
imexon
Primary Outcome Measure Information:
Title
Determine the maximally tolerated dose of imexon in multiple myeloma patients
Title
evaluate the toxicity of imexon
Title
Preliminarily evaluate efficacy in terms of response and progression free survival.
Secondary Outcome Measure Information:
Title
Evaluate biomarker responses.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
Facility Information:
Facility Name
Investigational Site 025
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72206
Country
United States
Facility Name
Investigational Site 008
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
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