Multiple Myeloma Clinical Trial
Official title:
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
Verified date | August 2009 |
Source | AmpliMed Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 0 |
Est. completion date | January 2008 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Investigational Site 008 | Houston | Texas |
United States | Investigational Site 025 | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
AmpliMed Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the maximally tolerated dose of imexon in multiple myeloma patients | |||
Primary | evaluate the toxicity of imexon | |||
Primary | Preliminarily evaluate efficacy in terms of response and progression free survival. | |||
Secondary | Evaluate biomarker responses. |
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