NCT00327249CompletedPhase 1
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AmpliMed Corporation
- Locations
- 2
- Primary Endpoint
- Determine the maximally tolerated dose of imexon in multiple myeloma patients
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- Evaluate biomarker responses.
Investigators
Study Sites (2)
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