Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT00327249

Run by

AmpliMed Corporation

Starts

2005-10-01

Expected to finish

2008-01-01

Last updated by the study team

2009-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Use of corticosteroids for amyloid disorders, or high dose chronic steroids.

Where it is running

• Investigational Site 025 — Little Rock, Arkansas, United States
• Investigational Site 008 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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