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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AmpliMed Corporation

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.