A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma

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.