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

AmpliMed

Status and phase

Completed

Phase 2

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: imexon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327249

AMP-007

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.