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

Phase 1

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00327249
• Lead Sponsor: AmpliMed Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-05-17
• Study First Submitted QC: 2006-05-17
• Study First Posted: 2006-05-18
• Primary Completion: 2006-07
• Study Completion: 2008-01
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-07
• Last Update Posted: 2009-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluate biomarker responses.

Trial Locations

Locations (2)

Investigational Site 025; 🇺🇸 Little Rock, Arkansas, United States

Investigational Site 008; 🇺🇸 Houston, Texas, United States