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

This study has been completed.

First Received: May 17, 2006 Last Updated: April 4, 2008 History of Changes

Sponsored by:	AmpliMed Corporation
Information provided by:	AmpliMed Corporation
ClinicalTrials.gov Identifier:	NCT00327249

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Drug: imexon	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma

Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:

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:

Evaluate biomarker responses.

Study Start Date:	October 2005
Study Completion Date:	January 2008
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327249

Locations

United States, Arkansas
Investigational Site 025
Little Rock, Arkansas, United States, 72206
United States, Texas
Investigational Site 008
Houston, Texas, United States, 77030

Sponsors and Collaborators

AmpliMed Corporation

More Information

No publications provided

Responsible Party:	AmpliMed ( Evan Hersh )
Study ID Numbers:	AMP-007
Study First Received:	May 17, 2006
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00327249 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases

Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009