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NCT Number: NCT00327249

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

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site 025, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

imexon

Drug

Primary outcomes

  1. Determine the maximally tolerated dose of imexon in multiple myeloma patients

  2. evaluate the toxicity of imexon

  3. Preliminarily evaluate efficacy in terms of response and progression free survival.

Secondary outcomes

  1. Evaluate biomarker responses.

Sponsors and collaborators

Lead sponsor

AmpliMed Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
May 18, 2006
Registry last updated
Aug 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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