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

This study has been completed.
Sponsor:
Information provided by:
AmpliMed Corporation
ClinicalTrials.gov Identifier:
NCT00327249
First received: May 17, 2006
Last updated: August 7, 2009
Last verified: August 2009
  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 1
Phase 2

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

Resource links provided by NLM:


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: Evan Hersh, AmpliMed
ClinicalTrials.gov Identifier: NCT00327249     History of Changes
Other Study ID Numbers: AMP-007
Study First Received: May 17, 2006
Last Updated: August 7, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014