NCT00327249

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

Enrollment Period

9 months

First QC Date

May 17, 2006

Last Update Submit

August 7, 2009

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Evaluate biomarker responses.

Interventions

imexonDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Use of corticosteroids for amyloid disorders, or high dose chronic steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational Site 025

Little Rock, Arkansas, 72206, United States

Location

Investigational Site 008

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

4-imino-1,3-diazabicyclo(3.1.0)hexan-2-one

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

October 1, 2005

Primary Completion

July 1, 2006

Study Completion

January 1, 2008

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

US(2)