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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximally tolerated dose of imexon in multiple myeloma patients

Authority:

United States: Food and Drug Administration

Study ID:

AMP-007

NCT ID:

NCT00327249

Start Date:

October 2005

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

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