View Clinical Trial (Medical Research Study)
Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis
| City: |
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Powell |
| State: |
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Tennessee |
| Zip Code: |
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37849 |
| Conditions: |
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Multiple Myeloma and Plasma Cell Neoplasm |
| Purpose: |
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RATIONALE: Antibodies, such as human immune globulin, can block the growth of abnormal cells
in different ways. Some block the ability of abnormal cells to grow and spread. Others find
abnormal cells and help kill them or carry cell-killing substances to them. Giving human
immune globulin may be effective in treating patients with primary amyloidosis that is
causing heart dysfunction.
PURPOSE: This phase I/II trial is studying the side effects and best dose of human immune
globulin and to see how well it works in treating patients with primary amyloidosis that is
causing heart dysfunction.
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| Study Summary: |
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OBJECTIVES:
- Establish the maximum tolerated dose of human immune globulin intravenous (IGIV) given
weekly for the first 3 months and then bi-weekly for 9 additional months in patients
with cardiac-associated primary amyloidosis.
- Determine the safety, pharmakinetics, and therapeutic efficacy as evidenced by titers
of serum fibril-reactive IgG antibodies pre- and post-IGIV infusions.
- Demonstrate stable or improved organ function.
OUTLINE: Patients receive human immune globulin IV (IGIV) once weekly for 3 months and then
once biweekly for 9 months, for a total of 12 months in the absence of disease progression
or unacceptable toxicity.
Patients undergo blood sample collection to measure serum anti-fibril antibody titers pre-
and post- IGIV infusion for assessing safety and response to treatment.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Confirmed diagnosis of cardiac-associated primary (AL) amyloidosis based on accepted
clinical and laboratory criteria
- Patients must have heart involvement as evidenced by elevated serum brain natriuretic
peptide, troponin levels, and/or 2D echocardiography evidence of a thickened
intraventricular septum
- No non-AL amyloidosis
PATIENT CHARACTERISTICS:
- Life expectancy > 3 months
- No NYHA class IV heart disease
- No significant comorbidity (e.g., uncontrolled infection, diabetes, or other serious
illnesses)
PRIOR CONCURRENT THERAPY:
- Prior or concurrent chemotherapy or other drug-based anti-AL regimes allowed
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| NCT ID: |
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NCT00547365 |
| Primary Contact: |
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Study Chair
Alan Solomon, MD
St. Mary's Medical Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Powell, Tennessee 37849
United States
Alan Solomon, MD
Phone: 865-545-8126
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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