Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Level of tolerance for human immune globulin intravenous (IGIV) as reflected by the number and severity of toxicity incidents
Safety Issue:
Yes
Principal Investigator
Alan Solomon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Mary's Medical Center
Authority:
Unspecified
Study ID:
CDR0000572104
NCT ID:
NCT00547365
Start Date:
October 2007
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- primary systemic amyloidosis
- Amyloidosis
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Baptist Regional Cancer Center at Baptist Riverside | Knoxville, Tennessee 37901 |
| St. Mary's Medical Center | Powell, Tennessee 37849 |
