Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis
- 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.
Primary Purpose: Treatment
Level of tolerance for human immune globulin intravenous (IGIV) as reflected by the number and severity of toxicity incidents
Alan Solomon, MD
St. Mary's Medical Center
|Baptist Regional Cancer Center at Baptist Riverside||Knoxville, Tennessee 37901|
|St. Mary's Medical Center||Powell, Tennessee 37849|