Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
Recruitment status was Recruiting
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.
Multiple Myeloma and Plasma Cell Neoplasm
Biological: therapeutic immune globulin
Other: laboratory biomarker analysis
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis|
- Level of tolerance for human immune globulin intravenous (IGIV) as reflected by the number and severity of toxicity incidents [ Designated as safety issue: Yes ]
- Clinical responses as evidenced by increased serum anti-fibril IgG antibody levels post-IGIV infusion and reduction (or no evident progression) in amyloid burden [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- 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.
|United States, Tennessee|
|Baptist Regional Cancer Center at Baptist Riverside||Recruiting|
|Knoxville, Tennessee, United States, 37901|
|Contact: Clinical Trials Office - Baptist Regional Cancer Center 865-632-5717|
|St. Mary's Medical Center||Recruiting|
|Powell, Tennessee, United States, 37849|
|Contact: Alan Solomon, MD 865-545-8126|
|Study Chair:||Alan Solomon, MD||St. Mary's Medical Center|