Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma, Plasma Cell Neoplasm

In brief

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.

Key facts

Study ID

NCT00547365

Run by

University of Tennessee

People needed

10

Starts

2007-10-01

Expected to finish

2011-07-01

Last updated by the study team

2013-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (BNP), troponin levels, and/or 2D echocardiography evidence of a thickened intraventricular septum (IVS).
• Life expectancy > 3 months
• Prior or concurrent chemotherapy or other drug-based anti-AL regimes allowed

You may not qualify if…

• Non-AL amyloidosis
• New York Heart Association (NYH) class IV heart disease
• Significant comorbidity (e.g., uncontrolled infection, diabetes, or other serious illnesses)

Where it is running

• Baptist Regional Cancer Center at Baptist Riverside — Knoxville, Tennessee, United States
• St. Mary's Medical Center — Powell, Tennessee, United States

Full record on ClinicalTrials.gov

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