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

Information source: University of Tennessee
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma; Plasma Cell Neoplasm

Intervention: Human immune globulin intravenous (IGIV) (Biological)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of Tennessee

Official(s) and/or principal investigator(s):
Alan Solomon, MD, Study Chair, Affiliation: St. Mary's Medical Center


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.

Clinical Details

Official title: Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated Light Chain (AL) Amyloidosis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One Infusion of IGIV.

Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)

Detailed description: 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 light chain-associated (AL) amyloidosis.

- Determine the safety, pharmokinetics, and therapeutic efficacy as evidenced by titers

of serum fibril-reactive immunoglobulin G (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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion criteria:

- 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

Exclusion criteria:

- Non-AL amyloidosis

- New York Heart Association (NYH) class IV heart disease

- Significant comorbidity (e. g., uncontrolled infection, diabetes, or other serious


Locations and Contacts

Baptist Regional Cancer Center at Baptist Riverside, Knoxville, Tennessee 37901, United States

St. Mary's Medical Center, Powell, Tennessee 37849, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2007
Last updated: September 16, 2013

Page last updated: August 20, 2015

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