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

University of Tennessee

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma; Plasma Cell Neoplasm

Treatments: Biological: Human immune globulin intravenous (IGIV)

Study type: Interventional

Funder types: Other

Identifiers

NCT00547365

UTCI-2645 (Other Identifier)

CDR0000572104

BRCC-BHS-06127 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 illnesses)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Human immune globulin intravenous (IGIV)

Experimental group

Description:

Analyze the therapeutic potential of human immune globulin intravenous (IGIV) when given to patients with cardiac-associated AL amyloidosis

Treatment:

Biological: Human immune globulin intravenous (IGIV)