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

Phase 1

Completed

• Conditions: Multiple Myeloma; Plasma Cell Neoplasm
• Interventions: Biological: Human immune globulin intravenous (IGIV)

• Registration Number: NCT00547365
• Lead Sponsor: University of Tennessee

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-19
• Study First Submitted QC: 2007-10-19
• Study First Posted: 2007-10-22
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2013-02-04
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-16
• Last Update Submitted: 2013-09-16
• Results First Posted: 2013-09-19
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)	Up to 1 year	Positive clinical response was defined by improvement in heart function in participating patients with cardiac-dominant AL amyloidosis, as demonstrated by increased serum anti-fibril immunoglobulin G (IgG) antibody levels and reduction (or no evident progression) in amyloid burden.
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.	Up to 1 year

Trial Locations

Locations (2)

St. Mary's Medical Center; 🇺🇸 Powell, Tennessee, United States

Baptist Regional Cancer Center at Baptist Riverside; 🇺🇸 Knoxville, Tennessee, United States