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

NCT ID: NCT00547365

Last Updated: 2013-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma Plasma Cell Neoplasm

Keywords

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primary systemic amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Human immune globulin intravenous (IGIV)

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

Group Type EXPERIMENTAL

Human immune globulin intravenous (IGIV)

Intervention Type BIOLOGICAL

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

Interventions

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Human immune globulin intravenous (IGIV)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Alan Solomon

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Solomon, MD

Role: STUDY_CHAIR

St. Mary's Medical Center

Locations

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Baptist Regional Cancer Center at Baptist Riverside

Knoxville, Tennessee, United States

Site Status

St. Mary's Medical Center

Powell, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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BRCC-BHS-06127

Identifier Type: OTHER

Identifier Source: secondary_id

UTCI-2645

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000572104

Identifier Type: -

Identifier Source: org_study_id