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

NCT00547365 | Completed Phase 1 Results

• 3 other identifiers: CDR0000572104BRCC-BHS-06127UTCI-2645
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma; Plasma Cell Neoplasm

Keywords

primary systemic amyloidosis

Outcome Measures

Primary Outcomes (2)

• 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

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

  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.

  Up to 1 year

Study Arms (1)

Human immune globulin intravenous (IGIV)

EXPERIMENTAL

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

Biological: Human immune globulin intravenous (IGIV)

Interventions

Human immune globulin intravenous (IGIV) BIOLOGICAL

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

Human immune globulin intravenous (IGIV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (2)

Baptist Regional Cancer Center at Baptist Riverside

Knoxville, Tennessee, 37901, United States

Location

St. Mary's Medical Center

Powell, Tennessee, 37849, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Immunoglobulin Light-chain Amyloidosis

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Alan Solomon, MD
• Organization: University of Tennessee Graduate School of Medicine

asolomon@utmck.edu

865-305-9167

Study Officials

• Alan Solomon, MD

  St. Mary's Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 19, 2013
• Results First Posted: September 19, 2013

Record last verified: 2013-09

Locations

US (2)