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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alan Solomon, University of Tennessee
ClinicalTrials.gov Identifier:
NCT00547365
First received: October 19, 2007
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Plasma Cell Neoplasm
Biological: Human immune globulin intravenous (IGIV)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated Light Chain (AL) Amyloidosis

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 10
Study Start Date: October 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human immune globulin intravenous (IGIV)
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)
Analyze the therapeutic potential of human immune globulin intravenous (IGIV) when given to patients with cardiac-associated AL amyloidosis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547365

Locations
United States, Tennessee
Baptist Regional Cancer Center at Baptist Riverside
Knoxville, Tennessee, United States, 37901
St. Mary's Medical Center
Powell, Tennessee, United States, 37849
Sponsors and Collaborators
University of Tennessee
Investigators
Study Chair: Alan Solomon, MD St. Mary's Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alan Solomon, Professor of Medicine, University of Tennessee
ClinicalTrials.gov Identifier: NCT00547365     History of Changes
Other Study ID Numbers: CDR0000572104, BRCC-BHS-06127, UTCI-2645
Study First Received: October 19, 2007
Results First Received: February 4, 2013
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
primary systemic amyloidosis

Additional relevant MeSH terms:
Amyloidosis
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014