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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

October 19, 2007
September 16, 2013
October 2007
July 2011   (final data collection date for primary outcome measure)
  • 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.
  • Level of tolerance for human immune globulin intravenous (IGIV) as reflected by the number and severity of toxicity incidents
  • Clinical responses as evidenced by increased serum anti-fibril IgG antibody levels post-IGIV infusion and reduction (or no evident progression) in amyloid burden
Complete list of historical versions of study NCT00547365 on ClinicalTrials.gov Archive Site
Not Provided
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Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated Light Chain (AL) Amyloidosis

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Plasma Cell Neoplasm
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
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
Intervention: Biological: Human immune globulin intravenous (IGIV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2011
July 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547365
CDR0000572104, BRCC-BHS-06127, UTCI-2645
No
Alan Solomon, University of Tennessee
University of Tennessee
Not Provided
Study Chair: Alan Solomon, MD St. Mary's Medical Center
University of Tennessee
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP