Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Amyloidosis

Immunoglobulin Light-chain Amyloidosis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Proteostasis Deficiencies

Metabolic Diseases

AL Amyloidosis

All Drugs and Chemicals

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Immunologic Factors

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

Human immune globulin intravenous (IGIV)

Alan Solomon, MD

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.

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

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.

University of Tennessee

Professor of Medicine

Therapeutic potential of human immune globulin intravenous (IGIV)in patients with cardiac-associated AL amyloidosis

Human Immune Globulin Intravenous (IGIV)

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Patients with cardiac-dominant AL amyloidosis, as determined from standard clinical tests (IVS, BNP),were entered on study.

Immune globulin intravenous (IGIV) was administered to patients with cardiac-dominant AL amyloidosis in order to determine its therapeutic potential or possible toxicity when given to subjects weekly for 3 months and then every other week for the next 9 months. Response was evaluated by changes in serum anti-fibril antibody levels, changes in BNP (B-type natriuretic peptide) levels and IVS (interventricular septum) thickness.

All patients who had at least one infusion of human immune globulin intravenous.

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.

Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.

Two of ten patients with AL cardiac involvement who received IGIV infusions were analyzed (other eight individuals were removed from study before completion due to death/conditions unrelated to IGIV, loss to follow-up, or physician decision).

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

The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was \~1 yr.

Overall Study

Spots Global Cancer Trial Database for human immune globulin intravenous (igiv)