Phase 2
Completed N=10
Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction
Multiple Myeloma · Plasma Cell Neoplasm
Source: ClinicalTrials.gov NCT00547365 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: 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. — 0 events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
— | — |
| PRIMARY Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV) |
1 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00547365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.