Know Cancer

or
forgot password

Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

Therapeutic Potential of Human Immune Globulin Intravenous (IGIV) in Patients With Cardiac-Associated AL Amyloidosis


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 amyloidosis.

- Determine the safety, pharmakinetics, and therapeutic efficacy as evidenced by titers
of serum fibril-reactive 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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, troponin levels, and/or 2D echocardiography evidence of a thickened
intraventricular septum

- No non-AL amyloidosis

PATIENT CHARACTERISTICS:

- Life expectancy > 3 months

- No NYHA class IV heart disease

- No significant comorbidity (e.g., uncontrolled infection, diabetes, or other serious
illnesses)

PRIOR CONCURRENT THERAPY:

- Prior or concurrent chemotherapy or other drug-based anti-AL regimes allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Level of tolerance for human immune globulin intravenous (IGIV) as reflected by the number and severity of toxicity incidents

Safety Issue:

Yes

Principal Investigator

Alan Solomon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Mary's Medical Center

Authority:

Unspecified

Study ID:

CDR0000572104

NCT ID:

NCT00547365

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Baptist Regional Cancer Center at Baptist RiversideKnoxville, Tennessee  37901
St. Mary's Medical CenterPowell, Tennessee  37849