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Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in


Phase 2
18 Years
70 Years
Not Enrolling
Both
Amyloidosis

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Trial Information

Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in


PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients
then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood
stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days.

Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC
and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and
continuing until blood counts recover. This course may be repeated 4-12 weeks later.

Patients are followed every 3 months for 1 year and then annually for 5 years.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

Disease Characteristics

- Histologically confirmed primary amyloidosis

- Ineligible for other high priority national or international study

Prior/Concurrent Therapy

- Biologic therapy: Concurrent participation in gene therapy trials allowed

- Chemotherapy: Prior chemotherapy allowed No other concurrent chemotherapy

- Endocrine therapy: No concurrent steroids unless given with amphotericin B, for
adrenal failure, or for septic shock No concurrent hormones except for
non-disease-related conditions (e.g., insulin for diabetes)

- Other: No concurrent barbiturates or acetaminophen Concurrent participation in
supportive care trials allowed

Patient Characteristics

- Performance status: ECOG 0-3

- Hepatic: Bilirubin less than 2 times normal

- Renal: Creatinine less than 2.5 mg/dL OR On stable hemodialysis

- Pulmonary: DLCO at least 60% predicted OR Clearance by pulmonologist

- Other: HIV negative

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response, disease-free survial, and overall survial; response will be determined by the change in organ dysfunction

Principal Investigator

Charles S. Hesdorffer

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

199/15927

NCT ID:

NCT00017680

Start Date:

July 1999

Completion Date:

April 2004

Related Keywords:

  • Amyloidosis
  • amyloidosis
  • arthritis & connective tissue diseases
  • genetic diseases and dysmorphic syndromes
  • hematopoietic/lymphoid cancer
  • oncologic disorders
  • plasma cell neoplasm
  • primary systemic amyloidosis
  • rare disease
  • Amyloidosis

Name

Location
Herbert Irving Comprehensive Cancer Center New York, New York  10032