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Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL)


Phase 2
16 Years
65 Years
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL)


OBJECTIVES:

- Assess overall and progression-free survival following high-dose melphalan and
autologous peripheral blood stem cell transplantation in patients with primary
amyloidosis.

- Evaluate the toxic effects associated with this treatment regimen.

- Evaluate the function of involved organs, especially the heart, lungs, and nervous
system, before and after treatment with this regimen.

OUTLINE: Peripheral blood stem cells (PBSC) are mobilized with granulocyte
colony-stimulating factor (G-CSF) for 5 days and then collected by leukapheresis. Patients
receive high-dose melphalan on 2 consecutive days, followed by 1 day of rest, then by PBSC
transplantation. G-CSF is given from 1 day after transplantation until the neutrophil count
is greater than 1,500 for 3 consecutive days.

Patients are followed at 100 days and 1 year post-transplant.

PROJECTED ACCRUAL: A very small number of patients are expected to be accrued over 5-10
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Primary amyloidosis diagnosed by appropriate amyloid stains or electromicroscopy of
abdominal fat, bone marrow, or other target tissues

- Pathology reviewed by Temple University

- Amyloidosis secondary to any stage of multiple myeloma allowed provided plasma cell
concentration in bone marrow is less than 15%

- No amyloidosis secondary to rheumatoid arthritis or chronic infection

- No familial amyloidosis

PATIENT CHARACTERISTICS:

Age:

- 16 to 65

Performance status:

- Karnofsky 80-100%

Hematopoietic:

- Not specified

Hepatic:

- Liver function tests less than twice normal

- No active liver disease

Renal:

- Creatinine clearance greater than 50 mL/min

- Nephrotic syndrome allowed

Cardiovascular:

- Cardiac evaluation required in patients with left ventricular ejection fraction less
than 45% by echocardiogram or MUGA

- No poorly controlled hypertension

Pulmonary:

- FEV_1 and DLCO greater than 50% of predicted, or pulmonary evaluation required

- No chronic obstructive pulmonary disease

Other:

- No history of serious coagulopathy, hemorrhage, or bleeding

- No active infection

- No other serious comorbid disease (e.g., poorly controlled diabetes)

- No pregnant women

- Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- More than 12 monthly cycles of prior alkylating agent chemotherapy discouraged

Endocrine therapy:

- Corticosteroids discontinued at least 6 weeks prior to transplantation

Radiotherapy:

- No prior radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Kenneth F. Mangan, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064938

NCT ID:

NCT00002810

Start Date:

May 1996

Completion Date:

May 2006

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Fox Chase-Temple Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19111-2442