Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis

• Status: Completed
• Trial end date: 2020-09-04
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Autologous stem cell transplantation may be effective treatment for primary systemic (AL) amyloidosis.

PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell transplantation works in treating patients with primary systemic (AL) amyloidosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Treatments: Lenograstim; Melphalan

Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Histologically confirmed AL amyloidosis, meeting 1 of the following criteria:

• Plasma cell dyscrasia, evidenced by 1 of the following:

• Monoclonal protein in the serum or urine by immunofixation electrophoresis

• Plasmacytosis of the bone marrow with monoclonal staining for kappa or lambda light chain isotype

• Macroglossia with at least 1 other site having biopsy proven amyloidosis and absence of a mutant transthyretin is ruled out

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Performance status

• SWOG 0-2

Life expectancy

• At least 1 year

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• LVEF ≥ 45% by MUGA or echocardiogram

Pulmonary

• DLCO ≥ 50%

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Able to tolerate 2 courses of high-dose therapy

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Prior alkylating agent chemotherapy allowed provided there is no morphologic or cytogenetic evidence of myelodysplastic syndromes

• Prior total cumulative oral melphalan dose < 300 mg

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 4 weeks since prior cytotoxic therapy and recovered

Exclusion Criteria:

• No senile, secondary, localized, dialysis-related, or familial amyloidosis

• No overt multiple myeloma (e.g., greater than 30% bone marrow plasmacytosis, extensive [more than 2] lytic lesions, hypercalcemia)

Cardiovascular

• No myocardial infarction within the past 6 months

• No congestive heart failure

• No arrhythmia refractory to therapy

• No evidence of symptomatic transient ischemic attacks or strokes

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission