Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amylo… (NCT00075621) | Clinical Trial Compass
CompletedPhase 2
Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
United States62 participantsStarted 2000-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 tha…