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

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00075621

Run by

Boston Medical Center

People needed

62

Starts

2000-08-01

Expected to finish

2020-09-04

Last updated by the study team

2020-09-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Research Center at Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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