Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL)
filgrastim
+ melphalan
+ bone marrow ablation with stem cell support
Amyloidosis+17
+ Blood Protein Disorders
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: May 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fox Chase-Temple Cancer Center CCOP Research Base
Philadelphia, United StatesOpen Fox Chase-Temple Cancer Center CCOP Research Base in Google Maps