2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Multiple Myeloma, Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring primary systemic amyloidosis
Eligibility Criteria
Inclusion criteria: DISEASE CHARACTERISTICS: Histologically confirmed AL amyloidosis Persistent or recurrent disease after 1 course of prior high-dose chemotherapy Previously treated with autologous stem cell transplantation Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 1 of the following: Complete hematologic remission (e.g., absence of monoclonal spike by immunofixation in serum and urine AND less then 5% plasma cells in bone marrow with no clonal predominance) OR partial hematologic response (e.g., any decrease in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis) Greater than 50% reduction in proteinuria with preservation of creatinine clearance Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in liver size by physical exam Subjective neurologic improvement, as confirmed by neurologist Cardiac stabilization of disease confirmed by echocardiography defined as less than 2 mm increase in mean wall thickness and/or less than 20 g increase in left ventricular mass Improvement in performance status* NOTE: *This criteria alone does not constitute significant improvement in organ function Prior stem cell yield must have been ≥ 2 x 10^6 CD34+ cells/kg PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics No chemotherapy after first transplantation Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified PATIENT CHARACTERISTICS: Age 18 to 65 Performance status Southwest Oncology Group- 0-2 Life expectancy More than 6 months Hematopoietic See Disease Characteristics Hepatic See Disease Characteristics Renal See Disease Characteristics Cardiovascular See Disease Characteristics Left ventricular ejection fraction ≥ 45% by multiple gated acquisition scan or echocardiogram Pulmonary diffusing capacity of lung for carbon monoxide ≥ 50% Exclusion Criteria: No myelodysplastic syndromes No abnormal bone marrow cytogenetics Other Not pregnant or nursing Fertile patients must use effective contraception Acceptable toxicity from first transplantation, confirmed by the transplant team HIV negative No other concurrent malignancy except treated skin cancer
Sites / Locations
- Boston University Cancer Research Center
Arms of the Study
Arm 1
Experimental
2nd Stem Cell Transplant
Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion