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Home > "H" Clinical Trials Conditions > High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis  High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
For Condition: stage 2 multiple myeloma,stage 1 multiple myeloma,stage 3 multiple myeloma,primary systemic amyloidosis,refractory plasma cell neoplasm
Status: Recruiting
Sponsor(s): Fox Chase Cancer Center ,
Synopsis: RATIONALE: Chemotherapy and peripheral stem cell transplantation may be effective in treating patients with amyloidosis. PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan followed by peripheral stem cell transplantation in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KennethMangan, Study Chair, Fox Chase Cancer Center
Fox Chase - Temple Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2442
United States
Recruiting Kenneth Mangan 215-214-3129
Additional Information:
Study ID Numbers: CDR0000064938; TUHSC-2797,NCI-V96-0951
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002810
Other Stage 2 Multiple Myeloma Studies:
1. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
2. High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
3. Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
4. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
5. Second Autologous Stem Cell Transplantation in Treating Patients With Persistent or Recurrent Primary Systemic (AL) Amyloidosis
Related Studies:
Other stage 2 multiple myeloma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
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