High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis - Article Alkeran; L-PAM
Clinical Trial: High-Dose Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Amyloidosis
This study is currently recruiting patients.
PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with peripheral stem cell transplantation works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma.
|Condition||Treatment or Intervention||Phase|
|refractory plasma cell neoplasm |
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
primary systemic amyloidosis
| Drug: filgrastim |
Procedure: biological response modifier therapy
Procedure: bone marrow ablation with stem cell support
Procedure: colony-stimulating factor therapy
Procedure: cytokine therapy
Procedure: high-dose chemotherapy
Procedure: peripheral blood stem cell transplantation
|Phase II |
MedlinePlus related topics: Immune System and Disorders; Lymphatic Diseases; Metabolic Disorders; Multiple Myeloma
Study Type: Interventional
Study Design: Treatment
- 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.
Ages Eligible for Study: 16 Years - 65 Years, Genders Eligible for Study: Both
- 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
- Karnofsky 80-100%
- Not specified
- Liver function tests less than twice normal
- No active liver disease
- Creatinine clearance greater than 50 mL/min
- Nephrotic syndrome allowed
- Cardiac evaluation required in patients with left ventricular ejection fraction less than 45% by echocardiogram or MUGA
- No poorly controlled hypertension
- FEV_1 and DLCO greater than 50% of predicted, or pulmonary evaluation required
- No chronic obstructive pulmonary disease
- 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
- Corticosteroids discontinued at least 6 weeks prior to transplantation
- No prior radiotherapy
- Not specified
Location and Contact Information
Fox Chase - Temple Cancer Center, Philadelphia, Pennsylvania, 19111-2442, United States; Recruiting
Kenneth F. Mangan, MD, Study Chair, Fox Chase Cancer Center
Record last reviewed: September 2003
Last Updated: February 24, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002810
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005