Multiple Myeloma Clinical Trial
Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy.
PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.
Full Description
OBJECTIVES:
Determine the maximum tolerated dose (MTD) of high-dose melphalan administered with amifostine in patients with primary systemic amyloidosis undergoing autologous peripheral blood stem cell transplantation.
Determine the toxicity of high-dose melphalan when administered at the MTD in these patients.
Determine the response rate in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of melphalan.
Patients receive filgrastim (G-CSF) subcutaneously once daily until peripheral blood stem cell (PBSC) collection is complete. Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected.
Within 6 weeks of PBSC collection, patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 30-60 minutes on day -1. Patients undergo autologous PBSC infusion on day 0.
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose.
Patients are followed approximately 3 months following transplantation, then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within 2.3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed amyloidosis
No secondary familial or localized amyloidosis
Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or urine
No primary amyloidosis manifested only by carpal tunnel syndrome or purpura
Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic individual not considered an amyloid syndrome
Amyloid syndromes include any of the following:
Hepatomegaly
Cardiomyopathy
Nephrotic range proteinuria
Peripheral or autonomic neuropathy
No multiple myeloma defined by 1 of the following:
Presence of lytic bone disease
More than 30% bone marrow plasma cells
PATIENT CHARACTERISTICS:
Age
18 to 70
Performance status
ECOG 0-1
Life expectancy
Not specified
Hematopoietic
Platelet count at least 100,000/mm^3
Hepatic
See Disease Characteristics
Total or direct bilirubin no greater than 2.0 mg/dL
Alkaline phosphatase no greater than 4 times upper limit of normal
Renal
See Disease Characteristics
Creatinine less than 3.0 mg/dL
Cardiovascular
See Disease Characteristics
Ejection fraction at least 45% by echocardiogram
No New York Heart Association class III or IV heart disease
Systolic blood pressure ≥ 90 mmHg
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 4 weeks since prior interferon
Chemotherapy
At least 4 weeks since prior melphalan
Lifetime total melphalan dose less than 150 mg/m^2 (based on ideal body weight)
Endocrine therapy
At least 4 weeks since prior dexamethasone
Radiotherapy
No prior radiotherapy for amyloidosis
Surgery
Not specified
Other
No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour after amifostine administration
No other prior treatment
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There are 15 Locations for this study
Scottsdale Arizona, 85259, United States
Indianapolis Indiana, 46202, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Cleveland Ohio, 44106, United States
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