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Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis



Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis

For Condition: Amyloidosis
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center ,
Synopsis: OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of patients with primary light chain amyloidosis treated with high-dose melphalan and autologous stem cell transplantation. II. Determine the toxicity of this regimen in these patients.
Details: PROTOCOL OUTLINE: Patients may receive induction chemotherapy before study entry. Patients then receive filgrastim (G-CSF) or another growth factor for 4-6 days as peripheral blood stem cell (PBSC) mobilization. PBSC (or bone marrow) is harvested over 2-3 days. Patients receive high-dose melphalan IV over 30 minutes twice daily on days -2 and -1. PBSC and/or bone marrow is reinfused on day 0. Patients receive G-CSF beginning on day 0 and continuing until blood counts recover. This course may be repeated 4-12 weeks later. Patients are followed every 3 months for 1 year and then annually for 5 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: Disease Characteristics - Histologically confirmed primary amyloidosis - Ineligible for other high priority national or international study Prior/Concurrent Therapy - Biologic therapy: Concurrent participation in gene therapy trials allowed - Chemotherapy: Prior chemotherapy allowed No other concurrent chemotherapy - Endocrine therapy: No concurrent steroids unless given with amphotericin B, for adrenal failure, or for septic shock No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes) - Other: No concurrent barbiturates or acetaminophen Concurrent participation in supportive care trials allowed Patient Characteristics - Performance status: ECOG 0-3 - Hepatic: Bilirubin less than 2 times normal - Renal: Creatinine less than 2.5 mg/dL OR On stable hemodialysis - Pulmonary: DLCO at least 60% predicted OR Clearance by pulmonologist - Other: HIV negative
Total Enrollment: 25

Location and Contact Information:

Overall Study Official:
CharlesHesdorffer,  Study Chair,  Herbert Irving Comprehensive Cancer Center

Herbert Irving Comprehensive Cancer Center *Recruiting*
New York City,  New York,  10032
United States
Recruiting William  Sherman 212-305-3856


Additional Information:
Study ID Numbers:
  199/15927;  CPMC-IRB-9041,CPMC-CAMP-009A
Study Start Date: July 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017680

Other Amyloidosis Studies:
1. Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis

2. Study of Systemic Amyloidosis Presentation and Prognosis

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