Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis
NCT ID: NCT00017680
Last Updated: 2008-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
1999-07-31
2004-04-30
Brief Summary
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II. Determine the toxicity of this regimen in these patients.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Melphalan
100 mg/m2 twice a day from Days -2 and -1 as induction therapy
Autologous Stem Cell Transplantation
Bone marrow and peripheral blood stem cells harvested
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Herbert Irving Comprehensive Cancer Center
OTHER
Responsible Party
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Columbia University
Principal Investigators
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Charles S. Hesdorffer
Role: STUDY_CHAIR
Herbert Irving Comprehensive Cancer Center
Locations
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Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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CPMC-IRB-9041
Identifier Type: -
Identifier Source: secondary_id
CPMC-CAMP-009A
Identifier Type: -
Identifier Source: secondary_id
199/15927
Identifier Type: -
Identifier Source: org_study_id