Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis
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|ClinicalTrials.gov Identifier: NCT00017680|
Recruitment Status : Completed
First Posted : June 6, 2001
Last Update Posted : June 9, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyloidosis||Drug: Melphalan Procedure: Autologous Stem Cell Transplantation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||April 2004|
|Actual Study Completion Date :||April 2004|
- Drug: Melphalan
100 mg/m2 twice a day from Days -2 and -1 as induction therapy
- Procedure: Autologous Stem Cell Transplantation
Bone marrow and peripheral blood stem cells harvested
- Response, disease-free survial, and overall survial; response will be determined by the change in organ dysfunction
- Toxicity of high dose chemotherapy regimen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017680
|United States, New York|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|Study Chair:||Charles S. Hesdorffer||Herbert Irving Comprehensive Cancer Center|