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Sponsored by: |
Boston Medical Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075621 |
RATIONALE: Autologous stem cell transplantation may be effective treatment for primary systemic (AL) amyloidosis.
PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell transplantation works in treating patients with primary systemic (AL) amyloidosis.
Condition | Intervention | Phase |
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: filgrastim Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Bone Marrow Transplantation Cancer Multiple Myeloma |
ChemIDplus related topics: | Filgrastim Melphalan Melphalan hydrochloride Sarcolysin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Tandem Transplantation in AL Amyloidosis |
Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE:
Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2. Patients undergo autologous stem cell transplantation (ASCT) on day 0.
Treatment continues in the absence of unacceptable toxicity.
Patients are followed at 3 and 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 2-3 years.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed AL amyloidosis, meeting 1 of the following criteria:
Plasma cell dyscrasia, evidenced by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Massachusetts | |||||
Cancer Research Center at Boston Medical Center | |||||
Boston, Massachusetts, United States, 02118 |
Boston Medical Center |
Principal Investigator: | Vaishali Sanchorawala, MD | Boston Medical Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000347381, BUMC-2000-0279 |
First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075621 |
Health Authority: | United States: Federal Government |
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