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Sponsored by: |
Boston Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075608 |
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 stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.
PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Second Autologous Transplantation in AL Amyloidosis |
Estimated Enrollment: | 19 |
Study Start Date: | August 2001 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
Patients are followed at 6 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 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
Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 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
United States, Massachusetts | |
Boston University Cancer Research Center | Recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-353-7571 |
Principal Investigator: | Karen Quillen, MD | Boston Medical Center |
Responsible Party: | Boston University Cancer Research Center ( Karen Quillen ) |
Study ID Numbers: | CDR0000347379, BUMC-2001-0156 |
Study First Received: | January 9, 2004 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00075608 History of Changes |
Health Authority: | Unspecified |
primary systemic amyloidosis |
Melphalan Immunoproliferative Disorders Metabolic Diseases Blood Protein Disorders Hematologic Diseases Primary Amyloidosis Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Recurrence Multiple Myeloma Amyloidosis Hemorrhagic Disorders Lymphoproliferative Disorders Metabolic Disorder Neoplasms, Plasma Cell |
Immunoproliferative Disorders Metabolic Diseases Neoplasms by Histologic Type Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Amyloidosis Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |