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| Sponsored by: |
Fox Chase Cancer Center CCOP Research Base |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002810 |
Purpose
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 peripheral 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 giving high-dose melphalan together with peripheral stem cell transplant works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: filgrastim Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL) |
| Study Start Date: | May 1996 |
OBJECTIVES:
OUTLINE: Peripheral blood stem cells (PBSC) are mobilized with granulocyte colony-stimulating factor (G-CSF) for 5 days and then collected by leukapheresis. Patients receive high-dose melphalan on 2 consecutive days, followed by 1 day of rest, then by PBSC transplantation. G-CSF is given from 1 day after transplantation until the neutrophil count is greater than 1,500 for 3 consecutive days.
Patients are followed at 100 days and 1 year post-transplant.
PROJECTED ACCRUAL: A very small number of patients are expected to be accrued over 5-10 years.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Primary amyloidosis diagnosed by appropriate amyloid stains or electromicroscopy of abdominal fat, bone marrow, or other target tissues
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Pennsylvania | |
| Fox Chase-Temple Cancer Center CCOP Research Base | |
| Philadelphia, Pennsylvania, United States, 19111-2442 | |
| Study Chair: | Kenneth F. Mangan, MD, FACP | Fox Chase Cancer Center CCOP Research Base |
More Information
| Study ID Numbers: | CDR0000064938, TUHSC-2797, NCI-V96-0951 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002810 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma primary systemic amyloidosis |
|
Melphalan Metabolic Diseases Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Primary Amyloidosis Blood Coagulation Disorders Vascular Diseases Paraproteinemias |
Hemostatic Disorders Immunosuppressive Agents Multiple Myeloma Amyloidosis Hemorrhagic Disorders Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Alkylating Agents Metabolic Disorder Neoplasms, Plasma Cell |
|
Melphalan Molecular Mechanisms of Pharmacological Action Immunologic Factors Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Neoplasms by Histologic Type Metabolic Diseases |
Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Amyloidosis Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Neoplasms, Plasma Cell |