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| ID | Type | Description | Link |
|---|---|---|---|
| CPMC-IRB-9041 | |||
| CPMC-CAMP-009A |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melphalan | Drug | 100 mg/m2 twice a day from Days -2 and -1 as induction therapy | ||
| Autologous Stem Cell Transplantation | Procedure | Bone marrow and peripheral blood stem cells harvested |
| Measure | Description | Time Frame |
|---|---|---|
| Response, disease-free survial, and overall survial; response will be determined by the change in organ dysfunction |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of high dose chemotherapy regimen |
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PROTOCOL ENTRY CRITERIA:
Disease Characteristics
Prior/Concurrent Therapy
Patient Characteristics
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| Name | Affiliation | Role |
|---|---|---|
| Charles S. Hesdorffer | Herbert Irving Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| D001168 | Arthritis |
| D003240 | Connective Tissue Diseases |
| D030342 | Genetic Diseases, Inborn |
| D019337 | Hematologic Neoplasms |
| D054219 | Neoplasms, Plasma Cell |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| D009140 | Musculoskeletal Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |