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| ID | Type | Description | Link |
|---|---|---|---|
| BHO-H-25876 | Other Identifier | ||
| BUMC-H-25876 | Other Identifier | Boston University Medical Center IRB |
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Poor accrual
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RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This phase II trial is studying the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.
OBJECTIVES:
OUTLINE:
After completion of study therapy, patients are followed at 3, 6, and 12 months and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT with melphalan conditioning | Experimental | Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematologic Response Rate | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Predictability of Early Free Light-chain Response for Heme Response | One month | |
| Organ or Clinical Response | One year | |
| Overall Survival |
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Inclusion Criteria:
DISEASE CHARACTERISTICS:
Histologically confirmed light-chain deposition disease based on the following criteria:
Deposition of granular material containing free light-chain (FLC) immunoglobulins that did not bind Congo red
Evidence of a plasma cell dyscrasia, as defined by any of the following:
Patients may enroll after stem cell collection (SCC) if all prestudy requirements are completed prior to starting SCC (i.e., ≥ 2.5 x 10^6 cells available for transplantation)
PRIOR CONCURRENT THERAPY:
PATIENT CHARACTERISTICS:
Exclusion Criteria:
No overt multiple myeloma, as defined by any of the following:
No myocardial infarction, congestive heart failure, or arrhythmia refractory to therapy within the past 6 months
No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete response, or any other cancer from which the patient has been disease-free for the past 5 years
No HIV positivity
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| Name | Affiliation | Role |
|---|---|---|
| Vaishali Sanchorawala, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
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A patient enrolled on this study but was withdrawn due to insufficient stem cell yield. His clinical situation changed 5 months later and the investigators believed he would have a better yield so he was enrolled for a second time. Therefore, there were 5 enrollments, but 4 patients.
Patients were enrolled from the Boston Medical Center Stem Cell Transplant Program between 2006 and 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | SCT With Melphalan Conditioning | Mobilization with Filgrastim Stem Cell collection (SCC) Melphalan Conditioning Stem Cell infusion filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC melphalan: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2 Stem Cell Infusion: infusion of previously collected stem cells on Day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCT With Melphalan Conditioning | Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC melphalan: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2 Stem Cell Infusion: infusion of previously collected stem cells on Day 0 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hematologic Response Rate | No data were collected or analyzed due to study termination | Posted | one year |
|
|
100 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCT With Melphalan Conditioning | Mobilization with Filgrastim Stem Cell collection Melphalan Conditioning Stem Cell infusion filgrastim: 16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC melphalan: 70-100 mg/m2/day will be administered intravenously on Days -3 and -2 Stem Cell Infusion: infusion of previously collected stem cells on Day 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drug reaction | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vaishali Sanchorawala, Director of Stem Cell Transplant Program | Boston Medical Center | 617-637-7017 | vaishali.sanchorawala@bmc.org |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C455861 | pegfilgrastim |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| melphalan | Drug | 70-100 mg/m2/day will be administered intravenously on Days -3 and -2 |
|
|
| Stem Cell Infusion | Procedure | infusion of previously collected stem cells on Day 0 |
|
| life |
| Tolerability | 100 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Secondary | Predictability of Early Free Light-chain Response for Heme Response | No data were collected or analyzed due to study termination | Posted | One month |
|
|
| Secondary | Organ or Clinical Response | No data were collected or analyzed due to study termination | Posted | One year |
|
|
| Secondary | Overall Survival | No data were collected or analyzed due to study termination | Posted | life |
|
|
| Secondary | Tolerability | No data were collected or analyzed due to study termination | Posted | 100 days |
|
|
| 0 |
| 4 |
| 4 |
| 4 |
| 4 |
| 4 |
| vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| dehydration | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Toxic Epidermal Necrosis (TEN) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment | related to fluid overload |
|
| joint pain | General disorders | CTCAE (3.0) | Non-systematic Assessment | gout |
|
| mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| voice changes | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hypoalbuminemia | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| renal failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| renal insufficiency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| increased creatinine | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| febrile neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| insomnia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| rigors | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dehydration | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| anorexia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| sinus tacchycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| peripheral edema | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment | grand mal |
|
| joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| bilateral pleural effusions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| mucositis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| elevated ALT | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hypoalbuminemia | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| elevated alk phos | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| line bleed | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |