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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00014029 |
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Low accrual
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
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Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.
This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flu-Bu4 | Experimental | Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine/Busulfan x 4 days | Drug |
The Fludarabine shall be administered prior to the Busulfan each day. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Alive 1 Year Post Transplant | The primary objective is overall survival, one year from the time of transplant. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Free From Progression at 1 Year | One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia. |
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Inclusion Criteria:
Biologic high risk Multiple Myeloma:
Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics.
Age up to 70 years old (less than 71 years old at the date of transplant admission).
Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission
Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant.
Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Attaphol Pawarode, MD | University of Michigan Dept. of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan,Department of Internal Med. Hematology- Oncology | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Flu-Bu4 | Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| stem cell transplant | Procedure | Allogeneic, peripheral blood stem cell transplant |
|
| 1 Year |
| Percentage of Patients With Treatment Related Mortality (TRM) | 100 days, one-year |
| Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD) | Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus | 100 days, 2 years |
| Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression | Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years. | 3 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Flu-Bu4 | Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | The Percentage of Patients Alive 1 Year Post Transplant | The primary objective is overall survival, one year from the time of transplant. | Posted | Number | 95% Confidence Interval | percentage of patients | 1 Year |
|
|
| ||||||||||||||||||||||||||
| Secondary | The Percentage of Patients Free From Progression at 1 Year | One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia. | Posted | Number | 95% Confidence Interval | percentage of patients | 1 Year |
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| Secondary | Percentage of Patients With Treatment Related Mortality (TRM) | Posted | Number | 95% Confidence Interval | percentage of patients | 100 days, one-year |
|
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| Secondary | Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD) | Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus | Posted | Number | 95% Confidence Interval | percentage of participants | 100 days, 2 years |
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| Secondary | Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression | Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years. | Posted | Number | 95% Confidence Interval | percentage of deaths | 3 years |
|
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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 | Flu-Bu4 | Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day. | 13 | 22 | 20 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy/Immunology - Other | Immune system disorders |
| |||
| Blood/Bone Marrow - Other | Blood and lymphatic system disorders |
| |||
| Cardiac General - Other | Cardiac disorders |
| |||
| Hypotension | Cardiac disorders |
| |||
| Fever | General disorders |
| |||
| Death, disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Rash/desquamation | Skin and subcutaneous tissue disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Hemorrhage, bladder | Vascular disorders |
| |||
| Febrile neutropenia | Infections and infestations |
| |||
| Infection with Grade 3 or 4 neutrophils | Infections and infestations |
| |||
| Infection - Other | Infections and infestations |
| |||
| Infection, blood | Infections and infestations |
| |||
| Infection, lung | Infections and infestations |
| |||
| Infection, upper airway | Infections and infestations |
| |||
| Infection, UTI | Infections and infestations |
| |||
| Muscle weakness | Musculoskeletal and connective tissue disorders |
| |||
| Somnolence/depressed level of consciousness | Nervous system disorders |
| |||
| Pain, headache | General disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders |
| |||
| Renal failure | Renal and urinary disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/Bone Marrow - Other | Blood and lymphatic system disorders |
| |||
| Platelets | Blood and lymphatic system disorders |
| |||
| Sinus bradycardia | Cardiac disorders |
| |||
| Sinus tachycardia | Cardiac disorders |
| |||
| Supraventricular extrasystoles | Cardiac disorders |
| |||
| Hypertension | Cardiac disorders |
| |||
| Hypotension | Cardiac disorders |
| |||
| Fatigue (asthenia, lethargy, malaise) | General disorders |
| |||
| Fever | General disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Weight gain | Metabolism and nutrition disorders |
| |||
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders |
| |||
| Pruritus/itching | Skin and subcutaneous tissue disorders |
| |||
| Rash/desquamation | Skin and subcutaneous tissue disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders |
| |||
| Gastrointestinal - Other (Specify) | Gastrointestinal disorders |
| |||
| Heartburn/dyspepsia | Gastrointestinal disorders |
| |||
| Incontinence, anal | Gastrointestinal disorders |
| |||
| Mucositis/stomatitis (clinical exam) | Gastrointestinal disorders |
| |||
| Taste alteration (dysgeusia) | Gastrointestinal disorders |
| |||
| Hemorrhage, GI | Gastrointestinal disorders |
| |||
| Hemorrhage, GI | Gastrointestinal disorders |
| |||
| Hemorrhage, GU | Renal and urinary disorders |
| |||
| Hemorrhage, GU | Renal and urinary disorders |
| |||
| Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders |
| |||
| Infection - Other (Specify) | Infections and infestations |
| |||
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
| |||
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
| |||
| Edema: head and neck | General disorders |
| |||
| Edema: limb | General disorders |
| |||
| Edema: trunk/genital | General disorders |
| |||
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations |
| |||
| Albumin, serum-low (hypoalbuminemia) | Investigations |
| |||
| Alkaline phosphatase | Investigations |
| |||
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders |
| |||
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders |
| |||
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders |
| |||
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders |
| |||
| Confusion | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Mood alteration, anxiety | Psychiatric disorders |
| |||
| Neurology - Other | Nervous system disorders |
| |||
| Somnolence/depressed level of consciousness | Nervous system disorders |
| |||
| Tremor | Nervous system disorders |
| |||
| Dry eye syndrome | Eye disorders |
| |||
| Vision-blurred vision | Eye disorders |
| |||
| Pain, back | Musculoskeletal and connective tissue disorders |
| |||
| Pain, bone | Musculoskeletal and connective tissue disorders |
| |||
| Pain, headache | Nervous system disorders |
| |||
| Pain, neck | Musculoskeletal and connective tissue disorders |
| |||
| Pain, pelvis | Musculoskeletal and connective tissue disorders |
| |||
| Pain - Other | General disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary/Upper Respiratory - Other | Respiratory, thoracic and mediastinal disorders |
| |||
| Bladder spasms | Renal and urinary disorders |
| |||
| Renal failure | Renal and urinary disorders |
| |||
| Urinary frequency/urgency | Renal and urinary disorders |
| |||
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders |
| |||
| Syndromes - Other | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Attaphol Pawarode, M.D. | University of Michigan Comprehensive Cancer Center | 734-936-8785 | pawarode@umich.edu |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007952 | Leukemia, Plasma Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
| D007938 | Leukemia |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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