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| ID | Type | Description | Link |
|---|---|---|---|
| CLBH589DUS97T | Other Identifier | Novartis Pharmaceuticals |
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The purpose of this study is to learn more about ways to prevent or delay relapse of multiple myeloma (MM). This study will determine the best dosing schedule of LBH589 maintenance therapy as well as the safety (side effects) and tolerability of LBH589 maintenance therapy after autologous hematopoietic cell transplant (HCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Maintenance Therapy | Active Comparator | Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. |
|
| Cohort B: Maintenance Therapy | Active Comparator | Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat | Drug | Maintenance therapy dosing as outlined in Cohorts A and B. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Dose Intensity (RDI) Per Cohort | Investigators will calculate RDI for each cohort. Relative dose intensity (RDI) represents the ratio of the amount of a drug actually delivered [actual dose intensity (DI)] to the amount planned (planned DI). The purpose of calculating RDI is to evaluate whether the planned DI of a chemotherapy treatment was actually achieved which may suggest the feasibility of planned treatment regimen. There are multitude of reports demonstrating a correlation between RDI and survival in cancer treatment. RDI = (total dose received by the patient = mg)/(planned full dose of drug = mg). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Complete Response (CR) rate to panobinostat maintenance therapy after autologous HCT. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow. | Up to 5 years |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taiga Nishihori, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Maintenance Therapy | Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B. |
| FG001 | Cohort B: Maintenance Therapy | Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Maintenance Therapy | Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B. |
| BG001 | Cohort B: Maintenance Therapy |
| 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 | Relative Dose Intensity (RDI) Per Cohort | Investigators will calculate RDI for each cohort. Relative dose intensity (RDI) represents the ratio of the amount of a drug actually delivered [actual dose intensity (DI)] to the amount planned (planned DI). The purpose of calculating RDI is to evaluate whether the planned DI of a chemotherapy treatment was actually achieved which may suggest the feasibility of planned treatment regimen. There are multitude of reports demonstrating a correlation between RDI and survival in cancer treatment. RDI = (total dose received by the patient = mg)/(planned full dose of drug = mg). | Posted | Median | Full Range | percentage of dose | Up to 2 years |
|
Adverse events collected from date of consent until off study date, 4 years, 2 months.
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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 | Cohort A: Maintenance Therapy | Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiga Nishihori, MD | Moffitt Cancer Center | 813-745-8156 | Taiga.Nishihori@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2017 | Jun 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Progressive Disease (PD) according to Uniform Response Reporting Criteria for Multiple Myeloma by the International Myeloma Working Group (IMWG). Increase of 25% from lowest response value in any of the following:
|
| at 2 years |
| Overall Survival (OS) | OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. | at 2 years |
Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cohort B: Maintenance Therapy | Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B. |
|
|
| Secondary | Complete Response Rate | Complete Response (CR) rate to panobinostat maintenance therapy after autologous HCT. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow. | Posted | Number | 95% Confidence Interval | percentage | Up to 5 years |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progressive Disease (PD) according to Uniform Response Reporting Criteria for Multiple Myeloma by the International Myeloma Working Group (IMWG). Increase of 25% from lowest response value in any of the following:
| Posted | Median | 95% Confidence Interval | percentage of participants | at 2 years |
|
|
|
| Secondary | Overall Survival (OS) | OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. | Posted | Median | 95% Confidence Interval | percentage of participants | at 2 years |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| 10 |
| 15 |
| EG001 | Cohort B: Maintenance Therapy | Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B. | 0 | 15 | 3 | 15 | 11 | 15 |
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Polyuria and nocturia | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorders -Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | bilateral femoral rod placement procedure |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cholecystectomy | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Atrial fibrilation | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fibromyalgia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ottis externa | Ear and labyrinth disorders | CTCAE (4.0) | 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 |
| D006880 |
| Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |