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| Name | Class |
|---|---|
| Blood and Marrow Transplant Group of Georgia | OTHER |
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In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.
In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palonosetron | Experimental | All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV on the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron | Drug | Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting | Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy. | 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission During Acute Phase Post-chemotherapy | Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours) | 24 hours |
| Complete Remission During Overall Chemotherapy Time Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott R Solomon, MD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Palonosetron | All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Palonosetron | All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO |
| 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 | Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting | Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy. | Posted | Number | participants | 120 hours |
|
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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 | Palonosetron | All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distension | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Solomon | Blood and Marrow Transplant Group of Georgia | 404-255-1930 | ssolomon@bmtga.com |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
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|
| ondansetron | Drug | Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV |
|
|
| Dexamethasone | Drug | Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV |
|
|
Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period
| 120 hours |
| Complete Control Rate for Nausea & Vomiting | Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea) | 120 hours |
| Emetic Episodes | Number of emetic episodes | 120 Hours |
| Patients Who Experience First Emetic Episode Within 24 Hours | Number of patients with first emetic episode experienced within 24 hours | 24 hours |
| Number of Patients That Required First Administration of Rescue Medication Within 24 Hours | Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours | 24 hours |
| Number of Patients That Experience Treatment Failure Within the First 24 Hours | Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours | 24 hours |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Complete Remission During Acute Phase Post-chemotherapy | Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours) | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Complete Remission During Overall Chemotherapy Time Period | Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period | Posted | Number | participants | 120 hours |
|
|
|
| Secondary | Complete Control Rate for Nausea & Vomiting | Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea) | Posted | Number | participants | 120 hours |
|
|
|
| Secondary | Emetic Episodes | Number of emetic episodes | Posted | Mean | Full Range | episodes | 120 Hours |
|
|
|
| Secondary | Patients Who Experience First Emetic Episode Within 24 Hours | Number of patients with first emetic episode experienced within 24 hours | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Number of Patients That Required First Administration of Rescue Medication Within 24 Hours | Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | Number of Patients That Experience Treatment Failure Within the First 24 Hours | Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours | Posted | Number | participants | 24 hours |
|
|
|
| 0 |
| 85 |
| 85 |
| 85 |
| abdominal cramping | Gastrointestinal disorders |
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| increased alkaline phosphatase | Hepatobiliary disorders |
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| increased ALT | Hepatobiliary disorders |
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| neutropenia | Blood and lymphatic system disorders |
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| anemia | Blood and lymphatic system disorders |
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| anorexia | Gastrointestinal disorders |
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| anxiety | Psychiatric disorders |
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| increased AST | Hepatobiliary disorders |
|
| abdominal tenderness | Gastrointestinal disorders |
|
| back pain | Musculoskeletal and connective tissue disorders |
|
| rectal bleeding | Gastrointestinal disorders |
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| bruising | Skin and subcutaneous tissue disorders |
|
| chills | Investigations |
|
| constipation | Gastrointestinal disorders |
|
| cough | Respiratory, thoracic and mediastinal disorders |
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| decreased appetite | Gastrointestinal disorders |
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| deconditioning | Investigations |
|
| diarrhea | Gastrointestinal disorders |
|
| dizziness | Nervous system disorders |
|
| dry skin | Skin and subcutaneous tissue disorders |
|
| dry mouth | Gastrointestinal disorders |
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| dysuria | Renal and urinary disorders |
|
| lower extremity edema | Cardiac disorders |
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| fatigue | Investigations |
|
| gastroesophageal reflux disease | Gastrointestinal disorders |
|
| headache | Nervous system disorders |
|
| hiccups | Gastrointestinal disorders |
|
| hyperbilirubinemia | Hepatobiliary disorders |
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| hyperglycemia | Metabolism and nutrition disorders |
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| hypermagnesemia | Metabolism and nutrition disorders |
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| hypernatremia | Metabolism and nutrition disorders |
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| hypertension | Cardiac disorders |
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| hypoalbuminemia | Hepatobiliary disorders |
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| hypocalcemia | Metabolism and nutrition disorders |
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| hypoglycemia | Metabolism and nutrition disorders |
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| hypokalemia | Metabolism and nutrition disorders |
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| hypomagnesemia | Metabolism and nutrition disorders |
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| hyponatremia | Metabolism and nutrition disorders |
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| hypotension | Cardiac disorders |
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| insomnia | Psychiatric disorders |
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| lymphopenia | Blood and lymphatic system disorders |
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| memory changes | Nervous system disorders |
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| mouth pain | Gastrointestinal disorders |
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| mouth sores | Gastrointestinal disorders |
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| mucositis | Gastrointestinal disorders |
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| nausea | Gastrointestinal disorders |
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| neutropenic fever | Infections and infestations |
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| peripheral neuropathy | Nervous system disorders |
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| pruritus | Skin and subcutaneous tissue disorders |
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| rash | Skin and subcutaneous tissue disorders |
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| rhinorrhea | Respiratory, thoracic and mediastinal disorders |
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| shortness of breath with exertion | Respiratory, thoracic and mediastinal disorders |
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| sore throat | Gastrointestinal disorders |
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| tachycardia | Cardiac disorders |
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| taste alteration | Gastrointestinal disorders |
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| throat pain | Gastrointestinal disorders |
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| thrombocytopenia | Blood and lymphatic system disorders |
|
| urinary frequency | Renal and urinary disorders |
|
| vomiting | Gastrointestinal disorders |
|
| leukopenia | Blood and lymphatic system disorders |
|
| generalized weakness | Investigations |
|
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| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |