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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00084170 | Other Identifier | University of Michigan |
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The investigators hypothesize that adding carfilzomib to standard conditioning regimen for allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant relapse and treatment-related mortality by decreasing severe GVHD, leading to overall improvement in transplant outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carfilzomib | Experimental | Carfilzomib will be administered IV over 30 minutes, starting at dose level 1 (20 mg/m2 IV) on Day +1, +2, +6 and +7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib will be administered starting at dose level 1 (20 mg/m2 IV) on day +1, +2, +6 and +7. Dose escalation will be performed on the day +6 and day +7 doses only in each dose level. Day +1 and day+2 doses will be fixed at 20 mg/m2 IV in all dose levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum Tolerated Dose (MTD) of Carfilzomib | Subjects were enrolled on the first dose level (20 mg/m^2), following a standard 3+3 dose escalation. For any given dose level, if none of the 3 subjects developed a treatment-related dose limiting toxicity (DLT), defined per protocol, dose escalation would follow. If a DLT occurred in any given dose level, the cohort would be expanded to 6. Further dose escalation would be made only if DLTs occurred in <2 out of 6 subjects. If >=2 of 6 develop DLTs, dose de-escalation would be made to the previous level. The highest dose level at which no more than one of six participants experience a DLT defines the MTD. | Up to day 28 |
| Phase II: Kaplan-Meier Estimate of the Percentage of Patients Who Are Alive and Have Not Developed Any "Event" | Kaplan-Meier estimate of the percentage of patients who are alive and have not developed relapse/progression of primary disease or clinical grade III-IV acute graft-versus- host disease (GVHD) or chronic GVHD requiring systemic treatment. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Kaplan-Meier Estimate for Progression/Relapse-free Survival Time | Time from day 0 to the date of the first progression/relapse. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Up to 3 years |
| Phase II: Kaplan-Meier Estimate for Overall Survival Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Attaphol Pawarode, M.D. | University of Michgan Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
Two patients who consented never began treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 | Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 1: Participants were administered 20 mg/m^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Phase I: Max Dose 20 mg/m^2 (Day 1-7) |
|
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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 | Aug 24, 2018 |
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|
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| Tacrolimus | Drug | Tacrolimus will be administered at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis. |
|
The time from day 0 to the day of death from any cause. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. |
| Up to 3 years |
| Number of Regimen Related Toxicities (RRTs) | An RTT is defined as an adverse event (AE) that occurs within +37 days after transplant or 30 days after the last dose of carfilzomib (day +7), and is considered to be a direct consequence and a related event as a result of the combination of conditioning chemotherapy, GVHD prophylaxis regimen and carfilzomib. | Up to 30 days post treatment |
| Phase II: Cumulative Incidence of Acute GVHD | The cumulative incidence of acute Graft Versus Host Disease (aGVHD). Events were assigned a severity grade using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0; lower values indicate least severe and higher values indicate most severe. Grades 2 - 4 and grades 3 - 4 events are reported. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | At day 180 post-transplant; data collected up to 3 years |
| Phase II: Cumulative Incidence of Chronic GVHD | The cumulative incidence of chronic Graft Versus Host Disease (GVHD). Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Up to 3 years |
| Phase II: Cumulative Incidence of Non-relapse Mortality | The cumulative incidence of non-relapse mortality. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Up to 3 years |
| FG001 | Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 | Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 2: Participants were administered 27 mg/m^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis. |
| FG002 | Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 | Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 3: Participants were administered 36 mg/m^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis. |
| FG003 | Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 | "Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 4: Participants were administered 45 mg/m^2 of Carfilzomib on days +6 and +7. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis. |
|
| COMPLETED | Completed all 4 doses of Carfilzomib |
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| NOT COMPLETED |
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| Phase I: Max Dose 27 mg/m^2 (Day 1-7) |
|
| Phase I: Max Dose 36 mg/m^2 (Day 1-7) |
|
| Phase I: Max Dose 45 mg/m^2 (Day 1-7) |
|
| Phase II: Max Dose 36 mg/m^2 (Day 1-7) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 | Participants were administered 20 mg/m^2 of Carfilzomib on days 1, 2, 6 and 7. |
| BG001 | Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 | Participants were administered 20 mg/m^2 on days 1 and 2; 27 mg/m^2 of Carfilzomib on days 6 and 7. |
| BG002 | Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 | Participants were administered 20 mg/m^2 on days 1 and 2; 36 mg/m^2 of Carfilzomib on days 6 and 7. |
| BG003 | Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 | Participants were administered 20 mg/m^2 on days 1 and 2; 45 mg/m^2 of Carfilzomib on days 6 and 7. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | 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 | Phase I: Maximum Tolerated Dose (MTD) of Carfilzomib | Subjects were enrolled on the first dose level (20 mg/m^2), following a standard 3+3 dose escalation. For any given dose level, if none of the 3 subjects developed a treatment-related dose limiting toxicity (DLT), defined per protocol, dose escalation would follow. If a DLT occurred in any given dose level, the cohort would be expanded to 6. Further dose escalation would be made only if DLTs occurred in <2 out of 6 subjects. If >=2 of 6 develop DLTs, dose de-escalation would be made to the previous level. The highest dose level at which no more than one of six participants experience a DLT defines the MTD. | Phase 1 study participants | Posted | Number | milligrams per square meter (mg/m^2) | Up to day 28 |
|
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| ||||||||||||||||||||||||||
| Primary | Phase II: Kaplan-Meier Estimate of the Percentage of Patients Who Are Alive and Have Not Developed Any "Event" | Kaplan-Meier estimate of the percentage of patients who are alive and have not developed relapse/progression of primary disease or clinical grade III-IV acute graft-versus- host disease (GVHD) or chronic GVHD requiring systemic treatment. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Subjects who have received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis of the primary outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
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| Secondary | Phase II: Kaplan-Meier Estimate for Progression/Relapse-free Survival Time | Time from day 0 to the date of the first progression/relapse. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Subjects who received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
|
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| Secondary | Phase II: Kaplan-Meier Estimate for Overall Survival Time | The time from day 0 to the day of death from any cause. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Subjects who received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Regimen Related Toxicities (RRTs) | An RTT is defined as an adverse event (AE) that occurs within +37 days after transplant or 30 days after the last dose of carfilzomib (day +7), and is considered to be a direct consequence and a related event as a result of the combination of conditioning chemotherapy, GVHD prophylaxis regimen and carfilzomib. | Subjects who have received at least one dose of carfilzomib were evaluable for toxicities | Posted | Number | Regimen related toxicities | Up to 30 days post treatment |
| ||||||||||||||||||||||||||||
| Secondary | Phase II: Cumulative Incidence of Acute GVHD | The cumulative incidence of acute Graft Versus Host Disease (aGVHD). Events were assigned a severity grade using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0; lower values indicate least severe and higher values indicate most severe. Grades 2 - 4 and grades 3 - 4 events are reported. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Subjects who have received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis of the primary outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At day 180 post-transplant; data collected up to 3 years |
|
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| Secondary | Phase II: Cumulative Incidence of Chronic GVHD | The cumulative incidence of chronic Graft Versus Host Disease (GVHD). Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Subjects who received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
|
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| Secondary | Phase II: Cumulative Incidence of Non-relapse Mortality | The cumulative incidence of non-relapse mortality. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis. | Subjects who received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 3 years |
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Adverse event data were collected up to 100 days after the last dose of carfilzomib. All-cause mortality includes all patients followed for up to three years after their first dose of carfilzomib; total duration of data collection was 6 years with an average duration of 1.8 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 | Dose Level 1 - Maximum Dose Carfilzomib 20 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 1: Participants were administered 20 mg/m^2 of Carfilzomib on days +6 and +7. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Dose Level 2 - Maximum Dose Carfilzomib 27 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 2: Participants were administered 27 mg/m^2 of Carfilzomib on days +6 and +7. | 2 | 3 | 2 | 3 | 0 | 3 |
| EG002 | Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 3: Participants were administered 36 mg/m^2 of Carfilzomib on days +6 and +7. | 18 | 41 | 25 | 41 | 16 | 41 |
| EG003 | Dose Level 4 - Maximum Dose Carfilzomib 45 mg/m^2 IV | Participants in all cohorts were administered 20 mg/m^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Cohort 4: Participants were administered 45 mg/m^2 of Carfilzomib on days +6 and +7. | 2 | 4 | 4 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Colonic hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Corneal ulcer | Eye disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Encephalitis infection | Infections and infestations | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Immune system disorders - Other | Immune system disorders | Systematic Assessment |
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| Infections and infestations - Other | Infections and infestations | Systematic Assessment |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Papulopustular rash | Infections and infestations | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Tumor lysis syndrome | Metabolism and nutrition disorders | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Vascular access complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Creatinine increased | Investigations | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Edema limbs | General disorders | Systematic Assessment |
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| Ejection fraction decreased | Investigations | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Immune system disorders - Other | Immune system disorders | Systematic Assessment |
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| Lung infection | Infections and infestations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Papulopustular rash | Infections and infestations | Systematic Assessment |
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| Penile infection | Infections and infestations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| White blood cell decreased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Attaphol Pawarode, M.D. | University of Michigan Rogel Cancer Center | 734-936-8785 | pawarode@med.umich.edu |
| Oct 23, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D012008 | Recurrence |
| D006086 | Graft vs Host Disease |
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C524865 | carfilzomib |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
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| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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Participants were administered 20 mg/m^2 on days 1 and 2; 45 mg/m^2 of Carfilzomib on days 6 and 7. |
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