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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01699 | Registry Identifier | NCI-CTRP | |
| PT-171-502 | Other Identifier | Onyx Protocol | |
| 09-004091 | Other Identifier | Mayo Clinic IRB | |
| MC0982 | Other Identifier | Mayo Clinic Cancer Center |
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RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients with newly diagnosed active multiple myeloma.
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. (Phase I) II. In newly diagnosed myeloma to evaluate the response rate (CR, nCR, and VGPR) to carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone after four 28 day cycles. (Phase II)
SECONDARY OBJECTIVES:
I. Determine the overall response rate (CR, nCR, PR) after 4, 8, 12 cycles. II. Determine the duration of progression-free and overall survival for patients receiving this regimen.
III. To evaluate the incidence of toxicities for this regimen. IV. To evaluate the ability to successfully collect peripheral blood stem cells following four months of combination therapy.
OUTLINE: This is a phase I, dose escalation study of carfilzomib followed by a phase II study.
Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3 months, then every 3 months for 1 year, and then every 6 months for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carfilzomib | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (Phase I) | To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs | From baseline to end of active treatment, up to 12 28-day cycles. |
| Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II) | The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients. A complete response is defined as:
A very good partial response is defined as:
| Following the first 4 cycles of treatment (28 day cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (Phase II) | PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: • Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas • Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Joseph R. Mikhael, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: Dose Level -1 | Patients receive: Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cyclophosphamide |
| Drug |
Given orally |
|
|
| thalidomide | Drug | Given orally |
|
|
| dexamethasone | Drug | Given orally |
|
|
| From baseline to progression or death up to 3 years |
| Time to Treatment Failure | The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier | From baseline to end of active treatment |
| Stem Cell Collection and Engraftment (Phase II) | For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported. | Following the first 4 courses of treatment |
| Complete Response (Phase II) | In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy. | Following the first 4 courses of treatment |
| Survival Time (Phase II) | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier | From baseline to death |
| Progression Free Survival (12 Month) | Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark. | 12 months |
| Progession Free Survival (24 Month) | Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark. | 24 months |
| Overall Survival (12 Month) | 12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months. | From baseline to death |
| Overall Survival (24 Month) | 24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months. | From baseline to death |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-6350 | United States |
| FG001 |
| Phase I: Dose Level 0 |
Patients receive: Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles. |
| FG002 | Phase I: Dose Level 1 | Patients receive: Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles. |
| FG003 | Phase I: Dose Level 2 | Patients receive: Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles. |
| FG004 | Phase II: Dose Level 0 | Patients receive: Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles. |
| FG005 | Phase II: Dose Level 1 | Patients receive: Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles. |
| COMPLETED |
|
| NOT COMPLETED |
|
All patients that were eligible and treated for the study were evaluated.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treated Patients | Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. |
| 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 |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Maximum Tolerated Dose (Phase I) | To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2. We are reporting the number of DLTs | All patients registered to a dose escalation Phase I group were analyzed for this endpoint. | Posted | Number | participants | From baseline to end of active treatment, up to 12 28-day cycles. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II) | The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients. A complete response is defined as:
A very good partial response is defined as:
| All enrolled patients who began treatment were evaluated for safety and response. | Posted | Number | percentage of participants | Following the first 4 cycles of treatment (28 day cycles) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (Phase II) | PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following: • Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas • Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder | All of the 64 participants that were eligible and began treatment were evaluated. | Posted | Number | 95% Confidence Interval | months | From baseline to progression or death up to 3 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier | All enrolled patients who began treatment were evaluated for safety and response. | Posted | Number | 95% Confidence Interval | months | From baseline to end of active treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stem Cell Collection and Engraftment (Phase II) | For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported. | Of the 64 patients that began protocol treatment, stem cell harvesting was attempted on 42 patients. | Posted | Number | participants | Following the first 4 courses of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response (Phase II) | In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy. | Posted | Number | participants | Following the first 4 courses of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Survival Time (Phase II) | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier | Posted | Median | 95% Confidence Interval | months | From baseline to death |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (12 Month) | Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark. | All of the 64 participants that were eligible and began treatment were evaluated. | Posted | Number | 95% Confidence Interval | percentage of participants at 12 months | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progession Free Survival (24 Month) | Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark. | All of the 64 participants that were eligible and began treatment were evaluated. | Posted | Number | 95% Confidence Interval | percentage of participants at 24 months | 24 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (12 Month) | 12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months. | All of the 64 participants that were eligible and began treatment were evaluated. | Posted | Number | 95% Confidence Interval | percentage of patients | From baseline to death |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (24 Month) | 24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months. | All of the 64 participants that were eligible and began treatment were evaluated. | Posted | Number | 95% Confidence Interval | percentage of patients | From baseline to death |
|
|
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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 | All Treated Patients | Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28. | 30 | 64 | 64 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Immune system disorders - Other, specify | Immune system disorders | MedDRA 12 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | MedDRA 12 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Paroxysmal atrial tachycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 12 | Systematic Assessment |
| |
| Floaters | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Edema trunk | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 12 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA 12 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 12 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Genital edema | Reproductive system and breast disorders | MedDRA 12 | Systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Riad Mikhael, M.D. | Mayo Clinic | Mikhael.Joseph@mayo.edu |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C524865 | carfilzomib |
| D003520 | Cyclophosphamide |
| D013792 | Thalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| OG003 | Dose Level 2 | Patients receive: Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28. Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles. |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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