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| ID | Type | Description | Link |
|---|---|---|---|
| Millennium | Other Identifier | X05397 |
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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
| Duke Cancer Institute | OTHER |
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The primary purpose of this study is to estimate the overall response rate (ORR), defined as partial response (PR) or better at any time during induction therapy. The success of the therapy will be determined by ORR with strong consideration given to the secondary endpoints of tolerability, duration of response, and quality of life (QOL).
All patients will be treated with the same experimental regimen. Several novel features are being explored: the substitution of cyclophosphamide for melphalan; once weekly AND subcutaneous bortezomib instead of standard twice weekly, intravenous dosing; and alternating bortezomib and lenalidomide in maintenance.
The investigators hypothesize that this regimen will prove to be tolerable and effective in inducing and maintaining remission in a patient population that is historically very difficult to treat, namely Multiple Myeloma (MM) patients who are too elderly or suffer comorbidities, such as renal insufficiency, that otherwise complicate aggressive therapies like autologous stem-cell transplantation (ASCT). In short, the investigators view this as the "Multiple Myeloma trial for non-trial candidates."
A total of 35 patients will be accrued to this single arm, open label, phase II trial over a period of about 18 months, studying induction chemotherapy with VELCADE, cyclophosphamide and dexamethasone administered on an attenuated dosing schedule to accommodate non-candidates for high-dose chemotherapy with autologous stem cell transplantation - an often frail patient population. Maintenance therapy will follow with alternating lenalidomide and VELCADE. All patients should receive antiviral (zoster) prophylaxis, and peptic ulcer prophylaxis is recommended. Aspirin and/or anticoagulation are left to study physician discretion. All patients will be treated with the same experimental regimen. Several novel features are being explored: the substitution of cyclophosphamide for melphalan; once weekly AND subcutaneous bortezomib instead of standard twice weekly, intravenous dosing; and alternating bortezomib and lenalidomide in maintenance. The overarching aim is to preserve efficacy while minimizing toxicity and inconvenience to this often frail patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velcade, cyclophosphamide, Revlimid | Experimental | INDUCTION (28-day cycles for 8 cycles):
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velcade | Drug | Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until disease progression, lack of tolerability, or death. Patients who cannot tolerate SC VELCADE will be converted to the same dose, given intravenously (IV), per discretion of the treating physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) During Induction Therapy | Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria: IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. | Up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Adverse Event Rate | Defined as number of patients experiencing any grade or severe (≥ grade 3 by common toxicity criteria for adverse events (CTCAE) v4.0 criteria) adverse events at any time during the study | Up to 3 years |
| Maximum Depth of Response During Induction Therapy |
Not provided
Inclusion Criteria:
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Age ≥18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Multiple Myeloma (MM) diagnosed according to the following standard criteria (all three criteria must be met):
Measurable disease requiring systemic therapy.
No prior systemic therapy or radiation therapy active against myeloma lasting more than four weeks duration. Any prior therapy must be completed a minimum of 21 days before starting study drugs. Enrollment of subjects who require radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.
Karnofsky performance status (KPS) of ≥ 60% at study entry.
In order to obtain lenalidomide, patients must be registered into the mandatory RevlimidREMS® program during the maintenance phase of therapy, and be willing and able to comply with the requirements of RevlimidREMS®
Female subjects must be postmenopausal for at least 1 year before the screening visit or surgically sterilized. If females are of childbearing potential, they must adhere to required pregnancy testing; male and female subjects must use specified effective birth control methods.
Patients should receive concomitant therapy with bisphosphonates, regardless of the presence of bony lesions, although study physicians may use their discretion based on presence of renal insufficiency or other mitigating factors.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwynn Long, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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17 subjects consented to the study. 1 subject was a screen failure.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Velcade, Cyclophosphamide, Revlimid | INDUCTION (28-day cycles for 8 cycles):
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Velcade, Cyclophosphamide, Revlimid | INDUCTION (28-day cycles for 8 cycles):
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Response Rate (ORR) During Induction Therapy | Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria: IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. | Posted | Number | percentage of participants | Up to 8 months |
|
1st day of drug till 30 days after last dose
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Velcade, Cyclophosphamide, Revlimid | INDUCTION (28-day cycles for 8 cycles):
MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):
Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI CTCAE v4 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gwynn Long | Duke University Medical Center | 919-668-0838 | gwynn.long@duke.edu |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003520 | Cyclophosphamide |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Cyclophosphamide | Drug | Cyclophosphamide: 300 mg/m2, given orally on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Patients who cannot swallow cyclophosphamide pills will be converted to the same dose, given intravenously (IV). |
|
| Revlimid | Drug | Lenalidomide (odd cycles [9,11,13, etc.]: 10 mg, given orally on days 1-21. Maintenance cycles will last 28 days and continue indefinitely, until disease progression, lack of tolerability, or death. On even cycles, patients will be prescribed enough lenalidomide to take at home, as instructed, for one cycle. This will be prescribed through the mandatory RevlimidREMS® program. If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up. Patients who take more than the prescribed dose of lenalidomide should be instructed to seek emergency medical care if needed and contact study staff immediately. |
|
|
Maximum depth of response is defined as: ranging from partial response to complete response by International Myeloma Working Group (IMWG). Described as number of patients achieving each level of response. IMWG: CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease. |
| Up to 8 months |
| Maximum Depth of Response During Maintenance Therapy | Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy. IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease. | Up to 3 years |
| Median Time to Response | Defined as median time to achievement of response (partial remission or better by International Myeloma Working Group standard criteria), in study subjects during 8 months of induction chemotherapy. | Up to 8 months |
| Median Duration of Response | Defined as median time elapsed in study subjects between achievement of response and disease progression. | From date of first confirmed response until date of disease progression or up to 3 years |
| Median Progression-free Survival | Defined as median time elapsed in study subjects between initiation of study therapy and either disease progression or death, regardless of cause of death. | 4 years |
| Median Overall Survival | Defined as median time elapsed in study subjects between initiation of study therapy and death, regardless of cause. | Up to 3 years |
| QLQ-C30 Question 29 | Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 29: how would you rate your overall health during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality. | baseline, 3 months, 5 months |
| QLQ-C30 Question 30 | Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality. | baseline, 3 months, 5 months |
| Functionality as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool | Mean functionality in study subjects, quantitatively scored using the standardized and validated Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool, which comprehensively assesses aspects of a patient's functionality such as symptoms (e.g., pain, anxiety), social support (e.g., someone to turn to for help), and ability to carry out routine activities (e.g., grocery shopping) or physical exertion (e.g., climbing stairs) was assessed at baseline. The score is obtained by inserting patient-specific data into the online calculator found at http://www.mycarg.org/Chemo\_Toxicity\_Calculator, which is based on the risk score described in Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011;29(25):3457-3465. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk for severe (grade >2) toxicity. | baseline |
| Risk Score as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool | Calculation of the risk score requires that the patient be assessed with the CALGB Assessment Tool, which has both a patient self-reporting questionnaire and a clinician assessment. Both will be used in this trial, and thus patients will have risk scores based on their own self-assessments and risk scores based on the clinicians' assessment. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk. The distribution of the risk score in this trial will be described by plotting the median of the risk score against time, with patient and clinician assessments overlaid on the same plot. | Day 1 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Severe Adverse Event Rate | Defined as number of patients experiencing any grade or severe (≥ grade 3 by common toxicity criteria for adverse events (CTCAE) v4.0 criteria) adverse events at any time during the study | Posted | Number | percentage of participants | Up to 3 years |
|
|
|
| Secondary | Maximum Depth of Response During Induction Therapy | Maximum depth of response is defined as: ranging from partial response to complete response by International Myeloma Working Group (IMWG). Described as number of patients achieving each level of response. IMWG: CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease. | Posted | Number | percentage of participants | Up to 8 months |
|
|
|
| Secondary | Maximum Depth of Response During Maintenance Therapy | Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy. IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease. | 8 of all subjects reached maintenance and could be analyzed | Posted | Number | percentage of participants | Up to 3 years |
|
|
|
| Secondary | Median Time to Response | Defined as median time to achievement of response (partial remission or better by International Myeloma Working Group standard criteria), in study subjects during 8 months of induction chemotherapy. | Posted | Median | Standard Deviation | months | Up to 8 months |
|
|
|
| Secondary | Median Duration of Response | Defined as median time elapsed in study subjects between achievement of response and disease progression. | 9 out of all patients achieved response and hence could be analyzed for duration of response | Posted | Median | Standard Deviation | months | From date of first confirmed response until date of disease progression or up to 3 years |
|
|
|
| Secondary | Median Progression-free Survival | Defined as median time elapsed in study subjects between initiation of study therapy and either disease progression or death, regardless of cause of death. | Posted | Median | Standard Deviation | months | 4 years |
|
|
|
| Secondary | Median Overall Survival | Defined as median time elapsed in study subjects between initiation of study therapy and death, regardless of cause. | Posted | Median | Standard Deviation | months | Up to 3 years |
|
|
|
| Secondary | QLQ-C30 Question 29 | Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 29: how would you rate your overall health during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality. | Participants who completed questionnaire. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months, 5 months |
|
|
|
|
| Secondary | QLQ-C30 Question 30 | Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality. | Participants who completed questionnaire. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months, 5 months |
|
|
|
|
| Secondary | Functionality as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool | Mean functionality in study subjects, quantitatively scored using the standardized and validated Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool, which comprehensively assesses aspects of a patient's functionality such as symptoms (e.g., pain, anxiety), social support (e.g., someone to turn to for help), and ability to carry out routine activities (e.g., grocery shopping) or physical exertion (e.g., climbing stairs) was assessed at baseline. The score is obtained by inserting patient-specific data into the online calculator found at http://www.mycarg.org/Chemo\_Toxicity\_Calculator, which is based on the risk score described in Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011;29(25):3457-3465. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk for severe (grade >2) toxicity. | Participants who completed functionality assessment at baseline. Data were incompletely and irregularly collected after baseline so unable to analyze additional time points. | Posted | Mean | Standard Deviation | Scores on a scale | baseline |
|
|
|
| Secondary | Risk Score as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool | Calculation of the risk score requires that the patient be assessed with the CALGB Assessment Tool, which has both a patient self-reporting questionnaire and a clinician assessment. Both will be used in this trial, and thus patients will have risk scores based on their own self-assessments and risk scores based on the clinicians' assessment. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk. The distribution of the risk score in this trial will be described by plotting the median of the risk score against time, with patient and clinician assessments overlaid on the same plot. | Data for the risk score wasn't recorded correctly, and therefore we were unable to analyze the data. | Posted | Day 1 |
|
|
| 9 |
| 14 |
| 14 |
| 14 |
| Infections and infestations - Other, specify | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | NCI CTCAE v4 | Non-systematic Assessment |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Chills | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Edema limbs | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Fatigue | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Fever | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Malaise | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Pain | General disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Immune system disorders - Other, specify | Immune system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Bronchial infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | NCI CTCAE v4 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | NCI CTCAE v4 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Creatinine increased | Investigations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | NCI CTCAE v4 | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | NCI CTCAE v4 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Psychiatric disorders - Other, specify | Psychiatric disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Bullous dermatitis | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Nail loss | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | NCI CTCAE v4 | Non-systematic Assessment |
|
Not provided
Not provided
| 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 |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| Complete Response/Stringent complete response |
|
| Progressive Disease/no response |
|
| Title | Measurements |
|---|---|
|
| Complete Response/Stringent complete response |
|
| Progressive Disease/no response |
|
| Title | Measurements |
|---|---|
|
| 0.19 |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Superiority or Other |