ID

36421

Beschrijving

Carfilzomib/Cyclophosphamide/Dexamethasone With Maintenance Carfilzomib in Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02315716

Link

https://clinicaltrials.gov/show/NCT02315716

Trefwoorden

Versies (1)
  1. 14-05-19 14-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

14 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02315716

Engels

Eligibility Multiple Myeloma NCT02315716

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. life expectancy ≥ 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
3. eastern cooperative oncology group (ecog) performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
4. previously untreated patients with symptomatic mm (see appendix 3)
Beschrijving

Patients Untreated | Multiple Myeloma Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0231220
5. measurable disease as defined by one of the following:
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
secretory myeloma: monoclonal protein in the serum ≥10g/l or monoclonal light chain in the urine (bence jones protein ≥200mg/24hours), or serum free light chain (sflc, involved light chain ≥100mg/l provided the flc ratio is abnormal)
Beschrijving

Multiple Myeloma secretory | Serum Monoclonal Protein Measurement | Monoclonal free light chain present In Urine | Bence Jones Protein In Urine Measurement | Serum Free Light Chain Measurement | Serum Free Light Chain Ratio Abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1327616
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C2984963
UMLS CUI [3,1]
C1532998
UMLS CUI [3,2]
C0042037
UMLS CUI [4,1]
C0004965
UMLS CUI [4,2]
C0042037
UMLS CUI [4,3]
C0242485
UMLS CUI [5,1]
C2827352
UMLS CUI [5,2]
C0242485
UMLS CUI [6]
C2826181
non-secretory myeloma: ≥ 30% plasma cells in the marrow (aspirate and/or biopsy) and at least one plasmacytoma ≥2 cm as determined by clinical examination or applicable radiographs (i.e., mri or ct scan)
Beschrijving

Non-secretory myeloma | Plasma Cells Percentage Bone Marrow | Marrow aspirate | Bone marrow biopsy | Plasmacytoma Size Quantity | Clinical examination | Radiography | MRI scan | CT scan

Datatype

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2,1]
C0032112
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0005953
UMLS CUI [3]
C0857285
UMLS CUI [4]
C0005954
UMLS CUI [5,1]
C0032131
UMLS CUI [5,2]
C0456389
UMLS CUI [5,3]
C1265611
UMLS CUI [6]
C1456356
UMLS CUI [7]
C0034571
UMLS CUI [8]
C0024485
UMLS CUI [9]
C0040405
6. suitable for high dose therapy and asct
Beschrijving

Patients Appropriate Therapeutic procedure High dose | Patients Appropriate Transplantation of autologous hematopoietic stem cell

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0444956
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1831743
7. adequate hepatic function, with serum alt ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dl (34 µmol/l) within 14 days prior to randomisation
Beschrijving

Liver function | Alanine aminotransferase measurement | Bilirubin, direct measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201916
8. absolute neutrophil count (anc) ≥ 1.0 × 109/l within 14 days prior to randomisation
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
9. hemoglobin ≥ 8 g/dl (80 g/l) within 14 days prior to randomisation (subjects may be receiving red blood cell [rbc] transfusions in accordance with institutional guidelines)
Beschrijving

Hemoglobin measurement | Red Blood Cell Transfusion allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2,1]
C0086252
UMLS CUI [2,2]
C0683607
10. platelet count ≥ 75 × 109/l (≥ 50 × 109/l if myeloma involvement in the bone marrow is > 50%) within 14 days prior to randomisation
Beschrijving

Platelet Count measurement | Bone Marrow Percentage Involvement with Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0026764
11. creatinine clearance (crcl) ≥ 30 ml/minute within 7 days prior to randomisation, either measured or calculated using a standard formula (eg, cockcroft and gault)
Beschrijving

Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C2711451
12. written informed consent in accordance with local and institutional guidelines.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
13. females of childbearing potential (fcbp) must agree to ongoing pregnancy testing and to practice contraception.
Beschrijving

Childbearing Potential Pregnancy Tests | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
14. male subjects must agree to practice contraception.
Beschrijving

Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating females
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. major surgery within 21 days prior to randomisation
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
3. acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomisation
Beschrijving

Communicable Disease Treatment required for | Antibiotics for systemic use | Antiviral Agents | Antifungal Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C3540704
UMLS CUI [3]
C0003451
UMLS CUI [4]
C0003308
4. known human immunodeficiency virus infection
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
5. active hepatitis b or c infection
Beschrijving

Hepatitis B | Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
6. unstable angina or myocardial infarction within 4 months prior to randomisation, nyha class iii or iv heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker
Beschrijving

Angina, Unstable | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Coronary Artery Disease Severe | Ventricular arrhythmia Severe Uncontrolled | Sick Sinus Syndrome | Ischemia Electrocardiography | Abnormal cardiac conduction CTCAE Grades | Exception Artificial cardiac pacemaker Present

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C1956346
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0085612
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0205318
UMLS CUI [7]
C0037052
UMLS CUI [8,1]
C0022116
UMLS CUI [8,2]
C1623258
UMLS CUI [9,1]
C0232219
UMLS CUI [9,2]
C1516728
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0030163
UMLS CUI [10,3]
C0150312
7. uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomisation
Beschrijving

Uncontrolled hypertension | Diabetic - poor control

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421258
8. non-haematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
Beschrijving

Malignant Neoplasms | Exception Hematologic Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Thyroid carcinoma Treated | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Prostate carcinoma Gleason Grading System | Exception PSA Level Stable | Exception Malignant Neoplasm Cured Excision | Exception Impact Life Expectancy Unlikely | Exception Transitional cell carcinoma of bladder Localized | Exception Benign neoplasm of adrenal gland | Exception Benign tumor of pancreas

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0376545
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0549473
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0686288
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0600139
UMLS CUI [8,3]
C0332326
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C4086720
UMLS CUI [9,3]
C0205360
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0006826
UMLS CUI [10,3]
C1880198
UMLS CUI [10,4]
C0728940
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C4049986
UMLS CUI [11,3]
C0023671
UMLS CUI [11,4]
C0750558
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0279680
UMLS CUI [12,3]
C0392752
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0154040
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0347284
9. significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to randomisation
Beschrijving

Neuropathy CTCAE Grades | Pain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0030193
10. known history of allergy to captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
Beschrijving

Hypersensitivity Sulfobutylether-beta-cyclodextrin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0296727
11. contraindication to any of the required concomitant drugs or supportive treatments, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
Beschrijving

Medical contraindication Investigational New Drugs | Medical contraindication Investigational Therapy | Medical contraindication Antiviral Agents | Intolerance Hydration | Etiology Impairment pulmonary | Etiology Impairment cardiac

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0949266
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0003451
UMLS CUI [4,1]
C0231199
UMLS CUI [4,2]
C4520800
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0221099
UMLS CUI [5,3]
C0024109
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0221099
UMLS CUI [6,3]
C0018787
12. subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomisation
Beschrijving

Pleural effusion Requirement Thoracentesis | Ascites Requirement Paracentesis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0189477
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0034115
13. any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Beschrijving

Disease Interferes with Protocol Compliance | Medical condition Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Medical condition Interferes with Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
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Similar models

Eligibility Multiple Myeloma NCT02315716

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
2. life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
3. eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Patients Untreated | Multiple Myeloma Symptomatic
Item
4. previously untreated patients with symptomatic mm (see appendix 3)
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Measurable Disease
Item
5. measurable disease as defined by one of the following:
boolean
C1513041 (UMLS CUI [1])
Multiple Myeloma secretory | Serum Monoclonal Protein Measurement | Monoclonal free light chain present In Urine | Bence Jones Protein In Urine Measurement | Serum Free Light Chain Measurement | Serum Free Light Chain Ratio Abnormal
Item
secretory myeloma: monoclonal protein in the serum ≥10g/l or monoclonal light chain in the urine (bence jones protein ≥200mg/24hours), or serum free light chain (sflc, involved light chain ≥100mg/l provided the flc ratio is abnormal)
boolean
C0026764 (UMLS CUI [1,1])
C1327616 (UMLS CUI [1,2])
C0229671 (UMLS CUI [2,1])
C2984963 (UMLS CUI [2,2])
C1532998 (UMLS CUI [3,1])
C0042037 (UMLS CUI [3,2])
C0004965 (UMLS CUI [4,1])
C0042037 (UMLS CUI [4,2])
C0242485 (UMLS CUI [4,3])
C2827352 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
C2826181 (UMLS CUI [6])
Non-secretory myeloma | Plasma Cells Percentage Bone Marrow | Marrow aspirate | Bone marrow biopsy | Plasmacytoma Size Quantity | Clinical examination | Radiography | MRI scan | CT scan
Item
non-secretory myeloma: ≥ 30% plasma cells in the marrow (aspirate and/or biopsy) and at least one plasmacytoma ≥2 cm as determined by clinical examination or applicable radiographs (i.e., mri or ct scan)
boolean
C0456845 (UMLS CUI [1])
C0032112 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0857285 (UMLS CUI [3])
C0005954 (UMLS CUI [4])
C0032131 (UMLS CUI [5,1])
C0456389 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C1456356 (UMLS CUI [6])
C0034571 (UMLS CUI [7])
C0024485 (UMLS CUI [8])
C0040405 (UMLS CUI [9])
Patients Appropriate Therapeutic procedure High dose | Patients Appropriate Transplantation of autologous hematopoietic stem cell
Item
6. suitable for high dose therapy and asct
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0444956 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1831743 (UMLS CUI [2,3])
Liver function | Alanine aminotransferase measurement | Bilirubin, direct measurement
Item
7. adequate hepatic function, with serum alt ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dl (34 µmol/l) within 14 days prior to randomisation
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
Absolute neutrophil count
Item
8. absolute neutrophil count (anc) ≥ 1.0 × 109/l within 14 days prior to randomisation
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement | Red Blood Cell Transfusion allowed
Item
9. hemoglobin ≥ 8 g/dl (80 g/l) within 14 days prior to randomisation (subjects may be receiving red blood cell [rbc] transfusions in accordance with institutional guidelines)
boolean
C0518015 (UMLS CUI [1])
C0086252 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Platelet Count measurement | Bone Marrow Percentage Involvement with Myeloma
Item
10. platelet count ≥ 75 × 109/l (≥ 50 × 109/l if myeloma involvement in the bone marrow is > 50%) within 14 days prior to randomisation
boolean
C0032181 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0026764 (UMLS CUI [2,4])
Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
11. creatinine clearance (crcl) ≥ 30 ml/minute within 7 days prior to randomisation, either measured or calculated using a standard formula (eg, cockcroft and gault)
boolean
C0373595 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Informed Consent
Item
12. written informed consent in accordance with local and institutional guidelines.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy Tests | Childbearing Potential Contraceptive methods
Item
13. females of childbearing potential (fcbp) must agree to ongoing pregnancy testing and to practice contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Gender Contraceptive methods
Item
14. male subjects must agree to practice contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Major surgery
Item
2. major surgery within 21 days prior to randomisation
boolean
C0679637 (UMLS CUI [1])
Communicable Disease Treatment required for | Antibiotics for systemic use | Antiviral Agents | Antifungal Agents
Item
3. acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomisation
boolean
C0009450 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C3540704 (UMLS CUI [2])
C0003451 (UMLS CUI [3])
C0003308 (UMLS CUI [4])
HIV Infection
Item
4. known human immunodeficiency virus infection
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
5. active hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Angina, Unstable | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Coronary Artery Disease Severe | Ventricular arrhythmia Severe Uncontrolled | Sick Sinus Syndrome | Ischemia Electrocardiography | Abnormal cardiac conduction CTCAE Grades | Exception Artificial cardiac pacemaker Present
Item
6. unstable angina or myocardial infarction within 4 months prior to randomisation, nyha class iii or iv heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities unless subject has a pacemaker
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002962 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1956346 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0085612 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
C0037052 (UMLS CUI [7])
C0022116 (UMLS CUI [8,1])
C1623258 (UMLS CUI [8,2])
C0232219 (UMLS CUI [9,1])
C1516728 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0030163 (UMLS CUI [10,2])
C0150312 (UMLS CUI [10,3])
Uncontrolled hypertension | Diabetic - poor control
Item
7. uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomisation
boolean
C1868885 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
Malignant Neoplasms | Exception Hematologic Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Thyroid carcinoma Treated | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Prostate carcinoma Gleason Grading System | Exception PSA Level Stable | Exception Malignant Neoplasm Cured Excision | Exception Impact Life Expectancy Unlikely | Exception Transitional cell carcinoma of bladder Localized | Exception Benign neoplasm of adrenal gland | Exception Benign tumor of pancreas
Item
8. non-haematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0376545 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0549473 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0686288 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0600139 (UMLS CUI [8,2])
C0332326 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C4086720 (UMLS CUI [9,2])
C0205360 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0006826 (UMLS CUI [10,2])
C1880198 (UMLS CUI [10,3])
C0728940 (UMLS CUI [10,4])
C1705847 (UMLS CUI [11,1])
C4049986 (UMLS CUI [11,2])
C0023671 (UMLS CUI [11,3])
C0750558 (UMLS CUI [11,4])
C1705847 (UMLS CUI [12,1])
C0279680 (UMLS CUI [12,2])
C0392752 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0154040 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0347284 (UMLS CUI [14,2])
Neuropathy CTCAE Grades | Pain
Item
9. significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to randomisation
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Hypersensitivity Sulfobutylether-beta-cyclodextrin
Item
10. known history of allergy to captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
boolean
C0020517 (UMLS CUI [1,1])
C0296727 (UMLS CUI [1,2])
Medical contraindication Investigational New Drugs | Medical contraindication Investigational Therapy | Medical contraindication Antiviral Agents | Intolerance Hydration | Etiology Impairment pulmonary | Etiology Impairment cardiac
Item
11. contraindication to any of the required concomitant drugs or supportive treatments, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0003451 (UMLS CUI [3,2])
C0231199 (UMLS CUI [4,1])
C4520800 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0221099 (UMLS CUI [5,2])
C0024109 (UMLS CUI [5,3])
C0015127 (UMLS CUI [6,1])
C0221099 (UMLS CUI [6,2])
C0018787 (UMLS CUI [6,3])
Pleural effusion Requirement Thoracentesis | Ascites Requirement Paracentesis
Item
12. subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomisation
boolean
C0032227 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0189477 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0034115 (UMLS CUI [2,3])
Disease Interferes with Protocol Compliance | Medical condition Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Medical condition Interferes with Informed Consent
Item
13. any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
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