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])
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])