Information:
Error:
ID
18140
Description
UARK 2003-33, Total Therapy III; ODM derived from: https://clinicaltrials.gov/show/NCT00081939
Link
https://clinicaltrials.gov/show/NCT00081939
Keywords
Versions (1)
- 10/23/16 10/23/16 -
Uploaded on
October 23, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00081939
Eligibility Multiple Myeloma NCT00081939
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Myeloma NCT00081939
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Multiple Myeloma Requirement Therapeutic procedure | Smoldering myeloma | Progressive Disease Evidence Requirement Chemotherapy
Item
patients must have newly diagnosed active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
boolean
C0026764 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1531608 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C1531608 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
Proteins criteria | M component Immunoglobulin G | M component Immunoglobulin A | M component Immunoglobulin D | M component Immunoglobulin E | Immunoglobulin kappa-Chains urinary | Immunoglobulin lambda-Chains urinary | Bence Jones Protein | Response Evaluation | Plasmacytosis Percentage | Multiple solitary plasmacytomas Focal | Magnetic Resonance Imaging | Hematopoietic Cell Growth Factors Absence
Item
protein criteria must be present (quantifiable m-component of igg, iga, igd, or ige and/or urinary kappa or lambda light chain or bence jones protein) in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas on mri or diffuse hyperintense signal on stir images in the absence of hematopoietic growth factors.
boolean
C0033684 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2363751 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C2363751 (UMLS CUI [3,1])
C0020835 (UMLS CUI [3,2])
C2363751 (UMLS CUI [4,1])
C0020843 (UMLS CUI [4,2])
C2363751 (UMLS CUI [5,1])
C0020846 (UMLS CUI [5,2])
C0021036 (UMLS CUI [6,1])
C1524119 (UMLS CUI [6,2])
C0021037 (UMLS CUI [7,1])
C1524119 (UMLS CUI [7,2])
C0004965 (UMLS CUI [8])
C1704632 (UMLS CUI [9,1])
C1261322 (UMLS CUI [9,2])
C0085663 (UMLS CUI [10,1])
C0439165 (UMLS CUI [10,2])
C1533062 (UMLS CUI [11,1])
C0205234 (UMLS CUI [11,2])
C0024485 (UMLS CUI [12])
C0079490 (UMLS CUI [13,1])
C0332197 (UMLS CUI [13,2])
C0243161 (UMLS CUI [1,2])
C2363751 (UMLS CUI [2,1])
C0020852 (UMLS CUI [2,2])
C2363751 (UMLS CUI [3,1])
C0020835 (UMLS CUI [3,2])
C2363751 (UMLS CUI [4,1])
C0020843 (UMLS CUI [4,2])
C2363751 (UMLS CUI [5,1])
C0020846 (UMLS CUI [5,2])
C0021036 (UMLS CUI [6,1])
C1524119 (UMLS CUI [6,2])
C0021037 (UMLS CUI [7,1])
C1524119 (UMLS CUI [7,2])
C0004965 (UMLS CUI [8])
C1704632 (UMLS CUI [9,1])
C1261322 (UMLS CUI [9,2])
C0085663 (UMLS CUI [10,1])
C0439165 (UMLS CUI [10,2])
C1533062 (UMLS CUI [11,1])
C0205234 (UMLS CUI [11,2])
C0024485 (UMLS CUI [12])
C0079490 (UMLS CUI [13,1])
C0332197 (UMLS CUI [13,2])
Prior Chemotherapy Quantity Multiple Myeloma | prior radiation therapy
Item
patients must have received no more than one cycle of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2])
Age
Item
patients must be < or = 75 years of age at the time of initial registration.
boolean
C0001779 (UMLS CUI [1])
Cardiac ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
ejection fraction by echo or muga >40% performed within 60 days prior to registration.
boolean
C0232174 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
Pulmonary function | FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test
Item
patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > or =50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, there must be a pulmonary consult documenting that the patient is a candidate for high dose therapy.
boolean
C0231921 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1287681 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
C0748133 (UMLS CUI [2])
C1287681 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
performance status | Bone pain
Item
patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
boolean
C1518965 (UMLS CUI [1])
C0151825 (UMLS CUI [2])
C0151825 (UMLS CUI [2])
Informed Consent
Item
all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Neoadjuvant Therapy
Item
induction exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,2])
Platelet Count measurement | Platelet Count measurement Related Multiple Myeloma
Item
platelet count < 30 x 10^9/l, unless myeloma-related
boolean
C0032181 (UMLS CUI [1])
C0032181 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C0032181 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Absolute neutrophil count | Absolute neutrophil count Related Multiple Myeloma
Item
anc < 1.0 x 10^9/l, unless myeloma-related
boolean
C0948762 (UMLS CUI [1])
C0948762 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C0948762 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Peripheral Neuropathy | CTCAE Grades
Item
grade > or =2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
C1516728 (UMLS CUI [2])
Hypersensitivity bortezomib | Hypersensitivity Boron | Hypersensitivity Mannitol
Item
hypersensitivity to bortezomib, boron, or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
Diabetic - poor control
Item
uncontrolled diabetes.
boolean
C0421258 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Cardiac Arrhythmia CONTROL DIFFICULT
Item
recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0742800 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0742800 (UMLS CUI [5,2])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0742800 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0742800 (UMLS CUI [5,2])
Chronic Obstructive Airway Disease | Restrictive pulmonary disease chronic
Item
evidence of chronic obstructive or chronic restrictive pulmonary disease.
boolean
C0024117 (UMLS CUI [1])
C0877013 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0877013 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix
Item
prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4])
Comorbidity Significant | Life-threatening infection Uncontrolled
Item
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0750502 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods
Item
pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])