Multiple Myeloma | Therapeutic procedure High dose Absent | Hemopoietic stem cell transplant Absent | Age | Comorbidity
Item
newly diagnosed patients with overt multiple myeloma who are not candidates for hdt/sct because of old age (> 65) or presence of comorbid conditions likely to have a negative impact on tolerability of hdt/sct. sponsors review this conditions and approval is required.
boolean
C0026764 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0472699 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
Measurable Disease | M Protein Serum | M Protein Urine
Item
presence of measurable disease : serum m-protein > 1g/dl or urine m- protein > 400mg/day
boolean
C1513041 (UMLS CUI [1])
C0700271 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
C0700271 (UMLS CUI [3,1])
C0042036 (UMLS CUI [3,2])
ECOG performance status
Item
performance status £ ecog 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
expected survival ³ 6 months
boolean
C0023671 (UMLS CUI [1])
Laboratory Results Pretreatment | Platelet Count measurement | Hemoglobin measurement | Red Blood Cell Transfusion | Recombinant Erythropoietin | Absolute neutrophil count | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
pretreatment clinical laboratory values meeting the following criteria within 14 days before enrollment platelet ≥ 100 x 109/l hemoglobin ≥ 8 g/dl (≥ 4.96 mol/l) prior rbc transfusion or recombinant human erythropoietin use is allowed) absolute neutrophil count (anc) ≥ 1.0 x 109/l aspartate aminotransferase (ast) ≤ 2.5 times the upper limit of normal alanine aminotransferase (alt) ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤
boolean
C1254595 (UMLS CUI [1,1])
C3539075 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0086252 (UMLS CUI [4])
C0376541 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201976 (UMLS CUI [10])
Corrected serum calcium measurement
Item
3mg/dl corrected serum calcium <14 mg/dl (<3.5 mmol/l)
boolean
C0455288 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representatives
Item
subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Smoldering myeloma | Indolent Myeloma
Item
smoldering or indolent myeloma
boolean
C1531608 (UMLS CUI [1])
C1334169 (UMLS CUI [2])
Allergic Reaction Boron Compounds | Allergic Reaction Mannitol Compound
Item
history of allergic reaction attributable to compounds containing boron or mannitol
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
Hypersensitivity Thalidomide | Dexamethasone allergy
Item
known hypersensitivity to thalidomide or dexamethasone
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0571611 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades
Item
peripheral neuropathy or neuropathic pain grade 2 or higher as defined by nci ctcae version 3
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0458960 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis | Cardiac ejection fraction | Conduction disorder of the heart Severe | Hypotension | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
uncontrolled or severe cardiovascular disease, including mi within 6 months of enrolment, new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : severe conduction disorder : hypotension (sitting systolic bp ≤ 100 mmhg and/or sitting diastolic bp ≤ 60 mmhg
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0421196 (UMLS CUI [5])
C0265122 (UMLS CUI [6])
C0268407 (UMLS CUI [7])
C0232174 (UMLS CUI [8])
C0264886 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0020649 (UMLS CUI [10])
C1319893 (UMLS CUI [11])
C1319894 (UMLS CUI [12])
Sepsis
Item
sepsis
boolean
C0243026 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetic - poor control
Item
uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Recurrent deep vein thrombosis | Pulmonary Embolism
Item
recurrent dvt or pulmonary embolism
boolean
C1735901 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Ulcer Endoscopy of stomach
Item
active ulcers detected by gastroscopy
boolean
C0041582 (UMLS CUI [1,1])
C0017195 (UMLS CUI [1,2])
Illness Serious Interferes with Study Subject Participation Status | Mental disorder Serious Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Extensive Radiation
Item
receipt of extensive radiation therapy within 4 weeks
boolean
C1517030 (UMLS CUI [1])