Multiple Myeloma Symptomatic
Item
symptomatic multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Age
Item
male or female subject age >= 70 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Quantity
Item
the subject has received at least one previous line of therapy including:
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
First line treatment | VBMCP protocol | VBAD protocol | VAD regimen | Second line treatment | bortezomib | Thalidomide | lenalidomide
Item
front-line treatment with vbmcp/vbad or vad or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide
boolean
C1708063 (UMLS CUI [1])
C0950525 (UMLS CUI [2])
C0379779 (UMLS CUI [3])
C0077975 (UMLS CUI [4])
C1710038 (UMLS CUI [5])
C1176309 (UMLS CUI [6])
C0039736 (UMLS CUI [7])
C1144149 (UMLS CUI [8])
Informed Consent
Item
the subject has given voluntary written informed consent
boolean
C0021430 (UMLS CUI [1])
First line treatment | bortezomib | Thalidomide | lenalidomide
Item
use of bortezomib, thalidomide or lenalidomide as front-line therapy
boolean
C1708063 (UMLS CUI [1])
C1176309 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C1144149 (UMLS CUI [4])
ECOG performance status
Item
ecog satus >=2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction <40%
boolean
C0428772 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test | Forced vital capacity
Item
dlco and fvc <39% theoretical value
boolean
C1516251 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
Liver Dysfunction | Serum total bilirubin measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
abnormal liver function(total bilirubin > 2 mg/dl and/or alt or ast > 3 x uln)
boolean
C0086565 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Serum creatinine measurement Transplantation | Creatinine clearance measurement
Item
serum creatinine at transplant >1.6 mg/dl and/or creatinine clearance < 65 ml/minute
boolean
C0201976 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Sepsis Treatment required for
Item
subject has an active systemic infection requiring treatment
boolean
C0243026 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe
Item
subject had a myocardial infarction within 6 months of enrollment or has nyha class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0421196 (UMLS CUI [3])
C0085612 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Medical condition Serious Interferes with Treatment completion | Hepatic impairment Severe | Disorder of pericardium | Acute diffuse infiltrative lung disease | Mental disorder Interferes with Treatment completion
Item
subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0265122 (UMLS CUI [3])
C1735346 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0580352 (UMLS CUI [5,3])
HIV Seropositivity
Item
subject is known to be immunodeficiency virus (hiv)-positive
boolean
C0019699 (UMLS CUI [1])
Investigational New Drugs | Investigational Medical Device
Item
subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Pregnancy | Breast Feeding | Gender Pregnancy test negative | Postmenopausal state | Female Sterilization
Item
if female, the subject is pregnant or breast-feeding. confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. pregnancy testing is not required for postmenopausal or surgically sterilized women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0015787 (UMLS CUI [5])