ECOG
Item
eastern cooperative oncology group (ecog) performance status score 0-2
boolean
C1520224 (UMLS CUI [1])
Diagnosis
Item
measurable or secretory multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C1327616 (UMLS CUI [2,2])
Course of the disease
Item
relapse or progression of myeloma following prior systemic antineoplastic therapy
boolean
C0277556 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C2346834 (UMLS CUI [1,3])
C0205373 (UMLS CUI [1,4])
C0178874 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C2346834 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
Lab values
Item
pretreatment clinical laboratory values meeting protocol-specified criteria
boolean
C3539076 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Kardiac function
Item
left ventricular ejection fraction rate within normal limits
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
PNS
Item
peripheral neuropathy or neuralgia >=2, according to national cancer institute common terminology criteria for adverse events (nci-ctcae) version 4.0
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0027796 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Related diseases
Item
diagnosis of primary amyloidosis, plasma cell leukemia, or other similar conditions
boolean
C0268381 (UMLS CUI [1])
C0268381 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
Makroglobulinemia
Item
diagnosis of waldenstrom macroglobulinemia with protocol-specified immunoglobulin levels
boolean
C0024419 (UMLS CUI [1,1])
C0202084 (UMLS CUI [1,2])
Histone-deacetylase inhibitor therapy
Item
prior histone-deacetylase inhibitor therapy - more than 3 prior lines of therapy
boolean
C1514463 (UMLS CUI [1,1])
C1512474 (UMLS CUI [1,2])
Cardiac risk factors
Item
cardiac risk factors: unstable angina or myocardial infarction within the preceding 12 months, congestive heart failure (new york heart association class ii-iv), known presence of dilated, hypertrophic, or restrictive cardiomyopathy
boolean
C2024776 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0007194 (UMLS CUI [5,1])
C0007196 (UMLS CUI [5,2])
C0007193 (UMLS CUI [5,3])
Cardiac risk
Item
any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the patient at an unacceptably increased risk with study drug
boolean
C0018787 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
ECG abnormalities
Item
history of any of the following: sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, atrial fibrillation, cardiac arrest, mobitz ii second degree heart block, or third degree heart block - qtc at screening > 450 ms in males / > 470 ms in females
boolean
C0522055 (UMLS CUI [1])
C0750197 (UMLS CUI [2])
C0042510 (UMLS CUI [3])
C0040479 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0018790 (UMLS CUI [6])
C0155700 (UMLS CUI [7])
C0151517 (UMLS CUI [8])
C1560305 (UMLS CUI [9,1])
C0220908 (UMLS CUI [9,2])
Family history
Item
family history of short qt syndrome, long qt syndrome
boolean
C0241889 (UMLS CUI [1,1])
C0023976 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C2348199 (UMLS CUI [2,2])
Cardiac comorbidities
Item
obligate use of a cardiac pacemaker - use of medications that may cause torsades de pointes
boolean
C0030163 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0040479 (UMLS CUI [2,2])
C0458082 (UMLS CUI [2,3])