Multiple Myeloma | Therapeutic procedure Quantity failed | Recurrent disease | Refractory Disease
Item
confirmed diagnosis of multiple myeloma with relapsed or refractory disease after failing at least 2 prior lines of therapy
boolean
C0026764 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3])
C1514815 (UMLS CUI [4])
bortezomib | Combined Modality Therapy
Item
prior treatment regimen must have included bortezomib (alone or in combination with other agents)
boolean
C1176309 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
Measurable Disease secretion | Serum paraprotein measurement monoclonal
Item
measurable secretory disease defined as either serum monoclonal paraprotein (m-
boolean
C1513041 (UMLS CUI [1,1])
C1327616 (UMLS CUI [1,2])
C0585639 (UMLS CUI [2,1])
C0746619 (UMLS CUI [2,2])
M Protein | Monoclonal Protein Measurement In Urine
Item
protein) greater than or equal to (>=) 1 gram per deciliter (g/dl) or urine monoclonal (light chain) protein (greater than (>) 200 milligram/24 hours)
boolean
C0700271 (UMLS CUI [1])
C2984963 (UMLS CUI [2,1])
C0042037 (UMLS CUI [2,2])
ECOG performance status | Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
eastern cooperative oncology group (ecog) performance status score of less than or equal to (<=) 2 - participants of childbearing potential must use adequate birth control measures, female participants of childbearing potential must have a negative serum pregnancy test at screening
boolean
C1520224 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
Cancer treatment Systemic | Clarithromycin | Therapeutic radiology procedure | Nitrosoureas | Alkylating Agents | Antineoplastic Agents | Chemotherapy
Item
treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days before the first dose of study agent - treatment with nitrosoureas (a group of alkylating agents used as antineoplastic drugs in the chemotherapy) within 42 days before the first dose of study agent
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0055856 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
C0002073 (UMLS CUI [5])
C0003392 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
Major surgery | Operative Surgical Procedures Planned | Minor Surgical Procedures
Item
major surgery within 30 days before the first dose of study agent or planning to have surgery (except for minor surgical procedures) during the study
boolean
C0679637 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0038904 (UMLS CUI [3])
Comorbidity Serious | Mental disorders Serious | Communicable Diseases Uncontrolled | Heart Diseases | Ischaemic coronary artery disorders | Congestive heart failure Uncontrolled | Medical condition Uncontrolled | Diabetic - poor control | LABORATORY ABNORMALITIES At risk Study Subject Participation Status | LABORATORY ABNORMALITIES Interfere with Research results
Item
serious concurrent illness (medical or psychiatric), uncontrolled infection, or significant cardiac disease characterized by significant ischemic coronary disease (an imbalance between myocardial functional requirements and the capacity of the coronary vessels to supply sufficient blood flow) or congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body) not under medical control, or any uncontrolled medical condition (for example: uncontrolled diabetes), including the presence of clinical laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4])
C0852149 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C3843040 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0421258 (UMLS CUI [8])
C1853129 (UMLS CUI [9,1])
C1444641 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C1853129 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0683954 (UMLS CUI [10,3])
HIV Seropositivity Serum blood test Positive | Hepatitis A | Hepatitis B | Hepatitis C
Item
known to be seropositive (giving a positive result in a test of blood serum) for human immunodeficiency virus (hiv), or active hepatitis a, b or c infection
boolean
C0019699 (UMLS CUI [1,1])
C0558979 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])