Age
Item
male or female patients from 18 to 80
boolean
C0001779 (UMLS CUI [1])
Extramedullary Plasmacytoma | Plasma cell myeloma recurrent | Myeloma Refractory | Exposure to Proteasome inhibitor | Proteasome inhibitor Absent | Absence Unresponsive to Treatment Proteasome inhibitor
Item
biopsy-proven emp with relapsed or refractory myeloma disease. patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
boolean
C0278619 (UMLS CUI [1])
C1370446 (UMLS CUI [2])
C0026764 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C1443643 (UMLS CUI [4,2])
C1443643 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0332197 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
C1443643 (UMLS CUI [6,3])
Disease Treatment required for Additional
Item
disease requiring further treatment
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
Measurable Disease | M Protein Measurable | Extramedullary Plasmacytoma Measurable
Item
measurable disease such as m protein and objective and measurable of emp
boolean
C1513041 (UMLS CUI [1])
C0700271 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C0278619 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Criteria Fulfill
Item
meet the clinical laboratories criteria as specified in the protocol
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent
Item
voluntary written consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female patients who are lactating, breastfeeding or pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Diseases Uncontrolled
Item
evidence of current uncontrolled cardiovascular conditions as specified in study protocol
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Chemotherapy Other Extramedullary Plasmacytoma | Immunotherapy Other Extramedullary Plasmacytoma | Therapeutic radiology procedure Other Extramedullary Plasmacytoma
Item
requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of emp.
boolean
C0392920 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0278619 (UMLS CUI [1,3])
C0021083 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0278619 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0278619 (UMLS CUI [3,3])
Comorbidity Systemic Study Subject Participation Status Inappropriate | Comorbidity Severe Study Subject Participation Status Inappropriate | Comorbidity Systemic Interferes with Evaluation | Comorbidity Severe Interferes with Evaluation
Item
comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
C0009488 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C1261322 (UMLS CUI [3,4])
C0009488 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C1261322 (UMLS CUI [4,4])
Communicable Disease | HIV Seropositivity | Hepatitis B | Hepatitis C
Item
ongoing or active infection, known hiv positive, active hepatitis b or c infection
boolean
C0009450 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drugs
Item
known allergy to any of the study medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])