Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of multiple myeloma
Item
Diagnosis of multiple myeloma
boolean
C0011900 (UMLS CUI 1)
C0026764 (UMLS CUI 1*1)
Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L, serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine M-protein of ≥200 mg/24 hr
Item
Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L, serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine M-protein of ≥200 mg/24 hr
boolean
C1513040 (UMLS CUI 2011AA)
C0036536 (UMLS CUI 2011AA)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C1532875 (UMLS CUI 2011AA)
414771005 (SNOMED CT 2011_0131)
C1532872 (UMLS CUI 2011AA)
414768002 (SNOMED CT 2011_0131)
C1532874 (UMLS CUI 2011AA)
414770006 (SNOMED CT 2011_0131)
C1532873 (UMLS CUI 2011AA)
414769005 (SNOMED CT 2011_0131)
C0700271 (UMLS CUI 2011AA)
C0456209 (UMLS CUI 2011AA)
276833005 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Previous treatment with VELCADE
Item
Previous treatment with VELCADE
boolean
C1514463 (UMLS CUI 2011AA)
C1176309 (UMLS CUI 2011AA)
407097007 (SNOMED CT 2011_0131)
More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6 month treatment-free interval)
Item
More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6 month treatment-free interval)
boolean
C0205172 (UMLS CUI 2011AA)
242762006 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL415196 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0556895 (UMLS CUI 2011AA)
229554006 (SNOMED CT 2011_0131)
CL423159 (UMLS CUI 2011AA)
13184001 (SNOMED CT 2011_0131)
C0242656 (UMLS CUI 2011AA)
246453008 (SNOMED CT 2011_0131)
10061818 (MedDRA 14.1)
CL414906 (UMLS CUI 2011AA)
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C0332296 (UMLS CUI 2011AA)
37837009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205172 (UMLS CUI 2011AA)
242762006 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2
Item
Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2
boolean
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
CL428997 (UMLS CUI 2011AA)
CL384738 (UMLS CUI 2011AA)
C1557258 (UMLS CUI 2011AA)
MTHU112833 (CTCAE 1105E)
C1557253 (UMLS CUI 2011AA)
MTHU112640 (CTCAE 1105E)
Any of the following within 3 weeks prior to randomization:
Item
Any of the following within 3 weeks prior to randomization:
boolean
CL407060 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis
Item
antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis
boolean
CL378288 (UMLS CUI 2011AA)
C0949266 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
C0032134 (UMLS CUI 2011AA)
20720000 (SNOMED CT 2011_0131)
10035486 (MedDRA 14.1)
99.71 (ICD-9-CM Version 2011)
Any of the following within 2 weeks prior to randomization:
Item
Any of the following within 2 weeks prior to randomization:
boolean
CL407060 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
radiation therapy, major surgery (kyphoplasty is not considered major surgery)
Item
radiation therapy, major surgery (kyphoplasty is not considered major surgery)
boolean
C0034619 (UMLS CUI 2011AA)
C0679637 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C1455863 (UMLS CUI 2011AA)
10064702 (MedDRA 14.1)
81.66 (ICD-9-CM Version 2011)
Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
Item
Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C0026764 (UMLS CUI 2011AA)
109989006 (SNOMED CT 2011_0131)
10028228 (MedDRA 14.1)
C90.0 (ICD-10-CM Version 2010)
203.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
CL415147 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0007099 (UMLS CUI 2011AA)
109355002 (SNOMED CT 2011_0131)
10061450 (MedDRA 14.1)
D09.9 (ICD-10-CM Version 2010)
234.9 (ICD-9-CM Version 2011)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)

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