ID

4970

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00722566

Link

http://clinicaltrials.gov/show/NCT00722566

Palavras-chave

Versões (2)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 15/04/2014 15/04/2014 - Julian Varghese
Transferido a

15 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT00722566 Multiple Myeloma

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrição

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Descrição

age at least 18 Years

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of multiple myeloma
Descrição

Diagnosis of multiple myeloma

Tipo de dados

boolean

Alias
UMLS CUI 1
C0011900
UMLS CUI 1*1
C0026764
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
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0036536
UMLS CUI 2011AA
C0026764
SNOMED CT 2011_0131
109989006
MedDRA 14.1
10028228
ICD-10-CM Version 2010
C90.0
ICD-9-CM Version 2011
203.0
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C1532875
SNOMED CT 2011_0131
414771005
UMLS CUI 2011AA
C1532872
SNOMED CT 2011_0131
414768002
UMLS CUI 2011AA
C1532874
SNOMED CT 2011_0131
414770006
UMLS CUI 2011AA
C1532873
SNOMED CT 2011_0131
414769005
UMLS CUI 2011AA
C0700271
UMLS CUI 2011AA
C0456209
SNOMED CT 2011_0131
276833005
Ausschlusskriterien
Descrição

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Previous treatment with VELCADE
Descrição

Previous treatment with VELCADE

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1176309
SNOMED CT 2011_0131
407097007
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)
Descrição

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)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0205172
SNOMED CT 2011_0131
242762006
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
CL415196
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0556895
SNOMED CT 2011_0131
229554006
UMLS CUI 2011AA
CL423159
SNOMED CT 2011_0131
13184001
UMLS CUI 2011AA
C0242656
SNOMED CT 2011_0131
246453008
MedDRA 14.1
10061818
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C0332296
SNOMED CT 2011_0131
37837009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205172
SNOMED CT 2011_0131
242762006
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2
Descrição

Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
UMLS CUI 2011AA
CL428997
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C1557258
CTCAE 1105E
MTHU112833
UMLS CUI 2011AA
C1557253
CTCAE 1105E
MTHU112640
Any of the following within 3 weeks prior to randomization:
Descrição

Any of the following within 3 weeks prior to randomization:

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis
Descrição

antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL378288
UMLS CUI 2011AA
C0949266
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C0032134
SNOMED CT 2011_0131
20720000
MedDRA 14.1
10035486
ICD-9-CM Version 2011
99.71
Any of the following within 2 weeks prior to randomization:
Descrição

Any of the following within 2 weeks prior to randomization:

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
radiation therapy, major surgery (kyphoplasty is not considered major surgery)
Descrição

radiation therapy, major surgery (kyphoplasty is not considered major surgery)

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0679637
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1455863
MedDRA 14.1
10064702
ICD-9-CM Version 2011
81.66
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
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0026764
SNOMED CT 2011_0131
109989006
MedDRA 14.1
10028228
ICD-10-CM Version 2010
C90.0
ICD-9-CM Version 2011
203.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0007099
SNOMED CT 2011_0131
109355002
MedDRA 14.1
10061450
ICD-10-CM Version 2010
D09.9
ICD-9-CM Version 2011
234.9
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
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
Ausschlusskriterien
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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