ID

18137

Beschreibung

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00056160

Link

https://clinicaltrials.gov/show/NCT00056160

Stichworte

Versionen (1)
  1. 22.10.16 22.10.16 -
Hochgeladen am

22. Oktober 2016

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00056160

Englisch

Eligibility Multiple Myeloma NCT00056160

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
prior or current diagnosis durie-salmon stage ii or iii multiple myeloma.
Beschreibung

Multiple Myeloma | Staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0332305
no more than 3 previous anti-myeloma regimens
Beschreibung

Regimen Quantity Against Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0521124
UMLS CUI [1,4]
C0026764
no high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
Beschreibung

Dexamethasone High dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0444956
measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
Beschreibung

Multiple Myeloma Serum paraprotein level result | Multiple Myeloma Urine paraprotein level result | Specimen Collection 24 Hours

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1318383
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C1318384
UMLS CUI [3,1]
C0200345
UMLS CUI [3,2]
C1442770
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior development of disease progression during high-dose dexamethasone containing therapy.
Beschreibung

Dexamethasone High dose | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C0242656
laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm cubed
Beschreibung

LABORATORY ABNORMALITIES | Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0948762
laboratory abnormalities: platelet count less than 75,000/mm cubed
Beschreibung

LABORATORY ABNORMALITIES | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0032181
laboratory abnormalities: serum creatinine greater than 2.5 mg/dl
Beschreibung

LABORATORY ABNORMALITIES | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0201976
laboratory abnormalities: serum glutamic oxaloacetic transaminase (sgot, aspartate transaminase [ast]) or serum glutamic pyruvic transaminase (sgpt, alanine transaminase [alt])greater than 3.0 x upper limit of normal
Beschreibung

LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
laboratory abnormalities: serum total bilirubin greater than 2.0 mg/dl
Beschreibung

LABORATORY ABNORMALITIES | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C1278039
prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
Beschreibung

Malignant Neoplasms | Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0026764
known hypersensitivity to thalidomide or dexamethasone.
Beschreibung

Hypersensitivity Thalidomide | Dexamethasone allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2]
C0571611
development of a desquamating rash while taking thalidomide.
Beschreibung

Thalidomide | Rash desquamating

Datentyp

boolean

Alias
UMLS CUI [1]
C0039736
UMLS CUI [2]
C0542171
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00056160

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Staging
Item
prior or current diagnosis durie-salmon stage ii or iii multiple myeloma.
boolean
C0026764 (UMLS CUI [1])
C0332305 (UMLS CUI [2])
Regimen Quantity Against Multiple Myeloma
Item
no more than 3 previous anti-myeloma regimens
boolean
C0040808 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C0026764 (UMLS CUI [1,4])
Dexamethasone High dose
Item
no high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
boolean
C0011777 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
Multiple Myeloma Serum paraprotein level result | Multiple Myeloma Urine paraprotein level result | Specimen Collection 24 Hours
Item
measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
boolean
C0026764 (UMLS CUI [1,1])
C1318383 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C1318384 (UMLS CUI [2,2])
C0200345 (UMLS CUI [3,1])
C1442770 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Dexamethasone High dose | Disease Progression
Item
prior development of disease progression during high-dose dexamethasone containing therapy.
boolean
C0011777 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Absolute neutrophil count
Item
laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm cubed
boolean
C1853129 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Platelet Count measurement
Item
laboratory abnormalities: platelet count less than 75,000/mm cubed
boolean
C1853129 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Creatinine measurement, serum
Item
laboratory abnormalities: serum creatinine greater than 2.5 mg/dl
boolean
C1853129 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
laboratory abnormalities: serum glutamic oxaloacetic transaminase (sgot, aspartate transaminase [ast]) or serum glutamic pyruvic transaminase (sgpt, alanine transaminase [alt])greater than 3.0 x upper limit of normal
boolean
C1853129 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
LABORATORY ABNORMALITIES | Serum total bilirubin measurement
Item
laboratory abnormalities: serum total bilirubin greater than 2.0 mg/dl
boolean
C1853129 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Malignant Neoplasms | Multiple Myeloma
Item
prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
boolean
C0006826 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
Hypersensitivity Thalidomide | Dexamethasone allergy
Item
known hypersensitivity to thalidomide or dexamethasone.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0571611 (UMLS CUI [2])
Thalidomide | Rash desquamating
Item
development of a desquamating rash while taking thalidomide.
boolean
C0039736 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
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