ID

18208

Beschrijving

A Study of Lenalidomide Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00424047

Link

https://clinicaltrials.gov/show/NCT00424047

Trefwoorden

Versies (1)
  1. 25-10-16 25-10-16 -
Geüploaded op

25 oktober 2016

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00424047

Engels

Eligibility Multiple Myeloma NCT00424047

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Multiple Myeloma | Staging

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0332305
measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
Beschrijving

Serum paraprotein measurement Multiple Myeloma | Urine paraprotein measurement Multiple Myeloma | Specimen Collection 24 Hours

Datatype

boolean

Alias
UMLS CUI [1,1]
C0585639
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C0585640
UMLS CUI [2,2]
C0026764
UMLS CUI [3,1]
C0200345
UMLS CUI [3,2]
C1442770
eastern cooperative oncology group (ecog) performance status score of 0,1, or 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
Beschrijving

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Dexamethasone High dose | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C0242656
pregnant or lactating females
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the development of a desquamating rash while taking thalidomide
Beschrijving

Thalidomide | Rash desquamating

Datatype

boolean

Alias
UMLS CUI [1]
C0039736
UMLS CUI [2]
C0542171
use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
Beschrijving

Therapeutic procedure Against Multiple Myeloma | Investigational Therapies Against Multiple Myeloma | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0026764
UMLS CUI [3]
C0949266
laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm^3
Beschrijving

LABORATORY ABNORMALITIES | Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0948762
laboratory abnormalities: platelet count < 75,000/mm^3
Beschrijving

LABORATORY ABNORMALITIES | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0032181
laboratory abnormalities: serum creatinine > 2.5 mg/dl
Beschrijving

LABORATORY ABNORMALITIES | Creatinine measurement, serum

Datatype

boolean

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

LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

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

LABORATORY ABNORMALITIES | Serum total bilirubin measurement

Datatype

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 ≥ 3 years.
Beschrijving

Malignant Neoplasms | Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0026764
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Similar models

Eligibility Multiple Myeloma NCT00424047

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Serum paraprotein measurement Multiple Myeloma | Urine paraprotein measurement Multiple Myeloma | Specimen Collection 24 Hours
Item
measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
boolean
C0585639 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0585640 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0200345 (UMLS CUI [3,1])
C1442770 (UMLS CUI [3,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score of 0,1, or 2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
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])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Thalidomide | Rash desquamating
Item
the development of a desquamating rash while taking thalidomide
boolean
C0039736 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
Therapeutic procedure Against Multiple Myeloma | Investigational Therapies Against Multiple Myeloma | Therapies, Investigational
Item
use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C0949266 (UMLS CUI [3])
LABORATORY ABNORMALITIES | Absolute neutrophil count
Item
laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm^3
boolean
C1853129 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Platelet Count measurement
Item
laboratory abnormalities: platelet count < 75,000/mm^3
boolean
C1853129 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Creatinine measurement, serum
Item
laboratory abnormalities: serum creatinine > 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 aminotransferase (ast) or serum glutamic pyruvic transaminase (sgpt)/alanine aminotransferase (alt) > 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 > 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 ≥ 3 years.
boolean
C0006826 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
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