ID

18138

Description

A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00057564

Link

https://clinicaltrials.gov/show/NCT00057564

Keywords

Versions (1)
  1. 10/22/16 10/22/16 -
Uploaded on

October 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00057564

English

Eligibility Multiple Myeloma NCT00057564

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
active multiple myeloma stage ii or iii durie salmon
Description

Multiple Myeloma | Staging

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0332305
measurable levels of myeloma paraprotein in serum (≥1.0g/dl) or urine (≥ 0.2g excreted in a 24-hour collection sample)
Description

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

Data type

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
eastern cooperative oncology group (ecog) performance status of 0, 1, 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
Description

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity | Hormonal contraception | Tubal Ligation | Contraception, Barrier | Latex condom | Vaginal contraceptive diaphragm

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0520483
UMLS CUI [5]
C0004764
UMLS CUI [6]
C3873750
UMLS CUI [7]
C0042241
males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity
Description

Gender Sex Behavior Contraception, Barrier | Gender Sex Behavior Latex condom

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036864
UMLS CUI [1,3]
C0004764
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036864
UMLS CUI [2,3]
C3873750
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
peripheral neuropathy ≥ to grade 2 of the nci ctc.
Description

Peripheral Neuropathy | CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
prior history of malignancy unless subject has been free of disease for ≥ 3 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
lab abnormality: absolute neutrophil count (anc) <1,000 cells/mm^3 (1.0 x 10^9/l)
Description

LABORATORY ABNORMALITIES | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0948762
lab abnormality: platelet count <50,000/mm^3 (50.0 x 10^9/l)
Description

LABORATORY ABNORMALITIES | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0032181
lab abnormality: serum creatinine >3.0 mg/dl (265 µmol/l)
Description

LABORATORY ABNORMALITIES | Creatinine measurement, serum

Data type

boolean

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

LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
lab abnormality: serum total bilirubin > 2.0 mg/dl (34 µmol/l)
Description

LABORATORY ABNORMALITIES | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1853129
UMLS CUI [2]
C1278039
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Similar models

Eligibility Multiple Myeloma NCT00057564

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Staging
Item
active multiple myeloma stage ii or iii durie salmon
boolean
C0026764 (UMLS CUI [1])
C0332305 (UMLS CUI [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 (≥1.0g/dl) or urine (≥ 0.2g excreted in a 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])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, 2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity | Hormonal contraception | Tubal Ligation | Contraception, Barrier | Latex condom | Vaginal contraceptive diaphragm
Item
women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2985296 (UMLS CUI [3])
C0520483 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C3873750 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
Gender Sex Behavior Contraception, Barrier | Gender Sex Behavior Latex condom
Item
males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity
boolean
C0079399 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0036864 (UMLS CUI [2,2])
C3873750 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy ≥ to grade 2 of the nci ctc.
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Malignant Neoplasms
Item
prior history of malignancy unless subject has been free of disease for ≥ 3 years
boolean
C0006826 (UMLS CUI [1])
LABORATORY ABNORMALITIES | Absolute neutrophil count
Item
lab abnormality: absolute neutrophil count (anc) <1,000 cells/mm^3 (1.0 x 10^9/l)
boolean
C1853129 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Platelet Count measurement
Item
lab abnormality: platelet count <50,000/mm^3 (50.0 x 10^9/l)
boolean
C1853129 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Creatinine measurement, serum
Item
lab abnormality: serum creatinine >3.0 mg/dl (265 µmol/l)
boolean
C1853129 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
LABORATORY ABNORMALITIES | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
lab abnormality: serum glutamic oxaloacetic transaminase (sgot) /aspartate aminotransferase (ast) or serum glutamic pyruvic transaminase (sgpt)/alanine transaminase (alt) >3.0 x upper limit of normal (uln)
boolean
C1853129 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
LABORATORY ABNORMALITIES | Serum total bilirubin measurement
Item
lab abnormality: serum total bilirubin > 2.0 mg/dl (34 µmol/l)
boolean
C1853129 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
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