ID

30850

Beschrijving

Preemptive Strike With Bortezomib in Multiple Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00657553

Link

https://clinicaltrials.gov/show/NCT00657553

Trefwoorden

Versies (1)
  1. 27-06-18 27-06-18 -
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See clinicaltrials.gov

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27 juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00657553

Engels

Eligibility Multiple Myeloma NCT00657553

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with multiple myeloma currently or previously enrolled on uark 98-026 and currently event-free at the time of the evaluation.
Beschrijving

Multiple Myeloma | Study Subject Participation Status | Event Free of

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C2348568
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C0332296
performance status of 0-2 based of swog criteria
Beschrijving

Performance status SWOG Criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C1519429
UMLS CUI [1,3]
C0243161
previously documented platelet count > 75,000/ul within a 35 days prior to enrollment
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
previously documented peripheral absolute neutrophil count >1,000/ul within 35 days prior to enrollment.
Beschrijving

Absolute neutrophil count Peripheral blood

Datatype

boolean

Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C0229664
adequate renal function
Beschrijving

Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
female subject is post-menopausal or willing to use acceptable birth control
Beschrijving

Postmenopausal state | Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
male subjects agree to use acceptable method of contraceptive
Beschrijving

Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to bortezomib, boron, or mannitol
Beschrijving

Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3]
C0571922
female subject is pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
experienced myocardial infraction within 6 months prior to enrollment
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
received other investigational new drugs within 14 days before enrollment
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
received any anti-myeloma therapy within 14 days
Beschrijving

Therapeutic procedure Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026764
serious medical or psychiatric illness likely to interfere with participation in this clinical study
Beschrijving

Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
diagnosed or treated for another malignancy within 3 years of enrollment
Beschrijving

Cancer Other Diagnosed | Cancer Other Treated

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C1522326
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Similar models

Eligibility Multiple Myeloma NCT00657553

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Study Subject Participation Status | Event Free of
Item
diagnosed with multiple myeloma currently or previously enrolled on uark 98-026 and currently event-free at the time of the evaluation.
boolean
C0026764 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
Performance status SWOG Criteria
Item
performance status of 0-2 based of swog criteria
boolean
C1518965 (UMLS CUI [1,1])
C1519429 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Platelet Count measurement
Item
previously documented platelet count > 75,000/ul within a 35 days prior to enrollment
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count Peripheral blood
Item
previously documented peripheral absolute neutrophil count >1,000/ul within 35 days prior to enrollment.
boolean
C0948762 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Gender Contraceptive methods
Item
female subject is post-menopausal or willing to use acceptable birth control
boolean
C0232970 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Gender Contraceptive methods
Item
male subjects agree to use acceptable method of contraceptive
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
hypersensitivity to bortezomib, boron, or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
female subject is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Myocardial Infarction
Item
experienced myocardial infraction within 6 months prior to enrollment
boolean
C0027051 (UMLS CUI [1])
Investigational New Drugs
Item
received other investigational new drugs within 14 days before enrollment
boolean
C0013230 (UMLS CUI [1])
Therapeutic procedure Multiple Myeloma
Item
received any anti-myeloma therapy within 14 days
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Cancer Other Diagnosed | Cancer Other Treated
Item
diagnosed or treated for another malignancy within 3 years of enrollment
boolean
C1707251 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
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