ID

22125

Descrição

Velcade (Bortezomib), Adriamycin Dexamethasone (PAD) or Vincristine Adriamycin Dexamethasone in Second Line Treatment of Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00441168

Link

https://clinicaltrials.gov/show/NCT00441168

Palavras-chave

  1. 20/05/2017 20/05/2017 -
Transferido a

20 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00441168

Eligibility Multiple Myeloma NCT00441168

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed or refractory multiple myeloma following 1 previous line of therapy and, is scheduled by the investigator to be treated with vincristine, adriamycin and dexamethasone standard therapy
Descrição

refractory multiple myeloma, vincristine, adriamycin, dexamethasone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0042679
UMLS CUI [1,4]
C0085752
UMLS CUI [1,5]
C0011777
measurable secretory multiple myeloma based on defined criteria
Descrição

secretory multiple myeloma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1327616
karnofsky performance status of >or = 60%
Descrição

karnofsky performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
fulfils defined laboratory requirements within 14 days before baseline
Descrição

laboratory requirement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022877
if female, the patient is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control for defined period of time
Descrição

postmenopausal, contraception

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0700589
if male, the patient agrees to use an acceptable barrier method for contraception for a defined period of time.
Descrição

contraception

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than one previous line of therapy for multiple myeloma
Descrição

multiple myeloma previous therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1514463
use of bortezomib in the previous line of therapy and/or received bortezomib in a previous trial
Descrição

bortezomib

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1176309
known allergy or hypersensitivity to bortezomib, boron or mannitol
Descrição

hypersensitivity to bortezomib, boron, mannitol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C0006030
UMLS CUI [1,4]
C0024730
peripheral neuropathy or neuropathic pain of grade 2 or higher
Descrição

peripheral neuropathy, neuropathic pain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C0458960
myocardial infarction within 6 months of enrollment or had new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Descrição

heart diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799

Similar models

Eligibility Multiple Myeloma NCT00441168

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
refractory multiple myeloma, vincristine, adriamycin, dexamethasone
Item
relapsed or refractory multiple myeloma following 1 previous line of therapy and, is scheduled by the investigator to be treated with vincristine, adriamycin and dexamethasone standard therapy
boolean
C0026764 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0042679 (UMLS CUI [1,3])
C0085752 (UMLS CUI [1,4])
C0011777 (UMLS CUI [1,5])
secretory multiple myeloma
Item
measurable secretory multiple myeloma based on defined criteria
boolean
C0026764 (UMLS CUI [1,1])
C1327616 (UMLS CUI [1,2])
karnofsky performance status
Item
karnofsky performance status of >or = 60%
boolean
C0206065 (UMLS CUI [1])
laboratory requirement
Item
fulfils defined laboratory requirements within 14 days before baseline
boolean
C0022877 (UMLS CUI [1])
postmenopausal, contraception
Item
if female, the patient is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control for defined period of time
boolean
C0232970 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
contraception
Item
if male, the patient agrees to use an acceptable barrier method for contraception for a defined period of time.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
multiple myeloma previous therapy
Item
more than one previous line of therapy for multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
bortezomib
Item
use of bortezomib in the previous line of therapy and/or received bortezomib in a previous trial
boolean
C1176309 (UMLS CUI [1])
hypersensitivity to bortezomib, boron, mannitol
Item
known allergy or hypersensitivity to bortezomib, boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0006030 (UMLS CUI [1,3])
C0024730 (UMLS CUI [1,4])
peripheral neuropathy, neuropathic pain
Item
peripheral neuropathy or neuropathic pain of grade 2 or higher
boolean
C0031117 (UMLS CUI [1])
C0458960 (UMLS CUI [2])
heart diseases
Item
myocardial infarction within 6 months of enrollment or had new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
boolean
C0018799 (UMLS CUI [1])

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