ID

22125

Description

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

Keywords

  1. 5/20/17 5/20/17 -
Uploaded on

May 20, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Multiple Myeloma NCT00441168

Eligibility Multiple Myeloma NCT00441168

Inclusion Criteria
Description

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
Description

refractory multiple myeloma, vincristine, adriamycin, dexamethasone

Data type

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
Description

secretory multiple myeloma

Data type

boolean

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

karnofsky performance status

Data type

boolean

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

laboratory requirement

Data type

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
Description

postmenopausal, contraception

Data type

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.
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

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

multiple myeloma previous therapy

Data type

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
Description

bortezomib

Data type

boolean

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

hypersensitivity to bortezomib, boron, mannitol

Data type

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
Description

peripheral neuropathy, neuropathic pain

Data type

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.
Description

heart diseases

Data type

boolean

Alias
UMLS CUI [1]
C0018799

Similar models

Eligibility Multiple Myeloma NCT00441168

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial