ID

30885

Description

Quality of Life of Non-transplant Candidate Multiple Myeloma Patients Treated With Early Bortezomib; ODM derived from: https://clinicaltrials.gov/show/NCT01060202

Link

https://clinicaltrials.gov/show/NCT01060202

Keywords

Versions (1)
  1. 7/2/18 7/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01060202

English

Eligibility Multiple Myeloma NCT01060202

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic multiple myeloma patient
Description

Multiple Myeloma Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
ecog score less than 3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patient is not a candidate for stem cell transplantation
Description

Patients Inappropriate Stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1504389
previous treatment duration is less than 6 months
Description

Prior Therapy Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0449238
previous treatment response is less than partial response (pr)
Description

Prior Therapy Partial response failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1521726
UMLS CUI [1,3]
C0231175
willing and able to complete the questionnaire
Description

Questionnaire Completion Willing | Questionnaire Completion Able

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0085732
patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Description

Informed Consent | Informed Consent Patient Representatives

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to bortezomib
Description

Hypersensitivity Bortezomib

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
acute severe infection requiring antibiotics therapy
Description

Communicable Disease Severe Requirement Antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0338237
pre-existing peripheral neuropathy greater than or equal to grade 2
Description

Peripheral Neuropathy Pre-existing CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
uncontrolled or severe cardiovascular disease
Description

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
pregnancy or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Myeloma NCT01060202

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic
Item
symptomatic multiple myeloma patient
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
ECOG performance status
Item
ecog score less than 3
boolean
C1520224 (UMLS CUI [1])
Patients Inappropriate Stem cell transplant
Item
patient is not a candidate for stem cell transplantation
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1504389 (UMLS CUI [1,3])
Prior Therapy Duration
Item
previous treatment duration is less than 6 months
boolean
C1514463 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Prior Therapy Partial response failed
Item
previous treatment response is less than partial response (pr)
boolean
C1514463 (UMLS CUI [1,1])
C1521726 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Questionnaire Completion Willing | Questionnaire Completion Able
Item
willing and able to complete the questionnaire
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representatives
Item
patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Bortezomib
Item
known hypersensitivity to bortezomib
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
Communicable Disease Severe Requirement Antibiotic therapy
Item
acute severe infection requiring antibiotics therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0338237 (UMLS CUI [1,4])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
pre-existing peripheral neuropathy greater than or equal to grade 2
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe
Item
uncontrolled or severe cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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