ID

30871

Beschrijving

Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT; ODM derived from: https://clinicaltrials.gov/show/NCT00861250

Link

https://clinicaltrials.gov/show/NCT00861250

Trefwoorden

Versies (1)
  1. 29-06-18 29-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00861250

Engels

Eligibility Multiple Myeloma NCT00861250

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic multiple myeloma
Beschrijving

Multiple Myeloma Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
age 18-65 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
who performance status ≥ 2, unless related to mm
Beschrijving

WHO performance status scale | Exception Relationship Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0026764
severe cardiac dysfunction
Beschrijving

Cardiac dysfunction Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0205082
history of hypotension
Beschrijving

Hypotension

Datatype

boolean

Alias
UMLS CUI [1]
C0020649
serious medical or psychiatric illness
Beschrijving

Illness Serious | Serious mental illness

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3841614
severe hepatic dysfunction
Beschrijving

Liver Dysfunction Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
severe polyneuropathy ≥ grade 2
Beschrijving

Polyneuropathy Severe CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0152025
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1516728
active, uncontrolled infection
Beschrijving

Communicable Disease Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
previously treated with chemotherapy or extensive radiotherapy for mm
Beschrijving

Chemotherapy Multiple Myeloma | Therapeutic radiology procedure Extensive Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205231
UMLS CUI [2,3]
C0026764
known hiv positivity
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
severe renal dysfunction with need of dialyses
Beschrijving

Renal dysfunction Severe | Patient need for Dialysis

Datatype

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0011946
history of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer
Beschrijving

Malignant Neoplasms Disease length | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
female patients who are pregnant or nursing
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male or female patients of reproductive potential who are not practising effective means of contraception
Beschrijving

Females & males of reproductive potential Contraceptive methods Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
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Similar models

Eligibility Multiple Myeloma NCT00861250

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic
Item
symptomatic multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Age
Item
age 18-65 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
WHO performance status scale | Exception Relationship Multiple Myeloma
Item
who performance status ≥ 2, unless related to mm
boolean
C1298650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Cardiac dysfunction Severe
Item
severe cardiac dysfunction
boolean
C3277906 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hypotension
Item
history of hypotension
boolean
C0020649 (UMLS CUI [1])
Illness Serious | Serious mental illness
Item
serious medical or psychiatric illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3841614 (UMLS CUI [2])
Liver Dysfunction Severe
Item
severe hepatic dysfunction
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Polyneuropathy Severe CTCAE Grades
Item
severe polyneuropathy ≥ grade 2
boolean
C0152025 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Communicable Disease Uncontrolled
Item
active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Chemotherapy Multiple Myeloma | Therapeutic radiology procedure Extensive Multiple Myeloma
Item
previously treated with chemotherapy or extensive radiotherapy for mm
boolean
C0392920 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
HIV Seropositivity
Item
known hiv positivity
boolean
C0019699 (UMLS CUI [1])
Renal dysfunction Severe | Patient need for Dialysis
Item
severe renal dysfunction with need of dialyses
boolean
C3279454 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
Malignant Neoplasms Disease length | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
history of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer
boolean
C0006826 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
female patients who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Lacking
Item
male or female patients of reproductive potential who are not practising effective means of contraception
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
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