ID

13210

Beschrijving

Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally; ODM derived from: https://clinicaltrials.gov/show/NCT00083538

Link

https://clinicaltrials.gov/show/NCT00083538

Trefwoorden

  1. 24-01-16 24-01-16 -
Geüploaded op

24 januari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00083538

Eligibility Multiple Myeloma NCT00083538

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have confirmed diagnosis of one of the following: smoldering or indolent multiple myeloma, multiple myeloma more than 1 year after autologous transplant and with stable disease, or multiple myeloma with cytogenetic abnormalities
Beschrijving

multiple myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
patients with secretory iga or igg must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available
Beschrijving

secretion

Datatype

boolean

Alias
UMLS CUI [1]
C0036536
karnofsky performance score greater than or equal to 60
Beschrijving

karnofsky

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
anc greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and cd4 count greater than or equal to 400/microliters.
Beschrijving

anc, platelet count, cd4 count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0243009
expected survival of 3 months or more
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
18 years of age and older
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
have given a written consent and been informed about the investigational nature of the study.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
negative serology for hiv, hepatitis c, and negative for hepatitis b surface antigen
Beschrijving

hiv, hepatitis b, hepatitis c

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with cd4 count < 400/microliters, and/or with severely damaged immune functions
Beschrijving

cd4 count, immune system dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C2698595
UMLS CUI [2,1]
C0020962
UMLS CUI [2,2]
C0277785
chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks
Beschrijving

chemotherapy, immunosuppression

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021079
fever or active infection
Beschrijving

infection, fever

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0015967
liver function: total bilirubin greater than or equal to 2 x uln or ast/alt greater than or equal to 3 x uln
Beschrijving

bilirubin, ast, alt

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
renal function: patients on dialysis
Beschrijving

dialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0011946
simultaneous treatment with a second investigational drug or biologic agent
Beschrijving

medication

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C2348568

Similar models

Eligibility Multiple Myeloma NCT00083538

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma
Item
patients must have confirmed diagnosis of one of the following: smoldering or indolent multiple myeloma, multiple myeloma more than 1 year after autologous transplant and with stable disease, or multiple myeloma with cytogenetic abnormalities
boolean
C0026764 (UMLS CUI [1])
secretion
Item
patients with secretory iga or igg must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available
boolean
C0036536 (UMLS CUI [1])
karnofsky
Item
karnofsky performance score greater than or equal to 60
boolean
C0206065 (UMLS CUI [1])
anc, platelet count, cd4 count
Item
anc greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and cd4 count greater than or equal to 400/microliters.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0243009 (UMLS CUI [3])
life expectancy
Item
expected survival of 3 months or more
boolean
C0023671 (UMLS CUI [1])
age
Item
18 years of age and older
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
have given a written consent and been informed about the investigational nature of the study.
boolean
C0021430 (UMLS CUI [1])
hiv, hepatitis b, hepatitis c
Item
negative serology for hiv, hepatitis c, and negative for hepatitis b surface antigen
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
cd4 count, immune system dysfunction
Item
patients with cd4 count < 400/microliters, and/or with severely damaged immune functions
boolean
C2698595 (UMLS CUI [1])
C0020962 (UMLS CUI [2,1])
C0277785 (UMLS CUI [2,2])
chemotherapy, immunosuppression
Item
chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks
boolean
C0392920 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
infection, fever
Item
fever or active infection
boolean
C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
bilirubin, ast, alt
Item
liver function: total bilirubin greater than or equal to 2 x uln or ast/alt greater than or equal to 3 x uln
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
dialysis
Item
renal function: patients on dialysis
boolean
C0011946 (UMLS CUI [1])
medication
Item
simultaneous treatment with a second investigational drug or biologic agent
boolean
C0013227 (UMLS CUI [1])
C2348568 (UMLS CUI [2])

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