ID

13221

Description

Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00781170

Link

https://clinicaltrials.gov/show/NCT00781170

Keywords

  1. 1/24/16 1/24/16 -
Uploaded on

January 24, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00781170

Eligibility Multiple Myeloma NCT00781170

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
multiple myeloma stadium ii / iii acc. to salmon and durie
Description

multiple myeloma, tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1300072
signed informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
adequate organ function prior autologous respectively allogeneic sct
Description

organ function, sct

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C1504389
availability of hla-identical related or unrelated donor
Description

hla-identical donor

Data type

boolean

Alias
UMLS CUI [1]
C0019633
UMLS CUI [2]
C0375877
availability of at least 2 x 10^6 cd34+ cells per kg bw of recipient for the autologous sct and at least 3 x 10^6 cd34+ cells for allogeneic sct
Description

stem cell count

Data type

boolean

Alias
UMLS CUI [1]
C2019894
for mrd-sct: 18-66 years; for mud-sct: 18-55 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
at age <55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky
Description

risk factors

Data type

boolean

Alias
UMLS CUI [1]
C0035648
consent of donor to give dli
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe heart insufficiency
Description

heart insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0018801
cardiovascular diseases or severe concomitant diseases
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
active infections that need antibiotic therapy
Description

antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0003232
positive for hiv or hepatitis
Description

hiv or hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019158
malign secondary disease
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
limited liver function with total bilirubin > 1.5 uln
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
increased transaminase > 3 uln
Description

transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
increased serum creatinine > 2 mg/dl
Description

creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
pregnant or lactating women
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hypersensitivity to fludarabine or melphalan
Description

hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0059985
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0025241
participation in another trial
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Multiple Myeloma NCT00781170

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma, tumor stage
Item
multiple myeloma stadium ii / iii acc. to salmon and durie
boolean
C0026764 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
organ function, sct
Item
adequate organ function prior autologous respectively allogeneic sct
boolean
C0678852 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
hla-identical donor
Item
availability of hla-identical related or unrelated donor
boolean
C0019633 (UMLS CUI [1])
C0375877 (UMLS CUI [2])
stem cell count
Item
availability of at least 2 x 10^6 cd34+ cells per kg bw of recipient for the autologous sct and at least 3 x 10^6 cd34+ cells for allogeneic sct
boolean
C2019894 (UMLS CUI [1])
age
Item
for mrd-sct: 18-66 years; for mud-sct: 18-55 years
boolean
C0001779 (UMLS CUI [1])
risk factors
Item
at age <55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky
boolean
C0035648 (UMLS CUI [1])
informed consent
Item
consent of donor to give dli
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
heart insufficiency
Item
severe heart insufficiency
boolean
C0018801 (UMLS CUI [1])
comorbidity
Item
cardiovascular diseases or severe concomitant diseases
boolean
C0009488 (UMLS CUI [1])
antibiotics
Item
active infections that need antibiotic therapy
boolean
C0003232 (UMLS CUI [1])
hiv or hepatitis
Item
positive for hiv or hepatitis
boolean
C0019682 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
malignancy
Item
malign secondary disease
boolean
C0006826 (UMLS CUI [1])
bilirubin
Item
limited liver function with total bilirubin > 1.5 uln
boolean
C1278039 (UMLS CUI [1])
transaminases
Item
increased transaminase > 3 uln
boolean
C0002594 (UMLS CUI [1])
creatinine
Item
increased serum creatinine > 2 mg/dl
boolean
C0201976 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hypersensitivity
Item
known hypersensitivity to fludarabine or melphalan
boolean
C0020517 (UMLS CUI [1,1])
C0059985 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0025241 (UMLS CUI [2,2])
study subject participation status
Item
participation in another trial
boolean
C2348568 (UMLS CUI [1])

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