ID

24628

Description

Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT00461955

Link

https://clinicaltrials.gov/show/NCT00461955

Keywords

Versions (1)
  1. 8/10/17 8/10/17 -
Uploaded on

August 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00461955

English

Eligibility Multiple Myeloma NCT00461955

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient between 18 and 65 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of multiple myeloma, requiring a treatment, including high dose melphalan whith autologous peripheral blood stem cell transplantation
Description

Multiple Myeloma Treatment required for | Melphalan High dose | Autologous peripheral blood stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0025241
UMLS CUI [2,2]
C0444956
UMLS CUI [3]
C1960579
performance status: < 2 (karnofsky > 70%)
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
anticipated survival > 3 month
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
collection of a minimum of 10x106 cells (cd34+)/kg of autologous g-csf mobilised peripheral blood stem cells in 2 to 3 pheresis.
Description

Collection Cell positive for CD34 antigen | G-CSF Mobilized Peripheral Blood Stem Cell Autologous | Pheresis Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0882849
UMLS CUI [2,1]
C0079459
UMLS CUI [2,2]
C2698236
UMLS CUI [2,3]
C0439859
UMLS CUI [3,1]
C0005791
UMLS CUI [3,2]
C1265611
signed and dated informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
multiple myeloma not requiring a treatment
Description

Multiple Myeloma Unnecessary Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1710572
another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
Description

Malignant Neoplasms | Mental disorder Progressing

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205329
positive serology for hiv, hepatitis c or hepatitis b
Description

HIV Seropositivity | Hepatitis C serology test Positive | HEPATITIS B SEROLOGY POSITIVE

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0850489
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0744838
hepato cellular insufficiency
Description

Insufficiency Hepatocellular

Data type

boolean

Alias
UMLS CUI [1,1]
C0231179
UMLS CUI [1,2]
C2697585
severe renal insufficiency defined by a creatine clearance < 30 ml/mn
Description

Renal Insufficiency Severe | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
women pregnant or nursing, or effective absence of contraception
Description

Pregnancy | Breast Feeding | Gender Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
antecedent of serious cardiac disease in the last 6 months.
Description

Heart Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
allergy known to the products derived from escherichia coli
Description

Hypersensitivity Product Escherichia coli Derived

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0014834
UMLS CUI [1,4]
C1441547
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Similar models

Eligibility Multiple Myeloma NCT00461955

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient between 18 and 65 years of age
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma Treatment required for | Melphalan High dose | Autologous peripheral blood stem cell transplant
Item
diagnosis of multiple myeloma, requiring a treatment, including high dose melphalan whith autologous peripheral blood stem cell transplantation
boolean
C0026764 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0025241 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C1960579 (UMLS CUI [3])
Karnofsky Performance Status
Item
performance status: < 2 (karnofsky > 70%)
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
anticipated survival > 3 month
boolean
C0023671 (UMLS CUI [1])
Collection Cell positive for CD34 antigen | G-CSF Mobilized Peripheral Blood Stem Cell Autologous | Pheresis Quantity
Item
collection of a minimum of 10x106 cells (cd34+)/kg of autologous g-csf mobilised peripheral blood stem cells in 2 to 3 pheresis.
boolean
C0200345 (UMLS CUI [1,1])
C0882849 (UMLS CUI [1,2])
C0079459 (UMLS CUI [2,1])
C2698236 (UMLS CUI [2,2])
C0439859 (UMLS CUI [2,3])
C0005791 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Informed Consent
Item
signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple Myeloma Unnecessary Therapy
Item
multiple myeloma not requiring a treatment
boolean
C0026764 (UMLS CUI [1,1])
C1710572 (UMLS CUI [1,2])
Malignant Neoplasms | Mental disorder Progressing
Item
another cancer in the 5 years preceding the diagnosis or evolutive psychiatric affection
boolean
C0006826 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis C serology test Positive | HEPATITIS B SEROLOGY POSITIVE
Item
positive serology for hiv, hepatitis c or hepatitis b
boolean
C0019699 (UMLS CUI [1])
C0850489 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0744838 (UMLS CUI [3])
Insufficiency Hepatocellular
Item
hepato cellular insufficiency
boolean
C0231179 (UMLS CUI [1,1])
C2697585 (UMLS CUI [1,2])
Renal Insufficiency Severe | Creatinine clearance measurement
Item
severe renal insufficiency defined by a creatine clearance < 30 ml/mn
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Absent
Item
women pregnant or nursing, or effective absence of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Heart Disease Serious
Item
antecedent of serious cardiac disease in the last 6 months.
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Hypersensitivity Product Escherichia coli Derived
Item
allergy known to the products derived from escherichia coli
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0014834 (UMLS CUI [1,3])
C1441547 (UMLS CUI [1,4])
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