ID

36451

Beskrivning

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02416206

Länk

https://clinicaltrials.gov/show/NCT02416206

Nyckelord

Versioner (1)
  1. 2019-05-15 2019-05-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02416206

Engelsk

Eligibility Multiple Myeloma NCT02416206

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 18 - 70 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky status ≥ 70%
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
diagnosis of multiple myeloma
Beskrivning

Multiple Myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
within 9 months of the start of induction chemotherapy and no evidence of relapse or progression.
Beskrivning

Induction Chemotherapy | Relapse Absent | Disease Progression Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C3179010
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0332197
availability of cryopreserved peripheral blood stem cells with a cd34 dose of at least 2x106/kg.
Beskrivning

Peripheral Blood Stem Cells Cryopreserved CD34 dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1518999
UMLS CUI [1,2]
C0010405
UMLS CUI [1,3]
C4038498
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
poor cardiac function: left ventricular ejection fraction <40%
Beskrivning

Cardiac function Poor | Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0428772
poor pulmonary function: fev1, fvc, or dlco <40% predicted
Beskrivning

Pulmonary function Poor | FEV1 | FVC | Percent Predicted DLCO

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3714541
UMLS CUI [4]
C4054207
poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, gilbert's or primary malignancy), ast/alt > 3x uln
Beskrivning

Liver function Poor | Serum total bilirubin measurement | Independent of Hemolysis | Independent of Gilbert Disease | Independent of Primary tumor | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0019054
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0017551
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0677930
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0151905
poor renal function: creatinine >2.0 mg/dl or creatinine clearance < 40 ml/min (calculated creatinine clearance is permitted)
Beskrivning

Renal function Poor | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4]
C2711451
ongoing or active systemic infection, active hepatitis b or c virus infection, or known human immunodeficiency virus (hiv) positive.
Beskrivning

Sepsis | Hepatitis B | Hepatitis C | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019699
women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
Beskrivning

Pregnancy | Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
Beskrivning

Debilitation Disease | Debilitation Mental disorder | Informed Consent Excluded | Therapy Optimal Excluded | Follow-up Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0742985
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0742985
UMLS CUI [2,2]
C0004936
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C2698651
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C3274571
UMLS CUI [5,2]
C0332196
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Similar models

Eligibility Multiple Myeloma NCT02416206

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 18 - 70 years
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky status ≥ 70%
boolean
C0206065 (UMLS CUI [1])
Multiple Myeloma
Item
diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Induction Chemotherapy | Relapse Absent | Disease Progression Absent
Item
within 9 months of the start of induction chemotherapy and no evidence of relapse or progression.
boolean
C3179010 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Peripheral Blood Stem Cells Cryopreserved CD34 dose
Item
availability of cryopreserved peripheral blood stem cells with a cd34 dose of at least 2x106/kg.
boolean
C1518999 (UMLS CUI [1,1])
C0010405 (UMLS CUI [1,2])
C4038498 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cardiac function Poor | Left ventricular ejection fraction
Item
poor cardiac function: left ventricular ejection fraction <40%
boolean
C0232164 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
Pulmonary function Poor | FEV1 | FVC | Percent Predicted DLCO
Item
poor pulmonary function: fev1, fvc, or dlco <40% predicted
boolean
C0231921 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C4054207 (UMLS CUI [4])
Liver function Poor | Serum total bilirubin measurement | Independent of Hemolysis | Independent of Gilbert Disease | Independent of Primary tumor | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, gilbert's or primary malignancy), ast/alt > 3x uln
boolean
C0232741 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0332291 (UMLS CUI [3,1])
C0019054 (UMLS CUI [3,2])
C0332291 (UMLS CUI [4,1])
C0017551 (UMLS CUI [4,2])
C0332291 (UMLS CUI [5,1])
C0677930 (UMLS CUI [5,2])
C0151904 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
Renal function Poor | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
poor renal function: creatinine >2.0 mg/dl or creatinine clearance < 40 ml/min (calculated creatinine clearance is permitted)
boolean
C0232804 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C2711451 (UMLS CUI [4])
Sepsis | Hepatitis B | Hepatitis C | HIV Seropositivity
Item
ongoing or active systemic infection, active hepatitis b or c virus infection, or known human immunodeficiency virus (hiv) positive.
boolean
C0243026 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Debilitation Disease | Debilitation Mental disorder | Informed Consent Excluded | Therapy Optimal Excluded | Follow-up Excluded
Item
patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
boolean
C0742985 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0742985 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C2698651 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C3274571 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
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