ID

24645

Description

Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates; ODM derived from: https://clinicaltrials.gov/show/NCT00577642

Lien

https://clinicaltrials.gov/show/NCT00577642

Mots-clés

Versions (1)
  1. 10/08/2017 10/08/2017 -
Téléchargé le

10 août 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00577642

Anglais

Eligibility Multiple Myeloma NCT00577642

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women 18 years of age or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of multiple myeloma(mm) by durie and dalmon staging criteria on iv bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
Description

Multiple Myeloma Staging system | Diphosphonates Intravenous | pamidronate | zoledronic acid

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0449394
UMLS CUI [2,1]
C0012544
UMLS CUI [2,2]
C1522726
UMLS CUI [3]
C0043603
UMLS CUI [4]
C0257685
mm patients in either cr or pr by ebmt criteria
Description

Multiple Myeloma In complete remission | Multiple Myeloma partial response

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0677874
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C1521726
ecog performance status of 0-2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mm patients on active anti-mm therapy (maintenance regimens allowed)
Description

Therapeutic procedure Multiple Myeloma | Maintenance treatment allowed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C0814469
UMLS CUI [2,2]
C0683607
renal failure with serum creatinine >2mg/dl and/or creatinine clearance of <30ml/min
Description

Kidney Failure | Creatinine measurement, serum | Creatinine clearance measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
relapsed, refractory or progressive disease
Description

Recurrent disease | Refractory Disease | Progressive Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3]
C1335499
any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
Description

Condition At risk Patient | Situation At risk Patient | Condition Interferes with Research results | Situation Interferes with Research results | Condition Interferes with Study Subject Participation Status | Situation Interferes with Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
hypersensitivity or any contraindication to a single dose of zoledronic acid
Description

Hypersensitivity Zoledronic acid Dose Single | Medical contraindication Zoledronic acid Dose Single

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0257685
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205171
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0257685
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205171
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Similar models

Eligibility Multiple Myeloma NCT00577642

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma Staging system | Diphosphonates Intravenous | pamidronate | zoledronic acid
Item
confirmed diagnosis of multiple myeloma(mm) by durie and dalmon staging criteria on iv bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
boolean
C0026764 (UMLS CUI [1,1])
C0449394 (UMLS CUI [1,2])
C0012544 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0043603 (UMLS CUI [3])
C0257685 (UMLS CUI [4])
Multiple Myeloma In complete remission | Multiple Myeloma partial response
Item
mm patients in either cr or pr by ebmt criteria
boolean
C0026764 (UMLS CUI [1,1])
C0677874 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C1521726 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Multiple Myeloma | Maintenance treatment allowed
Item
mm patients on active anti-mm therapy (maintenance regimens allowed)
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0814469 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Kidney Failure | Creatinine measurement, serum | Creatinine clearance measurement
Item
renal failure with serum creatinine >2mg/dl and/or creatinine clearance of <30ml/min
boolean
C0035078 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Recurrent disease | Refractory Disease | Progressive Disease
Item
relapsed, refractory or progressive disease
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
Condition At risk Patient | Situation At risk Patient | Condition Interferes with Research results | Situation Interferes with Research results | Condition Interferes with Study Subject Participation Status | Situation Interferes with Study Subject Participation Status
Item
any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
Hypersensitivity Zoledronic acid Dose Single | Medical contraindication Zoledronic acid Dose Single
Item
hypersensitivity or any contraindication to a single dose of zoledronic acid
boolean
C0020517 (UMLS CUI [1,1])
C0257685 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
C1301624 (UMLS CUI [2,1])
C0257685 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205171 (UMLS CUI [2,4])
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