ID

30878

Description

Randomized Study of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00984828

Lien

https://clinicaltrials.gov/show/NCT00984828

Mots-clés

Versions (1)
  1. 30/06/2018 30/06/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

30 juin 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00984828

Anglais

Eligibility Multiple Myeloma NCT00984828

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
man or woman between age 18-65 with newly diagnosed multiple myeloma for whom stem cell transplantation is considered appropriate
Description

Age | Multiple Myeloma | Patient Appropriate Stem cell transplant

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0026764
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C1504389
measurable serum and/or urinary paraprotein
Description

Serum paraprotein measurement | Urine paraprotein measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0585639
UMLS CUI [2]
C0585640
european cooperative oncology group performance status 0-3
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
serum bilirubin < 1.5x the upper limit of normal (uln) serum alanine transaminase (alt)/aspartate transaminase values < 2.5 x uln
Description

Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study
Description

Informed Consent | Informed Consent Patient Representatives

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
woman of child bearing potential
Description

Childbearing Potential

Type de données

boolean

Alias
UMLS CUI [1]
C3831118
non-secretory mm
Description

Non-secretory myeloma

Type de données

boolean

Alias
UMLS CUI [1]
C0456845
serum creatinine > 400 micromol/l after initial resuscitation patients with previous grade 2-4 peripheral neuropathy
Description

Creatinine measurement, serum | Status post Resuscitation Initial | Peripheral Neuropathy CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0035273
UMLS CUI [2,3]
C0205265
UMLS CUI [3,1]
C0031117
UMLS CUI [3,2]
C1516728
uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
Description

Diabetic - poor control | Antidiabetics Dose Stable

Type de données

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or iii-iv heart failure
Description

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Angina Pectoris Uncontrolled | Disorder of pericardium | Heart failure NYHA

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0265122
UMLS CUI [6,1]
C0018801
UMLS CUI [6,2]
C1275491
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Similar models

Eligibility Multiple Myeloma NCT00984828

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Multiple Myeloma | Patient Appropriate Stem cell transplant
Item
man or woman between age 18-65 with newly diagnosed multiple myeloma for whom stem cell transplantation is considered appropriate
boolean
C0001779 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C1504389 (UMLS CUI [3,3])
Serum paraprotein measurement | Urine paraprotein measurement
Item
measurable serum and/or urinary paraprotein
boolean
C0585639 (UMLS CUI [1])
C0585640 (UMLS CUI [2])
ECOG performance status
Item
european cooperative oncology group performance status 0-3
boolean
C1520224 (UMLS CUI [1])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
serum bilirubin < 1.5x the upper limit of normal (uln) serum alanine transaminase (alt)/aspartate transaminase values < 2.5 x uln
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Informed Consent | Informed Consent Patient Representatives
Item
subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential
Item
woman of child bearing potential
boolean
C3831118 (UMLS CUI [1])
Non-secretory myeloma
Item
non-secretory mm
boolean
C0456845 (UMLS CUI [1])
Creatinine measurement, serum | Status post Resuscitation Initial | Peripheral Neuropathy CTCAE Grades
Item
serum creatinine > 400 micromol/l after initial resuscitation patients with previous grade 2-4 peripheral neuropathy
boolean
C0201976 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0035273 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0031117 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Diabetic - poor control | Antidiabetics Dose Stable
Item
uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
boolean
C0421258 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Angina Pectoris Uncontrolled | Disorder of pericardium | Heart failure NYHA
Item
uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or iii-iv heart failure
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002962 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0265122 (UMLS CUI [5])
C0018801 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
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