ID

30878

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00984828

Nyckelord

Versioner (1)
  1. 2018-06-30 2018-06-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00984828

Engelsk

Eligibility Multiple Myeloma NCT00984828

1 Formulär  
Inclusion Criteria
Beskrivning

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
Beskrivning

Age | Multiple Myeloma | Patient Appropriate Stem cell transplant

Datatyp

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
Beskrivning

Serum paraprotein measurement | Urine paraprotein measurement

Datatyp

boolean

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

ECOG performance status

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
woman of child bearing potential
Beskrivning

Childbearing Potential

Datatyp

boolean

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

Non-secretory myeloma

Datatyp

boolean

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

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

Datatyp

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)
Beskrivning

Diabetic - poor control | Antidiabetics Dose Stable

Datatyp

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
Beskrivning

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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