ID

24630

Beschreibung

Bortezomib and High-dose Melphalan at Myeloma Relapse; ODM derived from: https://clinicaltrials.gov/show/NCT00508209

Link

https://clinicaltrials.gov/show/NCT00508209

Stichworte

Versionen (1)
  1. 10.08.17 10.08.17 -
Hochgeladen am

10. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00508209

Englisch

Eligibility Multiple Myeloma NCT00508209

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
first relapse after asct
Beschreibung

Autologous hematopoietic stem cell transplant Status post | First Relapse

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2193200
UMLS CUI [1,2]
C0231290
UMLS CUI [2]
C4054953
symptomatic myeloma
Beschreibung

Myeloma Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
more than 2,0 x 10^6 cd34+ stem cells / kg bodyweight in the freezer for stem cell support
Beschreibung

Stem cells CD34 positive Available | Stem cells Support

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038250
UMLS CUI [1,2]
C0882849
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0038250
UMLS CUI [2,2]
C1521721
signed informed consent given prior to any study related activities have been performed
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age > 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
allogeneic transplantation scheduled as a part of the treatment
Beschreibung

Homologous Transplantation Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040739
UMLS CUI [1,2]
C0205539
expected survival of less than one month.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
performance status (who) > 3
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
neuropathy > grade 3 (neurological symptoms interfering with adl)
Beschreibung

Neuropathy CTCAE Grades | Neurologic Symptoms Interfere with Activities of Daily Living

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0235031
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0001288
non-secreting myeloma
Beschreibung

Non-secretory myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0456845
other concurrent disease making bortezomib treatment unsuitable
Beschreibung

Comorbidity | Bortezomib Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1176309
UMLS CUI [2,2]
C1548788
positive pregnancy test (only applicable for women with childbearing potential)
Beschreibung

Childbearing Potential Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used
Beschreibung

Melphalan allergy | Melphalan allergy Suspected | Intolerance to Melphalan | Intolerance to Melphalan Suspected | Dexamethasone allergy | Dexamethasone allergy Suspected | Intolerance to Dexamethasone | Intolerance to Dexamethasone Suspected | Hypersensitivity Boron | Hypersensitivity Boron Suspected | Intolerance to Boron | Intolerance to Boron Suspected | Mannitol allergy | Mannitol allergy Suspected | Intolerance to Mannitol | Intolerance to Mannitol Suspected | Heparin allergy | Heparin allergy Suspected | Intolerance Heparin | Intolerance to Heparin Suspected | Indwelling Catheter Use of

Datentyp

boolean

Alias
UMLS CUI [1]
C0570673
UMLS CUI [2,1]
C0570673
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0025241
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0025241
UMLS CUI [4,3]
C0750491
UMLS CUI [5]
C0571611
UMLS CUI [6,1]
C0571611
UMLS CUI [6,2]
C0750491
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0011777
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0011777
UMLS CUI [8,3]
C0750491
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0006030
UMLS CUI [10,1]
C0020517
UMLS CUI [10,2]
C0006030
UMLS CUI [10,3]
C0750491
UMLS CUI [11,1]
C1744706
UMLS CUI [11,2]
C0006030
UMLS CUI [12,1]
C1744706
UMLS CUI [12,2]
C0006030
UMLS CUI [12,3]
C0750491
UMLS CUI [13]
C0571922
UMLS CUI [14,1]
C0571922
UMLS CUI [14,2]
C0750491
UMLS CUI [15,1]
C1744706
UMLS CUI [15,2]
C0024730
UMLS CUI [16,1]
C1744706
UMLS CUI [16,2]
C0024730
UMLS CUI [16,3]
C0750491
UMLS CUI [17]
C0571776
UMLS CUI [18,1]
C0571776
UMLS CUI [18,2]
C0750491
UMLS CUI [19,1]
C1744706
UMLS CUI [19,2]
C0019134
UMLS CUI [20,1]
C1744706
UMLS CUI [20,2]
C0019134
UMLS CUI [20,3]
C0750491
UMLS CUI [21,1]
C0007439
UMLS CUI [21,2]
C1524063
uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, new york heart association (nyha) class iii or iv heart failure (attachment 6, nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Beschreibung

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Cardiac amyloidosis

Datentyp

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]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0265122
UMLS CUI [7]
C0268407
history of hypotension or has decreased blood pressure (sitting systolic blood pressure [sbp] <= 100 mmhg and/or sitting diastolic blood pressure [dbp] <= 60 mmhg)
Beschreibung

Hypotension | Decreased Blood Pressure | Sitting systolic blood pressure | Sitting diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C2917141
UMLS CUI [3]
C1319893
UMLS CUI [4]
C1319894
serious medical or psychiatric illness likely to interfere with participation in this clinical study
Beschreibung

Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study
Beschreibung

Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00508209

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Autologous hematopoietic stem cell transplant Status post | First Relapse
Item
first relapse after asct
boolean
C2193200 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C4054953 (UMLS CUI [2])
Myeloma Symptomatic
Item
symptomatic myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Stem cells CD34 positive Available | Stem cells Support
Item
more than 2,0 x 10^6 cd34+ stem cells / kg bodyweight in the freezer for stem cell support
boolean
C0038250 (UMLS CUI [1,1])
C0882849 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0038250 (UMLS CUI [2,1])
C1521721 (UMLS CUI [2,2])
Informed Consent
Item
signed informed consent given prior to any study related activities have been performed
boolean
C0021430 (UMLS CUI [1])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Homologous Transplantation Scheduled
Item
allogeneic transplantation scheduled as a part of the treatment
boolean
C0040739 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Life Expectancy
Item
expected survival of less than one month.
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale
Item
performance status (who) > 3
boolean
C1298650 (UMLS CUI [1])
Neuropathy CTCAE Grades | Neurologic Symptoms Interfere with Activities of Daily Living
Item
neuropathy > grade 3 (neurological symptoms interfering with adl)
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0235031 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0001288 (UMLS CUI [2,3])
Non-secretory myeloma
Item
non-secreting myeloma
boolean
C0456845 (UMLS CUI [1])
Comorbidity | Bortezomib Inappropriate
Item
other concurrent disease making bortezomib treatment unsuitable
boolean
C0009488 (UMLS CUI [1])
C1176309 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test positive
Item
positive pregnancy test (only applicable for women with childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
Melphalan allergy | Melphalan allergy Suspected | Intolerance to Melphalan | Intolerance to Melphalan Suspected | Dexamethasone allergy | Dexamethasone allergy Suspected | Intolerance to Dexamethasone | Intolerance to Dexamethasone Suspected | Hypersensitivity Boron | Hypersensitivity Boron Suspected | Intolerance to Boron | Intolerance to Boron Suspected | Mannitol allergy | Mannitol allergy Suspected | Intolerance to Mannitol | Intolerance to Mannitol Suspected | Heparin allergy | Heparin allergy Suspected | Intolerance Heparin | Intolerance to Heparin Suspected | Indwelling Catheter Use of
Item
has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used
boolean
C0570673 (UMLS CUI [1])
C0570673 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0025241 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0025241 (UMLS CUI [4,2])
C0750491 (UMLS CUI [4,3])
C0571611 (UMLS CUI [5])
C0571611 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0011777 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0011777 (UMLS CUI [8,2])
C0750491 (UMLS CUI [8,3])
C0020517 (UMLS CUI [9,1])
C0006030 (UMLS CUI [9,2])
C0020517 (UMLS CUI [10,1])
C0006030 (UMLS CUI [10,2])
C0750491 (UMLS CUI [10,3])
C1744706 (UMLS CUI [11,1])
C0006030 (UMLS CUI [11,2])
C1744706 (UMLS CUI [12,1])
C0006030 (UMLS CUI [12,2])
C0750491 (UMLS CUI [12,3])
C0571922 (UMLS CUI [13])
C0571922 (UMLS CUI [14,1])
C0750491 (UMLS CUI [14,2])
C1744706 (UMLS CUI [15,1])
C0024730 (UMLS CUI [15,2])
C1744706 (UMLS CUI [16,1])
C0024730 (UMLS CUI [16,2])
C0750491 (UMLS CUI [16,3])
C0571776 (UMLS CUI [17])
C0571776 (UMLS CUI [18,1])
C0750491 (UMLS CUI [18,2])
C1744706 (UMLS CUI [19,1])
C0019134 (UMLS CUI [19,2])
C1744706 (UMLS CUI [20,1])
C0019134 (UMLS CUI [20,2])
C0750491 (UMLS CUI [20,3])
C0007439 (UMLS CUI [21,1])
C1524063 (UMLS CUI [21,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Disorder of pericardium | Cardiac amyloidosis
Item
uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, new york heart association (nyha) class iii or iv heart failure (attachment 6, nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
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])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0002962 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0265122 (UMLS CUI [6])
C0268407 (UMLS CUI [7])
Hypotension | Decreased Blood Pressure | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
history of hypotension or has decreased blood pressure (sitting systolic blood pressure [sbp] <= 100 mmhg and/or sitting diastolic blood pressure [dbp] <= 60 mmhg)
boolean
C0020649 (UMLS CUI [1])
C2917141 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
C1319894 (UMLS CUI [4])
Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Investigational New Drugs | Investigational Medical Device
Item
have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
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