ID

21963

Descripción

Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT00804947

Link

https://clinicaltrials.gov/show/NCT00804947

Palabras clave

Versiones (1)
  1. 10/5/17 10/5/17 -
Subido en

10 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00804947

Inglés

Eligibility Multiple Myeloma NCT00804947

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic multiple myeloma
Descripción

Multiple Myeloma Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
male or female subject age >= 70 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
the subject has received at least one previous line of therapy including:
Descripción

Therapeutic procedure Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
front-line treatment with vbmcp/vbad or vad or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide
Descripción

First line treatment | VBMCP protocol | VBAD protocol | VAD regimen | Second line treatment | bortezomib | Thalidomide | lenalidomide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2]
C0950525
UMLS CUI [3]
C0379779
UMLS CUI [4]
C0077975
UMLS CUI [5]
C1710038
UMLS CUI [6]
C1176309
UMLS CUI [7]
C0039736
UMLS CUI [8]
C1144149
the subject has given voluntary written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of bortezomib, thalidomide or lenalidomide as front-line therapy
Descripción

First line treatment | bortezomib | Thalidomide | lenalidomide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2]
C1176309
UMLS CUI [3]
C0039736
UMLS CUI [4]
C1144149
ecog satus >=2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction <40%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
dlco and fvc <39% theoretical value
Descripción

Carbon Monoxide Diffusing Capability Test | Forced vital capacity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516251
UMLS CUI [2]
C1287681
abnormal liver function(total bilirubin > 2 mg/dl and/or alt or ast > 3 x uln)
Descripción

Liver Dysfunction | Serum total bilirubin measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
serum creatinine at transplant >1.6 mg/dl and/or creatinine clearance < 65 ml/minute
Descripción

Serum creatinine measurement Transplantation | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0040732
UMLS CUI [2]
C0373595
subject has an active systemic infection requiring treatment
Descripción

Sepsis Treatment required for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0332121
subject had a myocardial infarction within 6 months of enrollment or has nyha class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias
Descripción

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0421196
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0205082
subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol
Descripción

Medical condition Serious Interferes with Treatment completion | Hepatic impairment Severe | Disorder of pericardium | Acute diffuse infiltrative lung disease | Mental disorder Interferes with Treatment completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0580352
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0265122
UMLS CUI [4]
C1735346
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0580352
subject is known to be immunodeficiency virus (hiv)-positive
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment
Descripción

Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
if female, the subject is pregnant or breast-feeding. confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. pregnancy testing is not required for postmenopausal or surgically sterilized women
Descripción

Pregnancy | Breast Feeding | Gender Pregnancy test negative | Postmenopausal state | Female Sterilization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0427780
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0015787
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Similar models

Eligibility Multiple Myeloma NCT00804947

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic
Item
symptomatic multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Age
Item
male or female subject age >= 70 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Quantity
Item
the subject has received at least one previous line of therapy including:
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
First line treatment | VBMCP protocol | VBAD protocol | VAD regimen | Second line treatment | bortezomib | Thalidomide | lenalidomide
Item
front-line treatment with vbmcp/vbad or vad or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide
boolean
C1708063 (UMLS CUI [1])
C0950525 (UMLS CUI [2])
C0379779 (UMLS CUI [3])
C0077975 (UMLS CUI [4])
C1710038 (UMLS CUI [5])
C1176309 (UMLS CUI [6])
C0039736 (UMLS CUI [7])
C1144149 (UMLS CUI [8])
Informed Consent
Item
the subject has given voluntary written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
First line treatment | bortezomib | Thalidomide | lenalidomide
Item
use of bortezomib, thalidomide or lenalidomide as front-line therapy
boolean
C1708063 (UMLS CUI [1])
C1176309 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C1144149 (UMLS CUI [4])
ECOG performance status
Item
ecog satus >=2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction <40%
boolean
C0428772 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test | Forced vital capacity
Item
dlco and fvc <39% theoretical value
boolean
C1516251 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
Liver Dysfunction | Serum total bilirubin measurement | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
abnormal liver function(total bilirubin > 2 mg/dl and/or alt or ast > 3 x uln)
boolean
C0086565 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Serum creatinine measurement Transplantation | Creatinine clearance measurement
Item
serum creatinine at transplant >1.6 mg/dl and/or creatinine clearance < 65 ml/minute
boolean
C0201976 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Sepsis Treatment required for
Item
subject has an active systemic infection requiring treatment
boolean
C0243026 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Ventricular arrhythmia Uncontrolled Severe
Item
subject had a myocardial infarction within 6 months of enrollment or has nyha class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0421196 (UMLS CUI [3])
C0085612 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
Medical condition Serious Interferes with Treatment completion | Hepatic impairment Severe | Disorder of pericardium | Acute diffuse infiltrative lung disease | Mental disorder Interferes with Treatment completion
Item
subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C0948807 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0265122 (UMLS CUI [3])
C1735346 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0580352 (UMLS CUI [5,3])
HIV Seropositivity
Item
subject is known to be immunodeficiency virus (hiv)-positive
boolean
C0019699 (UMLS CUI [1])
Investigational New Drugs | Investigational Medical Device
Item
subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Pregnancy | Breast Feeding | Gender Pregnancy test negative | Postmenopausal state | Female Sterilization
Item
if female, the subject is pregnant or breast-feeding. confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. pregnancy testing is not required for postmenopausal or surgically sterilized women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
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