ID

18207

Descripción

Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00337506

Link

https://clinicaltrials.gov/show/NCT00337506

Palabras clave

Versiones (1)
  1. 25/10/16 25/10/16 -
Subido en

25 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00337506

Inglés

Eligibility Multiple Myeloma NCT00337506

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of mm according to the swog criteria (annex 1)
Descripción

Multiple Myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026764
previously untreated (localized radiotherapy is allowed)
Descripción

Multiple Myeloma untreated | Therapeutic radiology procedure Localized

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0392752
symptomatic mm stage ii or iii according to durie-salmon staging system (annex 2) or stage i with one symptomatic osteolytic lesion
Descripción

Multiple Myeloma Symptomatic | Staging | Osteolytic lesion Symptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0332305
UMLS CUI [3,1]
C0302313
UMLS CUI [3,2]
C0231220
with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (> 0.2g/24h)
Descripción

Serum paraprotein measurement | Urine paraprotein measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0585639
UMLS CUI [2]
C0585640
age < 75 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
able to understand and to given an informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. women of childbearing potential must be following adequate contraceptive measures.
Descripción

Childbearing Potential Lacking | Urine pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332268
UMLS CUI [2]
C0430057
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
no active systemic infection. in the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with velcade plus dexamethasone.
Descripción

Sepsis | Antibiotics Spectrum broad | Antibiotics Organism Specific | Fever | Vital signs Stable | Antibiotics | Velcade | Dexamethasone

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C2827424
UMLS CUI [2,3]
C0332464
UMLS CUI [3,1]
C0003232
UMLS CUI [3,2]
C0029235
UMLS CUI [3,3]
C0205369
UMLS CUI [4]
C0015967
UMLS CUI [5,1]
C0518766
UMLS CUI [5,2]
C0205360
UMLS CUI [6]
C0003232
UMLS CUI [7]
C1174739
UMLS CUI [8]
C0011777
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy < 2 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status > 2 (annex 3)
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
proven amyloidosis
Descripción

Amyloidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002726
positive hiv serology
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
antecedents of severe psychiatric disease
Descripción

Mental disorders Severe Disease antecedent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0683336
severe diabetes contraindicating the use of high-dose corticoïds
Descripción

Diabetes Mellitus Severe | Medical contraindication Adrenal Cortex Hormones High dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0444956
> nci grade 2 peripheral neuropathy (annex iv)
Descripción

Peripheral Neuropathy | CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
serum biochemical values as follow
Descripción

Serum Test Result Biochemical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205474
creatinin level > 200mmol/l
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin, transaminases or ggt > 3 the upper normal limit
Descripción

Serum total bilirubin measurement | Transaminases increased | Gamma glutamyl transferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0438717
UMLS CUI [3]
C0202035
use of any experimental drugs within 30 days of baseline
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Multiple Myeloma NCT00337506

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
diagnosis of mm according to the swog criteria (annex 1)
boolean
C0026764 (UMLS CUI [1])
Multiple Myeloma untreated | Therapeutic radiology procedure Localized
Item
previously untreated (localized radiotherapy is allowed)
boolean
C0026764 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
Multiple Myeloma Symptomatic | Staging | Osteolytic lesion Symptomatic
Item
symptomatic mm stage ii or iii according to durie-salmon staging system (annex 2) or stage i with one symptomatic osteolytic lesion
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332305 (UMLS CUI [2])
C0302313 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Serum paraprotein measurement | Urine paraprotein measurement
Item
with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (> 0.2g/24h)
boolean
C0585639 (UMLS CUI [1])
C0585640 (UMLS CUI [2])
Age
Item
age < 75 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to understand and to given an informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Lacking | Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. women of childbearing potential must be following adequate contraceptive measures.
boolean
C3831118 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0430057 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Sepsis | Antibiotics Spectrum broad | Antibiotics Organism Specific | Fever | Vital signs Stable | Antibiotics | Velcade | Dexamethasone
Item
no active systemic infection. in the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with velcade plus dexamethasone.
boolean
C0243026 (UMLS CUI [1])
C0003232 (UMLS CUI [2,1])
C2827424 (UMLS CUI [2,2])
C0332464 (UMLS CUI [2,3])
C0003232 (UMLS CUI [3,1])
C0029235 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
C0015967 (UMLS CUI [4])
C0518766 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
C0003232 (UMLS CUI [6])
C1174739 (UMLS CUI [7])
C0011777 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
life expectancy < 2 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status > 2 (annex 3)
boolean
C1520224 (UMLS CUI [1])
Amyloidosis
Item
proven amyloidosis
boolean
C0002726 (UMLS CUI [1])
HIV Seropositivity
Item
positive hiv serology
boolean
C0019699 (UMLS CUI [1])
Mental disorders Severe Disease antecedent
Item
antecedents of severe psychiatric disease
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0683336 (UMLS CUI [1,3])
Diabetes Mellitus Severe | Medical contraindication Adrenal Cortex Hormones High dose
Item
severe diabetes contraindicating the use of high-dose corticoïds
boolean
C0011849 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0444956 (UMLS CUI [2,3])
Peripheral Neuropathy | CTCAE Grades
Item
> nci grade 2 peripheral neuropathy (annex iv)
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Serum Test Result Biochemical
Item
serum biochemical values as follow
boolean
C0229671 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205474 (UMLS CUI [1,3])
Creatinine measurement, serum
Item
creatinin level > 200mmol/l
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Transaminases increased | Gamma glutamyl transferase measurement
Item
bilirubin, transaminases or ggt > 3 the upper normal limit
boolean
C1278039 (UMLS CUI [1])
C0438717 (UMLS CUI [2])
C0202035 (UMLS CUI [3])
Investigational New Drugs
Item
use of any experimental drugs within 30 days of baseline
boolean
C0013230 (UMLS CUI [1])
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