ID

30924

Descripción

Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance; ODM derived from: https://clinicaltrials.gov/show/NCT02467010

Link

https://clinicaltrials.gov/show/NCT02467010

Palabras clave

Versiones (1)
  1. 3/7/18 3/7/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de julio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02467010

Inglés

Eligibility Multiple Myeloma NCT02467010

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
stage ii-iii multiple myeloma
Descripción

Multiple Myeloma Durie/Salmon Stage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C4528204
relapse or primary refractory disease after initial chemotherapy
Descripción

Recurrent disease | Refractory Disease Primary | Status post Chemotherapy Initial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0205265
who performance status 0 - 2
Descripción

WHO performance status scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
life expectancy of at least 6 weeks
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
anc (absolute neutrophil count) ≥ 1.0x109/l(or ≥ 0.5x109/l, if due to bone marrow infiltration by malignancy)
Descripción

Absolute neutrophil count | Neoplastic cell infiltration of bone marrow

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C3670598
platelet count ≥ 75x109/l or ≥ 50x109/l, if due to bone marrow infiltration by malignancy)
Descripción

Platelet Count measurement | Neoplastic cell infiltration of bone marrow

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C3670598
written informed consent (present in patient's file)
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
patient is able and willing to use adequate contraception during therapy and for at least 1 month after study
Descripción

Contraceptive methods Able | Contraceptive methods Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0600109
patient has the ability to understand the requirements of the study
Descripción

Comprehension Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with bortezomib
Descripción

Bortezomib

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1176309
urine production < 1.5 l/24h
Descripción

Urine production 24 Hour urine volume measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0683190
UMLS CUI [1,2]
C0427843
pre-existent polyneuropathy (grade 2 or higher, according to ctcae 3.0)
Descripción

Polyneuropathy Pre-existing CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0152025
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide
Descripción

Pregnancy | Pregnancy test positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin)
Descripción

Malignant Neoplasms | Exception Basal cell carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
active uncontrolled infections
Descripción

Communicable Disease Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
additional uncontrolled serious medical or psychiatric illness
Descripción

Disease Serious Uncontrolled | Serious mental illness Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0205318
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Similar models

Eligibility Multiple Myeloma NCT02467010

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma Durie/Salmon Stage
Item
stage ii-iii multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C4528204 (UMLS CUI [1,2])
Recurrent disease | Refractory Disease Primary | Status post Chemotherapy Initial
Item
relapse or primary refractory disease after initial chemotherapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0205265 (UMLS CUI [3,3])
WHO performance status scale
Item
who performance status 0 - 2
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 6 weeks
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count | Neoplastic cell infiltration of bone marrow
Item
anc (absolute neutrophil count) ≥ 1.0x109/l(or ≥ 0.5x109/l, if due to bone marrow infiltration by malignancy)
boolean
C0948762 (UMLS CUI [1])
C3670598 (UMLS CUI [2])
Platelet Count measurement | Neoplastic cell infiltration of bone marrow
Item
platelet count ≥ 75x109/l or ≥ 50x109/l, if due to bone marrow infiltration by malignancy)
boolean
C0032181 (UMLS CUI [1])
C3670598 (UMLS CUI [2])
Informed Consent
Item
written informed consent (present in patient's file)
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods Able | Contraceptive methods Willing
Item
patient is able and willing to use adequate contraception during therapy and for at least 1 month after study
boolean
C0700589 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Comprehension Study Protocol
Item
patient has the ability to understand the requirements of the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Bortezomib
Item
previous treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
Urine production 24 Hour urine volume measurement
Item
urine production < 1.5 l/24h
boolean
C0683190 (UMLS CUI [1,1])
C0427843 (UMLS CUI [1,2])
Polyneuropathy Pre-existing CTCAE Grades
Item
pre-existent polyneuropathy (grade 2 or higher, according to ctcae 3.0)
boolean
C0152025 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Pregnancy | Pregnancy test positive
Item
pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Malignant Neoplasms | Exception Basal cell carcinoma
Item
history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Communicable Disease Uncontrolled
Item
active uncontrolled infections
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Disease Serious Uncontrolled | Serious mental illness Uncontrolled
Item
additional uncontrolled serious medical or psychiatric illness
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C3841614 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
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