ID

30879

Descripción

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT); ODM derived from: https://clinicaltrials.gov/show/NCT00985959

Link

https://clinicaltrials.gov/show/NCT00985959

Palabras clave

Versiones (1)
  1. 30/6/18 30/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

30 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00985959

Inglés

Eligibility Multiple Myeloma NCT00985959

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants diagnosed with symptomatic or nonsecretory multiple myeloma
Descripción

Multiple Myeloma Symptomatic | Non-secretory myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0456845
participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
Descripción

Chemotherapy Absent | Patients Inappropriate Hemopoietic stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0472699
participants with a measurable lesion
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
life expectancy greater than or equal to 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously received treatment for multiple myeloma
Descripción

Prior Therapy Multiple Myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0026764
greater than or equal to grade 2 peripheral neuropathy or neuropathic pain
Descripción

Peripheral Neuropathy CTCAE Grades | Neuropathy, Painful CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1850383
UMLS CUI [2,2]
C1516728
myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
Descripción

Myocardial Infarction | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Conduction system abnormalities

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0085612
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C0151236
patient is known to be seropositive for the human immunodeficiency virus (hiv), hepatitis b surface antigen-positive or active hepatitis c infection
Descripción

HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0019196
active prior malignancy diagnosed within the last 5 years
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
female participant who is pregnant or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participant is enrolled in another clinical research study and/or is receiving an investigational agent
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Multiple Myeloma NCT00985959

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic | Non-secretory myeloma
Item
participants diagnosed with symptomatic or nonsecretory multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0456845 (UMLS CUI [2])
Chemotherapy Absent | Patients Inappropriate Hemopoietic stem cell transplant
Item
participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0472699 (UMLS CUI [2,3])
Measurable Disease
Item
participants with a measurable lesion
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than or equal to 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Multiple Myeloma
Item
previously received treatment for multiple myeloma
boolean
C1514463 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades | Neuropathy, Painful CTCAE Grades
Item
greater than or equal to grade 2 peripheral neuropathy or neuropathic pain
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1850383 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Myocardial Infarction | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Conduction system abnormalities
Item
myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0085612 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0151236 (UMLS CUI [4])
HIV Seropositivity | Hepatitis B surface antigen positive | Hepatitis C
Item
patient is known to be seropositive for the human immunodeficiency virus (hiv), hepatitis b surface antigen-positive or active hepatitis c infection
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Malignant Neoplasms
Item
active prior malignancy diagnosed within the last 5 years
boolean
C0006826 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female participant who is pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs
Item
participant is enrolled in another clinical research study and/or is receiving an investigational agent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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