ID

30847

Descrição

Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00560352

Link

https://clinicaltrials.gov/show/NCT00560352

Palavras-chave

Versões (2)
  1. 26/06/2018 26/06/2018 -
  2. 26/06/2018 26/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de junho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00560352

Inglês

Eligibility Multiple Myeloma NCT00560352

1 Formulários  
Criteria
Descrição

Criteria

confirmed diagnosis of multiple myeloma with measurable disease
Descrição

Multiple Myeloma | Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1513041
evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma
Descrição

Recurrent disease | Refractory Disease | Prior Therapy Quantity Multiple Myeloma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0026764
eastern cooperative oncology group performance status of 0 - 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
last treatment for multiple myeloma not within 21 days prior to study treatment initiation
Descrição

Therapeutic procedure In the past Multiple Myeloma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C0026764
bone marrow transplant not within 3 months prior to study treatment initiation
Descrição

Bone Marrow Transplantation In the past

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005961
UMLS CUI [1,2]
C1444637
required baseline hematology and chemistry parameters.
Descrição

Hematology Parameters Required | Chemistry Parameters Required

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0200627
UMLS CUI [1,2]
C0449381
UMLS CUI [1,3]
C1514873
UMLS CUI [2,1]
C0201682
UMLS CUI [2,2]
C0449381
UMLS CUI [2,3]
C1514873
key exclusion criteria:
Descrição

Exclusion Criteria Main

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
clinically significant cardiac disease (new york heart association class iii or iv)
Descrição

Heart Disease New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
abnormal qt interval corrected for heart rate using fridericia's formula prolonged (>450 msec) after electrolytes have been corrected on baseline electrocardiogram
Descrição

Electrocardiogram QT corrected interval prolonged Fridericia formula

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0855333
UMLS CUI [1,2]
C4037934
malabsorption syndrome or uncontrolled gastrointestinal toxicities
Descrição

Malabsorption Syndrome | Gastrointestinal toxicity Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C1142499
UMLS CUI [2,2]
C0205318
dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
Descrição

Dementia Study Subject Participation Status At risk | Medical condition chronic Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C0870281
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
clinically significant pleural effusion in the previous 12 months or current ascites
Descrição

Pleural effusion | Ascites

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003962
clinically significant coagulation or platelet function disorder
Descrição

Blood Coagulation Disorders | Impaired platelet function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C3550794
intolerance to dasatinib and/or bortezomib
Descrição

Intolerance to Dasatinib | Intolerance to Bortezomib

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1455147
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1176309
acute diffuse infiltrative pulmonary disease
Descrição

Acute diffuse infiltrative lung disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1735346
prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated stage i or ii cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.
Descrição

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C3258246
UMLS CUI [4,4]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0677874
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0012634
UMLS CUI [7,3]
C0332296
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Similar models

Eligibility Multiple Myeloma NCT00560352

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Multiple Myeloma | Measurable Disease
Item
confirmed diagnosis of multiple myeloma with measurable disease
boolean
C0026764 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Recurrent disease | Refractory Disease | Prior Therapy Quantity Multiple Myeloma
Item
evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0026764 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Therapeutic procedure In the past Multiple Myeloma
Item
last treatment for multiple myeloma not within 21 days prior to study treatment initiation
boolean
C0087111 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Bone Marrow Transplantation In the past
Item
bone marrow transplant not within 3 months prior to study treatment initiation
boolean
C0005961 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
Hematology Parameters Required | Chemistry Parameters Required
Item
required baseline hematology and chemistry parameters.
boolean
C0200627 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0201682 (UMLS CUI [2,1])
C0449381 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Heart Disease New York Heart Association Classification
Item
clinically significant cardiac disease (new york heart association class iii or iv)
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Electrocardiogram QT corrected interval prolonged Fridericia formula
Item
abnormal qt interval corrected for heart rate using fridericia's formula prolonged (>450 msec) after electrolytes have been corrected on baseline electrocardiogram
boolean
C0855333 (UMLS CUI [1,1])
C4037934 (UMLS CUI [1,2])
Malabsorption Syndrome | Gastrointestinal toxicity Uncontrolled
Item
malabsorption syndrome or uncontrolled gastrointestinal toxicities
boolean
C0024523 (UMLS CUI [1])
C1142499 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Dementia Study Subject Participation Status At risk | Medical condition chronic Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
Item
dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
boolean
C0497327 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C0870281 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
Pleural effusion | Ascites
Item
clinically significant pleural effusion in the previous 12 months or current ascites
boolean
C0032227 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
Blood Coagulation Disorders | Impaired platelet function
Item
clinically significant coagulation or platelet function disorder
boolean
C0005779 (UMLS CUI [1])
C3550794 (UMLS CUI [2])
Intolerance to Dasatinib | Intolerance to Bortezomib
Item
intolerance to dasatinib and/or bortezomib
boolean
C1744706 (UMLS CUI [1,1])
C1455147 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1176309 (UMLS CUI [2,2])
Acute diffuse infiltrative lung disease
Item
acute diffuse infiltrative pulmonary disease
boolean
C1735346 (UMLS CUI [1])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Malignant Neoplasm TNM clinical staging Treated | Exception Malignant Neoplasm In complete remission | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of
Item
prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated stage i or ii cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0677874 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
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