ID

21926

Descrição

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00401843

Link

https://clinicaltrials.gov/show/NCT00401843

Palavras-chave

Versões (1)
  1. 08/05/2017 08/05/2017 -
Transferido a

8 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00401843

Inglês

Eligibility Multiple Myeloma NCT00401843

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
measurable secretory disease defined as either serum monoclonal paraprotein, (m-protein) greater than or equal to (>=)1 gram per deciliter (g/dl) or urine monoclonal (light chain) protein (> 200 mg/24 hours)
Descrição

Measurable Disease secretion | Serum paraprotein measurement monoclonal | M Protein | Monoclonal Protein Measurement In Urine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1327616
UMLS CUI [2,1]
C0585639
UMLS CUI [2,2]
C0746619
UMLS CUI [3]
C0700271
UMLS CUI [4,1]
C2984963
UMLS CUI [4,2]
C0042037
documented disease progression after at least 1 prior line of therapy but no more than 3 or have had no response to previous treatment (primary refractory disease)
Descrição

Disease Progression | Therapeutic procedure Quantity | Refractory Disease Primary

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1514815
UMLS CUI [3,2]
C0205225
ecog performance status score of less than or equal to (<=) 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver, and renal function
Descrição

Bone Marrow function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior treatment with bortezomib
Descrição

bortezomib

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1176309
not refractory to high-dose dexamethasone
Descrição

Dexamethasone High dose | Refractory Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C1514815
not >= grade 2 peripheral neuropathy
Descrição

Peripheral Neuropathy CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
have not received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
Descrição

Allogeneic bone marrow transplantation | Allogeneic peripheral blood stem cell transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C1960580
no prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for <= 3 years
Descrição

Malignant Neoplasm | Multiple Myeloma | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix | Malignant Neoplasm Disease Free of

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0026764
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
UMLS CUI [5]
C0851140
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
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Similar models

Eligibility Multiple Myeloma NCT00401843

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Measurable Disease secretion | Serum paraprotein measurement monoclonal | M Protein | Monoclonal Protein Measurement In Urine
Item
measurable secretory disease defined as either serum monoclonal paraprotein, (m-protein) greater than or equal to (>=)1 gram per deciliter (g/dl) or urine monoclonal (light chain) protein (> 200 mg/24 hours)
boolean
C1513041 (UMLS CUI [1,1])
C1327616 (UMLS CUI [1,2])
C0585639 (UMLS CUI [2,1])
C0746619 (UMLS CUI [2,2])
C0700271 (UMLS CUI [3])
C2984963 (UMLS CUI [4,1])
C0042037 (UMLS CUI [4,2])
Disease Progression | Therapeutic procedure Quantity | Refractory Disease Primary
Item
documented disease progression after at least 1 prior line of therapy but no more than 3 or have had no response to previous treatment (primary refractory disease)
boolean
C0242656 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1514815 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status score of less than or equal to (<=) 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
bortezomib
Item
no prior treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
Dexamethasone High dose | Refractory Disease
Item
not refractory to high-dose dexamethasone
boolean
C0011777 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C1514815 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
not >= grade 2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Allogeneic bone marrow transplantation | Allogeneic peripheral blood stem cell transplant
Item
have not received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
boolean
C0149615 (UMLS CUI [1])
C1960580 (UMLS CUI [2])
Malignant Neoplasm | Multiple Myeloma | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix | Malignant Neoplasm Disease Free of
Item
no prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for <= 3 years
boolean
C0006826 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5])
C0006826 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
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