ID

33907

Description

Vorinostat in Combination With Bortezomib, Doxorubicin and Dexamethasone (VBDD) in Patients With Refractory or Relapsed Multiple Myeloma (MM); ODM derived from: https://clinicaltrials.gov/show/NCT01394354

Lien

https://clinicaltrials.gov/show/NCT01394354

Mots-clés

Versions (1)
  1. 07/01/2019 07/01/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 janvier 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Multiple Myeloma in Relapse NCT01394354

Anglais

Eligibility Multiple Myeloma in Relapse NCT01394354

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with refractory or relapsed mm after at least first-line chemotherapy (ctx) or pbsct (autologous and allogeneic sct). all lines of relapse are eligible.
Description

Refractory plasma cell neoplasm | Plasma cell myeloma recurrent | Status post First line Chemotherapy | Status post Peripheral Stem Cell Transplantation | Status post Transplantation of autologous hematopoietic stem cell | Status post Allogeneic Stem Cell Transplantation

Type de données

boolean

Alias
UMLS CUI [1]
C0278620
UMLS CUI [2]
C1370446
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1708063
UMLS CUI [3,3]
C0392920
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0242602
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C1831743
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C2242529
kps ≥60%
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
adequate bm function
Description

Bone Marrow function

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
adequate hepatic and renal function (ast and alt ≤2.5 times uln, bilirubin ≤1.5 times uln, egfr >20 ml/min)
Description

Liver function | Renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Estimated Glomerular Filtration Rate

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C1278039
UMLS CUI [6]
C3811844
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has had prior treatment with vorinostat or hdac inhibitors
Description

Vorinostat | Histone deacetylase inhibitor

Type de données

boolean

Alias
UMLS CUI [1]
C0672708
UMLS CUI [2]
C1512474
patients with severe hepatic impairment or acute diffuse infiltrative pulmonary and pericardial disease
Description

Hepatic impairment Severe | Diffuse infiltrative lung disease | Disorder of pericardium Diffusely infiltrative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0340110
UMLS CUI [3,1]
C0265122
UMLS CUI [3,2]
C3842356
patient has preexisting nci ctc ≥grade 3 neuropathy
Description

Neuropathy Pre-existing CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
patient with known cns mm-involvement and/or mm-related/induced meningitis
Description

Central Nervous System Involvement with Multiple Myeloma | Meningitis Multiple Myeloma Related | Meningitis Multiple Myeloma Induced

Type de données

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C0025289
UMLS CUI [2,2]
C0026764
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0025289
UMLS CUI [3,2]
C0026764
UMLS CUI [3,3]
C0205263
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Similar models

Eligibility Multiple Myeloma in Relapse NCT01394354

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Refractory plasma cell neoplasm | Plasma cell myeloma recurrent | Status post First line Chemotherapy | Status post Peripheral Stem Cell Transplantation | Status post Transplantation of autologous hematopoietic stem cell | Status post Allogeneic Stem Cell Transplantation
Item
patients with refractory or relapsed mm after at least first-line chemotherapy (ctx) or pbsct (autologous and allogeneic sct). all lines of relapse are eligible.
boolean
C0278620 (UMLS CUI [1])
C1370446 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0242602 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C1831743 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C2242529 (UMLS CUI [6,2])
Karnofsky Performance Status
Item
kps ≥60%
boolean
C0206065 (UMLS CUI [1])
Bone Marrow function
Item
adequate bm function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Liver function | Renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Estimated Glomerular Filtration Rate
Item
adequate hepatic and renal function (ast and alt ≤2.5 times uln, bilirubin ≤1.5 times uln, egfr >20 ml/min)
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C3811844 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Vorinostat | Histone deacetylase inhibitor
Item
patient has had prior treatment with vorinostat or hdac inhibitors
boolean
C0672708 (UMLS CUI [1])
C1512474 (UMLS CUI [2])
Hepatic impairment Severe | Diffuse infiltrative lung disease | Disorder of pericardium Diffusely infiltrative
Item
patients with severe hepatic impairment or acute diffuse infiltrative pulmonary and pericardial disease
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0340110 (UMLS CUI [2])
C0265122 (UMLS CUI [3,1])
C3842356 (UMLS CUI [3,2])
Neuropathy Pre-existing CTCAE Grades
Item
patient has preexisting nci ctc ≥grade 3 neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Central Nervous System Involvement with Multiple Myeloma | Meningitis Multiple Myeloma Related | Meningitis Multiple Myeloma Induced
Item
patient with known cns mm-involvement and/or mm-related/induced meningitis
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0025289 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0025289 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C0205263 (UMLS CUI [3,3])
Retour au début de la page 

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