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

Link

https://clinicaltrials.gov/show/NCT01394354

Keywords

Versions (1)
  1. 1/7/19 1/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 7, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Multiple Myeloma in Relapse NCT01394354

English

Eligibility Multiple Myeloma in Relapse NCT01394354

1 forms  
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

Data type

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

Data type

boolean

Alias
UMLS CUI [1]
C0206065
adequate bm function
Description

Bone Marrow function

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
Back to the top of the page

Similar models

Eligibility Multiple Myeloma in Relapse NCT01394354

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial