ID

33907

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.01.19 07.01.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Januar 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Multiple Myeloma in Relapse NCT01394354

Englisch

Eligibility Multiple Myeloma in Relapse NCT01394354

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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%
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
adequate bm function
Beschreibung

Bone Marrow function

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Vorinostat | Histone deacetylase inhibitor

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Neuropathy Pre-existing CTCAE Grades

Datentyp

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
Beschreibung

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Multiple Myeloma in Relapse NCT01394354

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video