ID

18232

Beschreibung

The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00459069

Link

https://clinicaltrials.gov/show/NCT00459069

Stichworte

  1. 25.10.16 25.10.16 -
  2. 26.10.16 26.10.16 -
Hochgeladen am

25. Oktober 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0

Modell Kommentare :

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

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 NCT00459069

Eligibility Multiple Myeloma NCT00459069

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of multiple myeloma: stage i not requiring initiation of chemotherapy; stage i, ii or iii patients felt to be clinically stable and having received at least one prior chemotherapy regimen
Beschreibung

Multiple Myeloma | Staging | Patients Clinical Stable | Prior Chemotherapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0332305
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0205210
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C1265611
measurable disease as defined by a history of an elevated m component in plasma or urine or free kappa.lambda light chains in serum
Beschreibung

Measurable Disease | Plasma High M-component | High M-component In Urine | Serum Free kappa light chain | Serum Free lambda light chain

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C3151542
UMLS CUI [3,1]
C3151542
UMLS CUI [3,2]
C0042037
UMLS CUI [4,1]
C0229671
UMLS CUI [4,2]
C0443743
UMLS CUI [5,1]
C0229671
UMLS CUI [5,2]
C0443744
18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0-1 with a greater than nine week life expectancy
Beschreibung

ECOG performance status | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
> 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
Beschreibung

Bone Marrow Involvement Percentage | Plasmacytoma Amenable Excision Under anesthesia Local

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517677
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0032131
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C0728940
UMLS CUI [2,4]
C1720436
UMLS CUI [2,5]
C0205276
laboratory results within ranges outlined in protocol
Beschreibung

Laboratory Results Study Protocol Adequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0205411
negative pregnancy test and adequate contraception method(s) must be documented
Beschreibung

Pregnancy test negative | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of clinically significant venous thromboembolism
Beschreibung

Venous Thromboembolism Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1861172
UMLS CUI [1,2]
C2826293
received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
Beschreibung

Immunotherapy | Cell Collection Resulting in Vaccine Generation

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C0200345
UMLS CUI [2,3]
C0332294
UMLS CUI [2,4]
C0042210
UMLS CUI [2,5]
C3146294
chemotherapy or radiation therapy 4 weeks prior to the first vaccine
Beschreibung

Chemotherapy Regimen | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
clinically significant autoimmune disease
Beschreibung

Autoimmune Disease Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C2826293
hiv positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
serious intercurrent illness
Beschreibung

Illness Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
taking systemic corticosteroids within 4 weeks of treatment with study drug
Beschreibung

systemic steroids | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C0013230

Ähnliche Modelle

Eligibility Multiple Myeloma NCT00459069

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Staging | Patients Clinical Stable | Prior Chemotherapy Quantity
Item
confirmed diagnosis of multiple myeloma: stage i not requiring initiation of chemotherapy; stage i, ii or iii patients felt to be clinically stable and having received at least one prior chemotherapy regimen
boolean
C0026764 (UMLS CUI [1])
C0332305 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1514457 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Measurable Disease | Plasma High M-component | High M-component In Urine | Serum Free kappa light chain | Serum Free lambda light chain
Item
measurable disease as defined by a history of an elevated m component in plasma or urine or free kappa.lambda light chains in serum
boolean
C1513041 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C3151542 (UMLS CUI [2,2])
C3151542 (UMLS CUI [3,1])
C0042037 (UMLS CUI [3,2])
C0229671 (UMLS CUI [4,1])
C0443743 (UMLS CUI [4,2])
C0229671 (UMLS CUI [5,1])
C0443744 (UMLS CUI [5,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Life Expectancy
Item
ecog performance status of 0-1 with a greater than nine week life expectancy
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Bone Marrow Involvement Percentage | Plasmacytoma Amenable Excision Under anesthesia Local
Item
> 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
boolean
C1517677 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0032131 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C0728940 (UMLS CUI [2,3])
C1720436 (UMLS CUI [2,4])
C0205276 (UMLS CUI [2,5])
Laboratory Results Study Protocol Adequate
Item
laboratory results within ranges outlined in protocol
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Pregnancy test negative | Contraceptive methods
Item
negative pregnancy test and adequate contraception method(s) must be documented
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Venous Thromboembolism Clinical Significance
Item
history of clinically significant venous thromboembolism
boolean
C1861172 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Immunotherapy | Cell Collection Resulting in Vaccine Generation
Item
received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
boolean
C0021083 (UMLS CUI [1])
C0007634 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0332294 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C3146294 (UMLS CUI [2,5])
Chemotherapy Regimen | Therapeutic radiology procedure
Item
chemotherapy or radiation therapy 4 weeks prior to the first vaccine
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Autoimmune Disease Clinical Significance
Item
clinically significant autoimmune disease
boolean
C0004364 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Illness Serious
Item
serious intercurrent illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
systemic steroids | Investigational New Drugs
Item
taking systemic corticosteroids within 4 weeks of treatment with study drug
boolean
C2825233 (UMLS CUI [1])
C0013230 (UMLS CUI [2])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

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