ID

18232

Description

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

Keywords

Versions (2)
  1. 10/25/16 10/25/16 -
  2. 10/26/16 10/26/16 -
Uploaded on

October 25, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT00459069

English

Eligibility Multiple Myeloma NCT00459069

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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
Description

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

Data type

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
Description

Age

Data type

boolean

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

ECOG performance status | Life Expectancy

Data type

boolean

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

Bone Marrow Involvement Percentage | Plasmacytoma Amenable Excision Under anesthesia Local

Data type

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
Description

Laboratory Results Study Protocol Adequate

Data type

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
Description

Pregnancy test negative | Contraceptive methods

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of clinically significant venous thromboembolism
Description

Venous Thromboembolism Clinical Significance

Data type

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
Description

Immunotherapy | Cell Collection Resulting in Vaccine Generation

Data type

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
Description

Chemotherapy Regimen | Therapeutic radiology procedure

Data type

boolean

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

Autoimmune Disease Clinical Significance

Data type

boolean

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

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
serious intercurrent illness
Description

Illness Serious

Data type

boolean

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

systemic steroids | Investigational New Drugs

Data type

boolean

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

Eligibility Multiple Myeloma NCT00459069

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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