ID

22124

Descripción

Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00315757

Link

https://clinicaltrials.gov/show/NCT00315757

Palabras clave

Versiones (1)
  1. 20/5/17 20/5/17 -
Subido en

20 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00315757

Inglés

Eligibility Multiple Myeloma NCT00315757

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with multiple myeloma that is refractory or has relapsed after treatment
Descripción

refractory multiple myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0205269
measurable serum and/or urine m-protein
Descripción

m-protein serum, urine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C0042036
failed 1 or 2 prior therapies for multiple myeloma
Descripción

multiple myeloma failed therapies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C023117
18 years of age or older
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
received more than 2 prior therapies for multiple myeloma.
Descripción

multiple myeloma prior therapies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1514463
previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks
Descripción

previous cancer therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0920425
received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)
Descripción

monoclonal antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003250
received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks
Descripción

multiple myeloma investigational agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0013230
subjects who received a stem cell transplant using cells from themselves in the past 16 weeks
Descripción

autologous stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1831743
subjects who received a stem cell transplant using cells from another individual
Descripción

allogeneic stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2242529
previously treated with bortezomib or mapatumumab
Descripción

bortezomib, mapatumumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C1665688
known hiv, hepatitis-b, hepatitis-c, or hepatitis a infection
Descripción

hiv, hepatitis a, b, c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
infection requiring antibiotics or hospitalization within the last 2 weeks
Descripción

infections, antibiotics, hospitalization

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0003232
UMLS CUI [1,3]
C0019993
major surgery within the last 4 weeks
Descripción

major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
diagnosis with poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
Descripción

poems syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085404
history of other cancers within the past 5 years
Descripción

other cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
pregnant or breast-feeding women
Descripción

pregnancy, breast feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Myeloma NCT00315757

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
refractory multiple myeloma
Item
diagnosed with multiple myeloma that is refractory or has relapsed after treatment
boolean
C0026764 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
m-protein serum, urine
Item
measurable serum and/or urine m-protein
boolean
C0700271 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
multiple myeloma failed therapies
Item
failed 1 or 2 prior therapies for multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C023117 (UMLS CUI [1,3])
age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
multiple myeloma prior therapies
Item
received more than 2 prior therapies for multiple myeloma.
boolean
C0026764 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
previous cancer therapy
Item
previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks
boolean
C1514463 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
monoclonal antibodies
Item
received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)
boolean
C0003250 (UMLS CUI [1])
multiple myeloma investigational agent
Item
received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks
boolean
C0026764 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
autologous stem cell transplant
Item
subjects who received a stem cell transplant using cells from themselves in the past 16 weeks
boolean
C1831743 (UMLS CUI [1])
allogeneic stem cell transplant
Item
subjects who received a stem cell transplant using cells from another individual
boolean
C2242529 (UMLS CUI [1])
bortezomib, mapatumumab
Item
previously treated with bortezomib or mapatumumab
boolean
C1176309 (UMLS CUI [1])
C1665688 (UMLS CUI [2])
hiv, hepatitis a, b, c
Item
known hiv, hepatitis-b, hepatitis-c, or hepatitis a infection
boolean
C0019682 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
infections, antibiotics, hospitalization
Item
infection requiring antibiotics or hospitalization within the last 2 weeks
boolean
C0009450 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
major surgery
Item
major surgery within the last 4 weeks
boolean
C0679637 (UMLS CUI [1])
poems syndrome
Item
diagnosis with poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
boolean
C0085404 (UMLS CUI [1])
other cancer
Item
history of other cancers within the past 5 years
boolean
C0006826 (UMLS CUI [1])
pregnancy, breast feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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