ID

16590

Beschrijving

Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00193544

Link

https://clinicaltrials.gov/show/NCT00193544

Trefwoorden

  1. 25-07-16 25-07-16 -
Geüploaded op

25 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00193544

Eligibility Multiple Myeloma NCT00193544

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in this study, you must meet the following criteria:
Beschrijving

inclusion criteria

Datatype

boolean

confirmed diagnosis of multiple myeloma
Beschrijving

multiple myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
received at least one previous chemotherapy regimen at most 3 previous
Beschrijving

prior chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
Beschrijving

thalidomide chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0039736
age at least 18 years years
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
able to perform activities of daily living with minimal assistance
Beschrijving

living with minimal assistance

Datatype

boolean

Alias
UMLS CUI [1]
C0021189
life expectancy more than 3 months
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow, liver and kidney function
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
must give written informed consent in order to participate.
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot participate in this study if any of the following apply to you:
Beschrijving

exclusion criteria

Datatype

boolean

women pregnant or lactating.
Beschrijving

pregnant or lactating

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
pre-existing moderate neuropathy
Beschrijving

pre-existing moderate neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0442874
patients with significant underlying cardiac dysfunction
Beschrijving

significant cardiac dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C3277906
uncontrolled hypercalcemia
Beschrijving

uncontrolled hypercalcemia

Datatype

boolean

Alias
UMLS CUI [1]
C0020437
active serious infections not controlled by antibiotics
Beschrijving

untreated communicable disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332155
history of grand mal seizures (other than infantile febrile seizures)
Beschrijving

history of grand mal seizures

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
receiving other medications that prolong the qt interval.
Beschrijving

medications that prolong the qt interval.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0429028
UMLS CUI [1,2]
C0013227
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Beschrijving

ID.18

Datatype

boolean

Similar models

Eligibility Multiple Myeloma NCT00193544

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
inclusion criteria
Item
to be included in this study, you must meet the following criteria:
boolean
multiple myeloma
Item
confirmed diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
prior chemotherapy
Item
received at least one previous chemotherapy regimen at most 3 previous
boolean
C1514457 (UMLS CUI [1])
thalidomide chemotherapy
Item
thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
boolean
C0392920 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
age
Item
age at least 18 years years
boolean
C0001779 (UMLS CUI [1])
living with minimal assistance
Item
able to perform activities of daily living with minimal assistance
boolean
C0021189 (UMLS CUI [1])
life expectancy
Item
life expectancy more than 3 months
boolean
C0023671 (UMLS CUI [1])
comorbidity
Item
adequate bone marrow, liver and kidney function
boolean
C0009488 (UMLS CUI [1])
written informed consent
Item
must give written informed consent in order to participate.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exclusion criteria
Item
you cannot participate in this study if any of the following apply to you:
boolean
pregnant or lactating
Item
women pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
pre-existing moderate neuropathy
Item
pre-existing moderate neuropathy
boolean
C0442874 (UMLS CUI [1])
significant cardiac dysfunction
Item
patients with significant underlying cardiac dysfunction
boolean
C3277906 (UMLS CUI [1])
uncontrolled hypercalcemia
Item
uncontrolled hypercalcemia
boolean
C0020437 (UMLS CUI [1])
untreated communicable disease
Item
active serious infections not controlled by antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
history of grand mal seizures
Item
history of grand mal seizures (other than infantile febrile seizures)
boolean
C0014544 (UMLS CUI [1])
medications that prolong the qt interval.
Item
receiving other medications that prolong the qt interval.
boolean
C0429028 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
ID.18
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean

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