ID

13211

Beskrivning

Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00344422

Länk

https://clinicaltrials.gov/show/NCT00344422

Nyckelord

  1. 2016-01-24 2016-01-24 -
Uppladdad den

24 januari 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00344422

Eligibility Multiple Myeloma NCT00344422

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
untreated multiple myeloma requiring treatment
Beskrivning

multiple myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
total cumulative dose of prior doxorubicin can not exceed 240 mg/m2
Beskrivning

doxorubicin

Datatyp

boolean

Alias
UMLS CUI [1]
C0013089
must have measurable disease
Beskrivning

measurable disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
left ventricular ejection fraction (lvef) >= 50 % determined by multiple gated acquisition scan (muga)
Beskrivning

lvef

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521317
UMLS CUI [1,2]
C0428772
karnofsky performance status of >= 60%
Beskrivning

karnofsky

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
adequate bone marrow, liver and renal function
Beskrivning

ID.6

Datatyp

boolean

disease-free from prior malignancies >= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Beskrivning

malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control.
Beskrivning

contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy of >= 3 months
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
pregnant or breast feeding
Beskrivning

pregnant or breast feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of cardiac disease, with new york heart association class ii or greater, with congestive heart failure
Beskrivning

cardiac disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months
Beskrivning

cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
uncontrolled diabetes mellitus or systemic infection
Beskrivning

diabetes mellitus, systemic infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0009450
nonsecretory myeloma, monoclonal gammopathy of unknown significance (mgus) or smoldering myeloma
Beskrivning

other myeloma types

Datatyp

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2]
C0026470
UMLS CUI [3]
C1531608
confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent
Beskrivning

mental disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
prior chemotherapy to treat multiple myeloma
Beskrivning

chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
prior radiotherapy to an area greater than 1/3 of the skeleton
Beskrivning

radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
prior local radiotherapy within 1 week of treatment
Beskrivning

radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
any investigational agent within 30 days of the first dose of treatment
Beskrivning

medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C2348568
prior single agent dexamethasone (or another corticosteroid) to treat multiple myeloma.
Beskrivning

corticosteroid

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617

Similar models

Eligibility Multiple Myeloma NCT00344422

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma
Item
untreated multiple myeloma requiring treatment
boolean
C0026764 (UMLS CUI [1])
doxorubicin
Item
total cumulative dose of prior doxorubicin can not exceed 240 mg/m2
boolean
C0013089 (UMLS CUI [1])
measurable disease
Item
must have measurable disease
boolean
C1513041 (UMLS CUI [1])
lvef
Item
left ventricular ejection fraction (lvef) >= 50 % determined by multiple gated acquisition scan (muga)
boolean
C0521317 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
karnofsky
Item
karnofsky performance status of >= 60%
boolean
C0206065 (UMLS CUI [1])
ID.6
Item
adequate bone marrow, liver and renal function
boolean
malignancy
Item
disease-free from prior malignancies >= 5 years with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
contraception
Item
female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
life expectancy
Item
life expectancy of >= 3 months
boolean
C0023671 (UMLS CUI [1])
pregnant or breast feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cardiac disease
Item
history of cardiac disease, with new york heart association class ii or greater, with congestive heart failure
boolean
C0018799 (UMLS CUI [1])
cardiovascular disease
Item
or unstable angina, uncontrolled hypertension or cardiac arrythmias or myocardial infarction within the last 6 months
boolean
C0007222 (UMLS CUI [1])
diabetes mellitus, systemic infection
Item
uncontrolled diabetes mellitus or systemic infection
boolean
C0011849 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
other myeloma types
Item
nonsecretory myeloma, monoclonal gammopathy of unknown significance (mgus) or smoldering myeloma
boolean
C0456845 (UMLS CUI [1])
C0026470 (UMLS CUI [2])
C1531608 (UMLS CUI [3])
mental disorder
Item
confusion, disorientation, or history of psychiatric illness which may impair patient's ability to give informed consent
boolean
C0004936 (UMLS CUI [1])
chemotherapy
Item
prior chemotherapy to treat multiple myeloma
boolean
C0392920 (UMLS CUI [1])
radiotherapy
Item
prior radiotherapy to an area greater than 1/3 of the skeleton
boolean
C1522449 (UMLS CUI [1])
radiotherapy
Item
prior local radiotherapy within 1 week of treatment
boolean
C1522449 (UMLS CUI [1])
medication
Item
any investigational agent within 30 days of the first dose of treatment
boolean
C0013227 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
corticosteroid
Item
prior single agent dexamethasone (or another corticosteroid) to treat multiple myeloma.
boolean
C0001617 (UMLS CUI [1])

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