ID

13211

Description

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

Lien

https://clinicaltrials.gov/show/NCT00344422

Mots-clés

  1. 24/01/2016 24/01/2016 -
Téléchargé le

24 janvier 2016

DOI

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Licence

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00344422

Eligibility Multiple Myeloma NCT00344422

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
untreated multiple myeloma requiring treatment
Description

multiple myeloma

Type de données

boolean

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

doxorubicin

Type de données

boolean

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

measurable disease

Type de données

boolean

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

lvef

Type de données

boolean

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

karnofsky

Type de données

boolean

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

ID.6

Type de données

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
Description

malignancy

Type de données

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.
Description

contraception

Type de données

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

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

life expectancy

Type de données

boolean

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

pregnant or breast feeding

Type de données

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
Description

cardiac disease

Type de données

boolean

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

cardiovascular disease

Type de données

boolean

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

diabetes mellitus, systemic infection

Type de données

boolean

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

other myeloma types

Type de données

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
Description

mental disorder

Type de données

boolean

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

chemotherapy

Type de données

boolean

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

radiotherapy

Type de données

boolean

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

radiotherapy

Type de données

boolean

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

medication

Type de données

boolean

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

corticosteroid

Type de données

boolean

Alias
UMLS CUI [1]
C0001617

Similar models

Eligibility Multiple Myeloma NCT00344422

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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