ID

13058

Description

An Open Protocol for the Compassionate Use of Thalidomide; ODM derived from: https://clinicaltrials.gov/show/NCT00081757

Link

https://clinicaltrials.gov/show/NCT00081757

Keywords

Versions (1)
  1. 1/13/16 1/13/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 13, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT00081757

English

Eligibility Multiple Myeloma NCT00081757

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have a confirmed malignancy which can be classified as locally advanced or distant metastatic disease and must have either 1) failed on standard therapy or 2) have disease for which in the opinion of the investigator, no adequate standard +therapy exists.
Description

multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
patients must be 18 years of age or older. women of childbearing potential must have a negative pregnancy test and fertile women and men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
Description

age, pregnany, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0700589
patients must sign an informed consent to participate in this study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
swog performance status 0-3, unless related to cancer pain.
Description

swog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy.
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
Description

post-menopausal or hysterectomy

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0020699
patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine < or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or =1.5 mg/dl and transaminases < or =4 x uln.
Description

hematologic, renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0002594
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not be eligible for any uams participating clinical trial of higher priority.
Description

patients must not be eligible for any uams participating clinical trial of higher priority.

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Multiple Myeloma NCT00081757

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma
Item
all patients must have a confirmed malignancy which can be classified as locally advanced or distant metastatic disease and must have either 1) failed on standard therapy or 2) have disease for which in the opinion of the investigator, no adequate standard +therapy exists.
boolean
C0026764 (UMLS CUI [1])
age, pregnany, contraception
Item
patients must be 18 years of age or older. women of childbearing potential must have a negative pregnancy test and fertile women and men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
informed consent
Item
patients must sign an informed consent to participate in this study.
boolean
C0021430 (UMLS CUI [1])
swog performance status
Item
swog performance status 0-3, unless related to cancer pain.
boolean
C1518965 (UMLS CUI [1])
pregnancy test
Item
before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy.
boolean
C0032961 (UMLS CUI [1])
post-menopausal or hysterectomy
Item
pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
boolean
C0232970 (UMLS CUI [1])
C0020699 (UMLS CUI [2])
hematologic, renal and hepatic function
Item
patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine < or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or =1.5 mg/dl and transaminases < or =4 x uln.
boolean
C0023508 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0002594 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
patients must not be eligible for any uams participating clinical trial of higher priority.
Item
patients must not be eligible for any uams participating clinical trial of higher priority.
boolean
C2348568 (UMLS CUI [1])
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