ID

21903

Beschreibung

Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00388999

Link

https://clinicaltrials.gov/show/NCT00388999

Stichworte

Versionen (1)
  1. 08.05.17 08.05.17 -
Hochgeladen am

8. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00388999

Englisch

Eligibility Multiple Myeloma NCT00388999

1 Formulare  
Criteria
Beschreibung

Criteria

capable of understanding the protocol requirements and risks and providing written informed consent.
Beschreibung

Comprehension Study Protocol | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
histologically or cytologically confirmed diagnosis of multiple myeloma.
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
mannose-binding lectin level <300 ng/ml.
Beschreibung

Mannose-Binding Lectins Level

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0065693
UMLS CUI [1,2]
C0441889
age ≥18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
score of 0 to 2 on the zubrod performance status scale.
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous hsct for the treatment of multiple myeloma.
Beschreibung

HIGH DOSE CHEMOTHEARPY Melphalan Based | Transplantation of autologous hematopoietic stem cell | Therapeutic procedure Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149710
UMLS CUI [1,2]
C0025241
UMLS CUI [1,3]
C1705938
UMLS CUI [2]
C1831743
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0026764
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent serious medical illness that could potentially interfere with protocol compliance.
Beschreibung

Comorbidity Serious Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
concurrent or previous malignancy associated with a poor prognosis.
Beschreibung

Malignant Neoplasm Associated with Prognosis bad

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0278252
known chronic infectious disease, such as acquired immunodeficiency syndrome (aids) or hepatitis (for hepatitis and human immunodeficiency virus [hiv] will not be performed).
Beschreibung

Chronic infectious disease | Acquired Immunodeficiency Syndrome | Hepatitis | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0001175
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0019693
positive screening pregnancy test or is breast-feeding.
Beschreibung

Pregnancy test positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0006147
female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
Beschreibung

Females & males of reproductive potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
known or clinically suspected active brain metastases.
Beschreibung

Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0750491
current participation in another clinical study with an investigational agent and/or use of an investigational drug.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00388999

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Comprehension Study Protocol | Informed Consent
Item
capable of understanding the protocol requirements and risks and providing written informed consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Multiple Myeloma
Item
histologically or cytologically confirmed diagnosis of multiple myeloma.
boolean
C0026764 (UMLS CUI [1])
Mannose-Binding Lectins Level
Item
mannose-binding lectin level <300 ng/ml.
boolean
C0065693 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
Age
Item
age ≥18 years old.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
score of 0 to 2 on the zubrod performance status scale.
boolean
C3714786 (UMLS CUI [1])
HIGH DOSE CHEMOTHEARPY Melphalan Based | Transplantation of autologous hematopoietic stem cell | Therapeutic procedure Multiple Myeloma
Item
patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous hsct for the treatment of multiple myeloma.
boolean
C0149710 (UMLS CUI [1,1])
C0025241 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C1831743 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity Serious Interferes with Protocol Compliance
Item
concurrent serious medical illness that could potentially interfere with protocol compliance.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Malignant Neoplasm Associated with Prognosis bad
Item
concurrent or previous malignancy associated with a poor prognosis.
boolean
C0006826 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0278252 (UMLS CUI [1,3])
Chronic infectious disease | Acquired Immunodeficiency Syndrome | Hepatitis | HIV Infection
Item
known chronic infectious disease, such as acquired immunodeficiency syndrome (aids) or hepatitis (for hepatitis and human immunodeficiency virus [hiv] will not be performed).
boolean
C0151317 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
Pregnancy test positive | Breast Feeding
Item
positive screening pregnancy test or is breast-feeding.
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Suspected
Item
known or clinically suspected active brain metastases.
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
current participation in another clinical study with an investigational agent and/or use of an investigational drug.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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