ID

21948

Beskrivning

Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00412919

Länk

https://clinicaltrials.gov/show/NCT00412919

Nyckelord

Versioner (1)
  1. 2017-05-09 2017-05-09 -
Uppladdad den

9 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00412919

Engelsk

Eligibility Multiple Myeloma NCT00412919

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of mm as per imwg criteria
Beskrivning

Multiple Myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
age greater than 17 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have received at least 2 but no more than 4 prior lines of therapy
Beskrivning

Therapeutic procedure Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1265611
have failed to respond to the most recently administered anti-mm therapy or have demonstrably progressive disease as defined by accepted standard criteria
Beskrivning

Multiple Myeloma Absent response to treatment | Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0438286
UMLS CUI [2]
C1335499
have a life expectancy of at least 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status < 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
at registration haematological values within the following limits:
Beskrivning

Results Hematologic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205488
1. absolute neutrophil count (anc) > 1.0 x 109/l
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count > 50 x 109/l unsupported
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
at registration biochemical values within the following limits
Beskrivning

Results Biochemical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205474
1. bilirubin < 1.5 x upper limit of normal (uln) and transaminases < 2 x uln unless considered secondary to hepatic myelomatous infiltration
Beskrivning

Serum total bilirubin measurement | Transaminases | Serum total bilirubin measurement Secondary to Infiltration Myeloma Liver | Transaminases Secondary to Infiltration Myeloma Liver

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0002594
UMLS CUI [3,1]
C1278039
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0332448
UMLS CUI [3,4]
C0026764
UMLS CUI [3,5]
C0023884
UMLS CUI [4,1]
C0002594
UMLS CUI [4,2]
C0175668
UMLS CUI [4,3]
C0332448
UMLS CUI [4,4]
C0026764
UMLS CUI [4,5]
C0023884
2. serum creatinine < 0.19mmol/l
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
must agree to use adequate contraceptive measures if indicated. specifically, women of childbearing potential (wocbp) may participate provided they meet the following conditions:
Beskrivning

Indication Contraceptive methods | Childbearing Potential Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C1550543
1. agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the study
Beskrivning

Childbearing Potential Contraceptive methods Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
2. have a negative serum pregnancy test within 24 hours of commencing on study medication
Beskrivning

Childbearing Potential Serum pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
3. male participants with female partners that are wocbp must agree to use 2 effective contraceptive methods throughout the study and for 30 days following the study
Beskrivning

Gender Contraceptive methods Quantity | Partner Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C3831118
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with monoclonal gammopathy of undetermined significance (mgus) or indolent/smouldering mm
Beskrivning

Monoclonal Gammopathy of Undetermined Significance | Indolent multiple myeloma | Smoldering myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0026470
UMLS CUI [2]
C2049069
UMLS CUI [3]
C1531608
known or suspected hypersensitivity to aza or mannitol
Beskrivning

Hypersensitivity Azathioprine | Mannitol allergy | Hypersensitivity Azathioprine Suspected | Mannitol allergy Suspected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004482
UMLS CUI [2]
C0571922
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0004482
UMLS CUI [3,3]
C0750491
UMLS CUI [4,1]
C0571922
UMLS CUI [4,2]
C0750491
patients whose general condition makes them unsuitable for intensive treatment e.g. significant cardiac or pulmonary disease
Beskrivning

General condition of patient Therapeutic procedure With intensity Inappropriate | Heart Disease | Lung disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424449
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0522510
UMLS CUI [1,4]
C1548788
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0024115
active infections or other illnesses that precludes chemotherapy administration or patient compliance
Beskrivning

Communicable Diseases Exclude Chemotherapy | Illness Excludes Chemotherapy | Communicable Diseases Exclude Compliance behavior | Illness Excludes Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1321605
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C1321605
active viral infection with known human immunodeficiency virus (hiv) or viral hepatitis type b or c
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Multiple Myeloma NCT00412919

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
diagnosis of mm as per imwg criteria
boolean
C0026764 (UMLS CUI [1])
Age
Item
age greater than 17 years
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Quantity
Item
have received at least 2 but no more than 4 prior lines of therapy
boolean
C0087111 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Multiple Myeloma Absent response to treatment | Progressive Disease
Item
have failed to respond to the most recently administered anti-mm therapy or have demonstrably progressive disease as defined by accepted standard criteria
boolean
C0026764 (UMLS CUI [1,1])
C0438286 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status < 3
boolean
C1520224 (UMLS CUI [1])
Results Hematologic
Item
at registration haematological values within the following limits:
boolean
C1254595 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) > 1.0 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelet count > 50 x 109/l unsupported
boolean
C0032181 (UMLS CUI [1])
Results Biochemical
Item
at registration biochemical values within the following limits
boolean
C1254595 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
Serum total bilirubin measurement | Transaminases | Serum total bilirubin measurement Secondary to Infiltration Myeloma Liver | Transaminases Secondary to Infiltration Myeloma Liver
Item
1. bilirubin < 1.5 x upper limit of normal (uln) and transaminases < 2 x uln unless considered secondary to hepatic myelomatous infiltration
boolean
C1278039 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
C1278039 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0332448 (UMLS CUI [3,3])
C0026764 (UMLS CUI [3,4])
C0023884 (UMLS CUI [3,5])
C0002594 (UMLS CUI [4,1])
C0175668 (UMLS CUI [4,2])
C0332448 (UMLS CUI [4,3])
C0026764 (UMLS CUI [4,4])
C0023884 (UMLS CUI [4,5])
Creatinine measurement, serum
Item
2. serum creatinine < 0.19mmol/l
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Indication Contraceptive methods | Childbearing Potential Criteria Fulfill
Item
must agree to use adequate contraceptive measures if indicated. specifically, women of childbearing potential (wocbp) may participate provided they meet the following conditions:
boolean
C3146298 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C1550543 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Quantity
Item
1. agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative
Item
2. have a negative serum pregnancy test within 24 hours of commencing on study medication
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Gender Contraceptive methods Quantity | Partner Childbearing Potential
Item
3. male participants with female partners that are wocbp must agree to use 2 effective contraceptive methods throughout the study and for 30 days following the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Monoclonal Gammopathy of Undetermined Significance | Indolent multiple myeloma | Smoldering myeloma
Item
patients with monoclonal gammopathy of undetermined significance (mgus) or indolent/smouldering mm
boolean
C0026470 (UMLS CUI [1])
C2049069 (UMLS CUI [2])
C1531608 (UMLS CUI [3])
Hypersensitivity Azathioprine | Mannitol allergy | Hypersensitivity Azathioprine Suspected | Mannitol allergy Suspected
Item
known or suspected hypersensitivity to aza or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0004482 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0004482 (UMLS CUI [3,2])
C0750491 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
General condition of patient Therapeutic procedure With intensity Inappropriate | Heart Disease | Lung disease
Item
patients whose general condition makes them unsuitable for intensive treatment e.g. significant cardiac or pulmonary disease
boolean
C0424449 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0018799 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
Communicable Diseases Exclude Chemotherapy | Illness Excludes Chemotherapy | Communicable Diseases Exclude Compliance behavior | Illness Excludes Compliance behavior
Item
active infections or other illnesses that precludes chemotherapy administration or patient compliance
boolean
C0009450 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0221423 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
active viral infection with known human immunodeficiency virus (hiv) or viral hepatitis type b or c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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