ID

37005

Beskrivning

ATRA, Celecoxib, and Itraconazole as Maintenance; ODM derived from: https://clinicaltrials.gov/show/NCT02401295

Länk

https://clinicaltrials.gov/show/NCT02401295

Nyckelord

Versioner (1)
  1. 2019-06-29 2019-06-29 -
Rättsinnehavare

See clinicaltrials.gov

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29 juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Relapsed Multiple Myeloma NCT02401295

Engelsk

Eligibility Relapsed Multiple Myeloma NCT02401295

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of relapsed multiple myeloma
Beskrivning

Recurrent multiple myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C1370446
recent salvage transplant (≤ 6 months but ≥ 45 days post-transplant prior to study enrollment) for relapse
Beskrivning

Salvage Transplantation Relapse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442967
UMLS CUI [1,2]
C0040732
UMLS CUI [1,3]
C0035020
18-75 years of age at the time of study entry
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
platelet count ≥70k/mm3 un-transfused
Beskrivning

Platelet Count measurement | Blood Transfusion Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0005841
UMLS CUI [2,2]
C0332197
resolution of all transplant-related toxicity to ≤ grade 2 per ctcae v.4
Beskrivning

Toxicity Transplantation Related | Resolution CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0040732
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C1516728
left ventricular ejection fraction as measured by echo or muga should be ≥ 40%
Beskrivning

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
creatinine of ≤ 2 mg/dl and a calculated gfr of >50ml/min/1.73m2
Beskrivning

Creatinine measurement, serum | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C3811844
a total bilirubin, alt, ast, and alkaline phosphatase of ≤ 2 uln
Beskrivning

Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201850
performance status of 0-2 based on the ecog criteria. patients with performance status 3 or 4, based solely on bone pain, are also eligible, provided that there is a source document to verify this
Beskrivning

ECOG performance status | ECOG performance status Bone pain

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2,1]
C1520224
UMLS CUI [2,2]
C0151825
prospective study participants must be informed of the investigational nature of the study and must have signed an irb-approved informed consent form in accordance with institutional and federal guidelines
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior allogeneic transplant
Beskrivning

Allogeneic Transplantation Previous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040739
UMLS CUI [1,2]
C0205156
greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening
Beskrivning

Motor neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0235025
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0151313
UMLS CUI [2,2]
C1516728
uncontrolled diabetes
Beskrivning

Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
recent (< 6 months) myocardial infarction, unstable angina, cabg or stent placement in the last 2 years, difficult-to-control congestive heart failure, uncontrolled hypertension (systolic blood pressure > 160 mm or a diastolic bp > 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult- to-control cardiac arrhythmias
Beskrivning

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Placement of stent | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Cardiac Arrhythmia CONTROL DIFFICULT

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0522776
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0742800
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0871470
UMLS CUI [8]
C0428883
UMLS CUI [9]
C0003364
UMLS CUI [10,1]
C0003811
UMLS CUI [10,2]
C0742800
evidence of qt prolongation and/or torsades de pointes (tdp) on ekg.
Beskrivning

Prolonged QT interval ECG | EKG torsades de pointes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151878
UMLS CUI [1,2]
C0013798
UMLS CUI [2]
C1960156
any co-morbid condition that poses a greater threat to the patient's life expectancy than the recurrent myeloma
Beskrivning

Comorbidity At risk Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0023671
no concurrent malignancy with a life expectancy of less than two years, or one that requires ongoing chemotherapeutic intervention at screening
Beskrivning

Malignant Neoplasm Life Expectancy | Malignant Neoplasm Requirement Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0023671
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0392920
presence of an infection that requires intravenous antibiotics
Beskrivning

Communicable Disease | Requirement Antibiotics Intravenous

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003232
UMLS CUI [2,3]
C1522726
pregnant or nursing females. any patient of reproductive potential may not participate unless he/she has agreed to use an effective contraceptive method as covered during the informed consent process
Beskrivning

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
known history of an hiv seropositive test
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Relapsed Multiple Myeloma NCT02401295

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent multiple myeloma
Item
diagnosis of relapsed multiple myeloma
boolean
C1370446 (UMLS CUI [1])
Salvage Transplantation Relapse
Item
recent salvage transplant (≤ 6 months but ≥ 45 days post-transplant prior to study enrollment) for relapse
boolean
C0442967 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
Age
Item
18-75 years of age at the time of study entry
boolean
C0001779 (UMLS CUI [1])
Platelet Count measurement | Blood Transfusion Absent
Item
platelet count ≥70k/mm3 un-transfused
boolean
C0032181 (UMLS CUI [1])
C0005841 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Toxicity Transplantation Related | Resolution CTCAE Grades
Item
resolution of all transplant-related toxicity to ≤ grade 2 per ctcae v.4
boolean
C0600688 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1514893 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA
Item
left ventricular ejection fraction as measured by echo or muga should be ≥ 40%
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Creatinine measurement, serum | Estimated Glomerular Filtration Rate
Item
creatinine of ≤ 2 mg/dl and a calculated gfr of >50ml/min/1.73m2
boolean
C0201976 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
a total bilirubin, alt, ast, and alkaline phosphatase of ≤ 2 uln
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
ECOG performance status | ECOG performance status Bone pain
Item
performance status of 0-2 based on the ecog criteria. patients with performance status 3 or 4, based solely on bone pain, are also eligible, provided that there is a source document to verify this
boolean
C1520224 (UMLS CUI [1])
C1520224 (UMLS CUI [2,1])
C0151825 (UMLS CUI [2,2])
Informed Consent
Item
prospective study participants must be informed of the investigational nature of the study and must have signed an irb-approved informed consent form in accordance with institutional and federal guidelines
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allogeneic Transplantation Previous
Item
prior allogeneic transplant
boolean
C0040739 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Motor neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades
Item
greater than grade 2 motor neuropathy or greater than grade 3 sensory neuropathy at screening
boolean
C0235025 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0151313 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Placement of stent | Congestive heart failure CONTROL DIFFICULT | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents | Cardiac Arrhythmia CONTROL DIFFICULT
Item
recent (< 6 months) myocardial infarction, unstable angina, cabg or stent placement in the last 2 years, difficult-to-control congestive heart failure, uncontrolled hypertension (systolic blood pressure > 160 mm or a diastolic bp > 110 mm under normal conditions and while on appropriate anti-hypertensive medications), or difficult- to-control cardiac arrhythmias
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0522776 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0742800 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
C0003364 (UMLS CUI [9])
C0003811 (UMLS CUI [10,1])
C0742800 (UMLS CUI [10,2])
Prolonged QT interval ECG | EKG torsades de pointes
Item
evidence of qt prolongation and/or torsades de pointes (tdp) on ekg.
boolean
C0151878 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C1960156 (UMLS CUI [2])
Comorbidity At risk Life Expectancy
Item
any co-morbid condition that poses a greater threat to the patient's life expectancy than the recurrent myeloma
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Malignant Neoplasm Life Expectancy | Malignant Neoplasm Requirement Chemotherapy
Item
no concurrent malignancy with a life expectancy of less than two years, or one that requires ongoing chemotherapeutic intervention at screening
boolean
C0006826 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Communicable Disease | Requirement Antibiotics Intravenous
Item
presence of an infection that requires intravenous antibiotics
boolean
C0009450 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods
Item
pregnant or nursing females. any patient of reproductive potential may not participate unless he/she has agreed to use an effective contraceptive method as covered during the informed consent process
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
HIV Seropositivity
Item
known history of an hiv seropositive test
boolean
C0019699 (UMLS CUI [1])
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