ID

15504

Beschreibung

An Open-Label, Phase 1b Study of ACP-196 With and Without Dexamethasone in Subjects With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02211014

Link

https://clinicaltrials.gov/show/NCT02211014

Stichworte

Versionen (1)
  1. 01.06.16 01.06.16 -
Hochgeladen am

1. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma (MM) NCT02211014

Englisch

Eligibility Multiple Myeloma (MM) NCT02211014

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ≥ 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
a confirmed diagnosis of mm, which has relapsed after, or been refractory to ≥ 1 prior therapy for mm, and is progressing at the time of study entry.
Beschreibung

Multiple Myeloma | Recurrent disease | Refractory Prior Therapy | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C1514463
UMLS CUI [4]
C0242656
eastern cooperative oncology group (ecog) performance status of ≤ 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Beschreibung

Sexually active | Females & males of reproductive potential | Agreement Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0241028
UMLS CUI [2]
C4034483
UMLS CUI [3,1]
C0680240
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk
Beschreibung

Life threatening illness | Medical condition | Organ dysfunction | Patient safety At risk | Interferes with absorption ACP-196 | Interferes with metabolic aspects ACP-196 | Risk research results

Datentyp

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C1699700
UMLS CUI [3]
C0349410
UMLS CUI [4,1]
C1113679
UMLS CUI [4,2]
C1444641
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0678745
UMLS CUI [5,3]
C3827171
UMLS CUI [6,1]
C0521102
UMLS CUI [6,2]
C0025520
UMLS CUI [6,3]
C3827171
UMLS CUI [7,1]
C0035647
UMLS CUI [7,2]
C0683954
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification
Beschreibung

Cardiovascular Diseases | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction | New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0741212
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
UMLS CUI [6]
C1275491
malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
Beschreibung

Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastric Bypass | Excision Stomach | Small intestine excision | Inflammatory Bowel Diseases Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
UMLS CUI [3]
C0017125
UMLS CUI [4,1]
C0728940
UMLS CUI [4,2]
C0038351
UMLS CUI [5]
C0192601
UMLS CUI [6,1]
C0021390
UMLS CUI [6,2]
C0231220
UMLS CUI [7]
C1328480
UMLS CUI [8,1]
C0021843
UMLS CUI [8,2]
C0205197
breast feeding or pregnant
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Multiple Myeloma (MM) NCT02211014

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma | Recurrent disease | Refractory Prior Therapy | Disease Progression
Item
a confirmed diagnosis of mm, which has relapsed after, or been refractory to ≥ 1 prior therapy for mm, and is progressing at the time of study entry.
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0205269 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C0242656 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Sexually active | Females & males of reproductive potential | Agreement Contraceptive methods
Item
agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
boolean
C0241028 (UMLS CUI [1])
C4034483 (UMLS CUI [2])
C0680240 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Life threatening illness | Medical condition | Organ dysfunction | Patient safety At risk | Interferes with absorption ACP-196 | Interferes with metabolic aspects ACP-196 | Risk research results
Item
a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk
boolean
C3846017 (UMLS CUI [1])
C1699700 (UMLS CUI [2])
C0349410 (UMLS CUI [3])
C1113679 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0521102 (UMLS CUI [5,1])
C0678745 (UMLS CUI [5,2])
C3827171 (UMLS CUI [5,3])
C0521102 (UMLS CUI [6,1])
C0025520 (UMLS CUI [6,2])
C3827171 (UMLS CUI [6,3])
C0035647 (UMLS CUI [7,1])
C0683954 (UMLS CUI [7,2])
Cardiovascular Diseases | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure | Myocardial Infarction | New York Heart Association Classification
Item
significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification
boolean
C0007222 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0741212 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C1275491 (UMLS CUI [6])
Malabsorption Syndrome | Disease Affecting gastrointestinal function | Gastric Bypass | Excision Stomach | Small intestine excision | Inflammatory Bowel Diseases Symptomatic | Partial bowel obstruction | Intestinal Obstruction Complete
Item
malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C0017125 (UMLS CUI [3])
C0728940 (UMLS CUI [4,1])
C0038351 (UMLS CUI [4,2])
C0192601 (UMLS CUI [5])
C0021390 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C1328480 (UMLS CUI [7])
C0021843 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
Pregnancy | Breast Feeding
Item
breast feeding or pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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