ID

44795

Beschreibung

A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01464112

Link

https://clinicaltrials.gov/show/NCT01464112

Stichworte

Versionen (1)
  1. 30.11.21 30.11.21 - Tabea Kampen
Rechteinhaber

Janssen Research & Development, LLC

Hochgeladen am

30. November 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01464112

Deutsch Englisch

Eligibility Multiple Myeloma NCT01464112

1 Formulare  
Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI [1]
C1512693
eastern cooperative oncology group (ecog) performance status score 0-2
Beschreibung

ECOG

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
measurable or secretory multiple myeloma
Beschreibung

Diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1513041
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C1327616
relapse or progression of myeloma following prior systemic antineoplastic therapy
Beschreibung

Course of the disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C2346834
UMLS CUI [1,4]
C0205373
UMLS CUI [2,1]
C0178874
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C2346834
UMLS CUI [2,4]
C0205373
pretreatment clinical laboratory values meeting protocol-specified criteria
Beschreibung

Lab values

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C0022885
left ventricular ejection fraction rate within normal limits
Beschreibung

Kardiac function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI [1]
C0680251
peripheral neuropathy or neuralgia >=2, according to national cancer institute common terminology criteria for adverse events (nci-ctcae) version 4.0
Beschreibung

PNS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0027796
UMLS CUI [2,2]
C1516728
diagnosis of primary amyloidosis, plasma cell leukemia, or other similar conditions
Beschreibung

Related diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0268381
UMLS CUI [2]
C0268381
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0026764
UMLS CUI [3,3]
C2348205
diagnosis of waldenstrom macroglobulinemia with protocol-specified immunoglobulin levels
Beschreibung

Makroglobulinemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024419
UMLS CUI [1,2]
C0202084
prior histone-deacetylase inhibitor therapy - more than 3 prior lines of therapy
Beschreibung

Histone-deacetylase inhibitor therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1512474
cardiac risk factors: unstable angina or myocardial infarction within the preceding 12 months, congestive heart failure (new york heart association class ii-iv), known presence of dilated, hypertrophic, or restrictive cardiomyopathy
Beschreibung

Cardiac risk factors

Datentyp

boolean

Alias
UMLS CUI [1]
C2024776
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0007194
UMLS CUI [5,2]
C0007196
UMLS CUI [5,3]
C0007193
any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the patient at an unacceptably increased risk with study drug
Beschreibung

Cardiac risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C1704258
history of any of the following: sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, atrial fibrillation, cardiac arrest, mobitz ii second degree heart block, or third degree heart block - qtc at screening > 450 ms in males / > 470 ms in females
Beschreibung

ECG abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0750197
UMLS CUI [3]
C0042510
UMLS CUI [4]
C0040479
UMLS CUI [5]
C0004238
UMLS CUI [6]
C0018790
UMLS CUI [7]
C0155700
UMLS CUI [8]
C0151517
UMLS CUI [9,1]
C1560305
UMLS CUI [9,2]
C0220908
family history of short qt syndrome, long qt syndrome
Beschreibung

Family history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0023976
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C2348199
obligate use of a cardiac pacemaker - use of medications that may cause torsades de pointes
Beschreibung

Cardiac comorbidities

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0040479
UMLS CUI [2,3]
C0458082
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT01464112

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status score 0-2
boolean
C1520224 (UMLS CUI [1])
Diagnosis
Item
measurable or secretory multiple myeloma
boolean
C0026764 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C1327616 (UMLS CUI [2,2])
Course of the disease
Item
relapse or progression of myeloma following prior systemic antineoplastic therapy
boolean
C0277556 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C2346834 (UMLS CUI [1,3])
C0205373 (UMLS CUI [1,4])
C0178874 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C2346834 (UMLS CUI [2,3])
C0205373 (UMLS CUI [2,4])
Lab values
Item
pretreatment clinical laboratory values meeting protocol-specified criteria
boolean
C3539076 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Kardiac function
Item
left ventricular ejection fraction rate within normal limits
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1])
PNS
Item
peripheral neuropathy or neuralgia >=2, according to national cancer institute common terminology criteria for adverse events (nci-ctcae) version 4.0
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0027796 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Related diseases
Item
diagnosis of primary amyloidosis, plasma cell leukemia, or other similar conditions
boolean
C0268381 (UMLS CUI [1])
C0268381 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
Makroglobulinemia
Item
diagnosis of waldenstrom macroglobulinemia with protocol-specified immunoglobulin levels
boolean
C0024419 (UMLS CUI [1,1])
C0202084 (UMLS CUI [1,2])
Histone-deacetylase inhibitor therapy
Item
prior histone-deacetylase inhibitor therapy - more than 3 prior lines of therapy
boolean
C1514463 (UMLS CUI [1,1])
C1512474 (UMLS CUI [1,2])
Cardiac risk factors
Item
cardiac risk factors: unstable angina or myocardial infarction within the preceding 12 months, congestive heart failure (new york heart association class ii-iv), known presence of dilated, hypertrophic, or restrictive cardiomyopathy
boolean
C2024776 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0007194 (UMLS CUI [5,1])
C0007196 (UMLS CUI [5,2])
C0007193 (UMLS CUI [5,3])
Cardiac risk
Item
any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the patient at an unacceptably increased risk with study drug
boolean
C0018787 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
ECG abnormalities
Item
history of any of the following: sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, atrial fibrillation, cardiac arrest, mobitz ii second degree heart block, or third degree heart block - qtc at screening > 450 ms in males / > 470 ms in females
boolean
C0522055 (UMLS CUI [1])
C0750197 (UMLS CUI [2])
C0042510 (UMLS CUI [3])
C0040479 (UMLS CUI [4])
C0004238 (UMLS CUI [5])
C0018790 (UMLS CUI [6])
C0155700 (UMLS CUI [7])
C0151517 (UMLS CUI [8])
C1560305 (UMLS CUI [9,1])
C0220908 (UMLS CUI [9,2])
Family history
Item
family history of short qt syndrome, long qt syndrome
boolean
C0241889 (UMLS CUI [1,1])
C0023976 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C2348199 (UMLS CUI [2,2])
Cardiac comorbidities
Item
obligate use of a cardiac pacemaker - use of medications that may cause torsades de pointes
boolean
C0030163 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0040479 (UMLS CUI [2,2])
C0458082 (UMLS CUI [2,3])
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