ID

13766

Beschrijving

Efficacy of NF-kB Inhibition for Reducing Symptoms During Maintenance Therapy in Multiple Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01269203

Link

https://clinicaltrials.gov/show/NCT01269203

Trefwoorden

Versies (1)
  1. 05-03-16 05-03-16 -
Geüploaded op

5 maart 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01269203

Engels

Eligibility Multiple Myeloma NCT01269203

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. must have a histologically confirmed diagnosis of multiple myeloma.
Beschrijving

multiple myeloma; histology

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0019638
2. must be >/= 18 years of age.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. must have a performance status (ecog ps) of 0-2.
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
4. must be qualified and have signed consent to receive lenalidomide for maintenance therapy for mm.
Beschrijving

informed consent; lenalidomide

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1144149
5. must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
6. must also agree to refrain from use of self prescribed curcumin during the course of the study.
Beschrijving

curcumin self prescribed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0010467
UMLS CUI [1,2]
C0599401
7. must have negative pregnancy test before signing consent for mm therapy.
Beschrijving

pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. unable to understand the symptom assessment or not willing to participate in the study.
Beschrijving

symptom assessment

Datatype

boolean

Alias
UMLS CUI [1]
C3494437
2. treatment for other carcinomas within the last 5 years, except for cured non-melanoma skin and treated in-situ cervical cancer.
Beschrijving

carcinoma; in-situ cervical cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0007097
UMLS CUI [2]
C0742130
3. uncontrolled intercurrent illness including, but not limited to, ongoing or requiring iv antibiotics, cardiac disease (nyha class iii or iv heart failure), unstable angina pectoris, unstable cardiac arrhythmia or tachycardia, or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
Beschrijving

Compliance behavior Limited Comorbidity; antibiotics; cardiac disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C0003232
UMLS CUI [3]
C0018799
4. concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency.
Beschrijving

concurrent medication Coumadin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0699129
5. concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as maalox.
Beschrijving

concurrent medication; cimetidine; allopurinol; aluminium hydroxide; magnesium hydroxide; antacids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0013227
UMLS CUI [2]
C0008783
UMLS CUI [3]
C0002144
UMLS CUI [4]
C0002371
UMLS CUI [5]
C0024476
UMLS CUI [6]
C0003138
6. sorivudine and brivudine use within 4 weeks of the start of study treatment.
Beschrijving

sorivudine; brivudine

Datatype

boolean

Alias
UMLS CUI [1]
C0207628
UMLS CUI [2]
C0163272
7. gastric or duodenal ulcers, or gastric hyperacidity disorders.
Beschrijving

gastric ulcers; duodenal ulcers

Datatype

boolean

Alias
UMLS CUI [1]
C0038358
UMLS CUI [2]
C0013295
8. currently receiving anticoagulants (heparin) or antiplatelets (clopidogrel, ticlopidine, aspirin/dipyridamole)
Beschrijving

anticoagulants heparin; antiplatelets clopidogrel

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003280
UMLS CUI [1,2]
C0019134
UMLS CUI [2,1]
C0085826
UMLS CUI [2,2]
C0070166
9. inr > 1.5 (upper limit of normal = 1.5).
Beschrijving

inr

Datatype

boolean

Alias
UMLS CUI [1]
C0482691
10. history of deep vein thrombosis.
Beschrijving

medical history deep vein thrombosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0149871
11. received allogeneic transplant.
Beschrijving

allogeneic transplant

Datatype

boolean

Alias
UMLS CUI [1]
C0149615
12. allergy to turmeric, curcumin, or yellow dye.
Beschrijving

hypersensitivity turmeric; hypersensitivity curcumin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0041356
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0010467
13. bowel or bile duct obstruction.
Beschrijving

bile duct obstruction; bowel obstruction

Datatype

boolean

Alias
UMLS CUI [1]
C0008370
UMLS CUI [2]
C0021843
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Similar models

Eligibility Multiple Myeloma NCT01269203

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma; histology
Item
1. must have a histologically confirmed diagnosis of multiple myeloma.
boolean
C0026764 (UMLS CUI [1])
C0019638 (UMLS CUI [2])
age
Item
2. must be >/= 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ecog
Item
3. must have a performance status (ecog ps) of 0-2.
boolean
C1520224 (UMLS CUI [1])
informed consent; lenalidomide
Item
4. must be qualified and have signed consent to receive lenalidomide for maintenance therapy for mm.
boolean
C0021430 (UMLS CUI [1])
C1144149 (UMLS CUI [2])
informed consent
Item
5. must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary.
boolean
C0021430 (UMLS CUI [1])
curcumin self prescribed
Item
6. must also agree to refrain from use of self prescribed curcumin during the course of the study.
boolean
C0010467 (UMLS CUI [1,1])
C0599401 (UMLS CUI [1,2])
pregnancy test negative
Item
7. must have negative pregnancy test before signing consent for mm therapy.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
symptom assessment
Item
1. unable to understand the symptom assessment or not willing to participate in the study.
boolean
C3494437 (UMLS CUI [1])
carcinoma; in-situ cervical cancer
Item
2. treatment for other carcinomas within the last 5 years, except for cured non-melanoma skin and treated in-situ cervical cancer.
boolean
C0007097 (UMLS CUI [1])
C0742130 (UMLS CUI [2])
Compliance behavior Limited Comorbidity; antibiotics; cardiac disease
Item
3. uncontrolled intercurrent illness including, but not limited to, ongoing or requiring iv antibiotics, cardiac disease (nyha class iii or iv heart failure), unstable angina pectoris, unstable cardiac arrhythmia or tachycardia, or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0003232 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
concurrent medication Coumadin
Item
4. concurrent use of coumadin other than low dose (1 mg) coumadin used for line patency.
boolean
C0205420 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0699129 (UMLS CUI [1,3])
concurrent medication; cimetidine; allopurinol; aluminium hydroxide; magnesium hydroxide; antacids
Item
5. concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as maalox.
boolean
C0205420 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0008783 (UMLS CUI [2])
C0002144 (UMLS CUI [3])
C0002371 (UMLS CUI [4])
C0024476 (UMLS CUI [5])
C0003138 (UMLS CUI [6])
sorivudine; brivudine
Item
6. sorivudine and brivudine use within 4 weeks of the start of study treatment.
boolean
C0207628 (UMLS CUI [1])
C0163272 (UMLS CUI [2])
gastric ulcers; duodenal ulcers
Item
7. gastric or duodenal ulcers, or gastric hyperacidity disorders.
boolean
C0038358 (UMLS CUI [1])
C0013295 (UMLS CUI [2])
anticoagulants heparin; antiplatelets clopidogrel
Item
8. currently receiving anticoagulants (heparin) or antiplatelets (clopidogrel, ticlopidine, aspirin/dipyridamole)
boolean
C0003280 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0085826 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
inr
Item
9. inr > 1.5 (upper limit of normal = 1.5).
boolean
C0482691 (UMLS CUI [1])
medical history deep vein thrombosis
Item
10. history of deep vein thrombosis.
boolean
C0262926 (UMLS CUI [1,1])
C0149871 (UMLS CUI [1,2])
allogeneic transplant
Item
11. received allogeneic transplant.
boolean
C0149615 (UMLS CUI [1])
hypersensitivity turmeric; hypersensitivity curcumin
Item
12. allergy to turmeric, curcumin, or yellow dye.
boolean
C0020517 (UMLS CUI [1,1])
C0041356 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0010467 (UMLS CUI [2,2])
bile duct obstruction; bowel obstruction
Item
13. bowel or bile duct obstruction.
boolean
C0008370 (UMLS CUI [1])
C0021843 (UMLS CUI [2])
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