ID

25353

Description

Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00503763

Link

https://clinicaltrials.gov/show/NCT00503763

Keywords

Versions (1)
  1. 9/2/17 9/2/17 -
Uploaded on

September 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Smoldering Multiple Myeloma NCT00503763

English

Eligibility Smoldering Multiple Myeloma NCT00503763

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients fulfilling the criteria of smm. (see appendix i)
Description

Smoldering myeloma

Data type

boolean

Alias
UMLS CUI [1]
C1531608
2. patients with progressive smoldering myeloma. (see appendix ii)
Description

Smoldering myeloma Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C1531608
UMLS CUI [1,2]
C0205329
3. age 18-80 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. signed informed consent prior to patient recruitment.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients fulfilling diagnostic criteria of active mm .(see appendix i)
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
2. patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.
Description

Plasmacytoma | Non-secretory myeloma | Myeloma M Protein Very low | Light chain myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0032131
UMLS CUI [2]
C0456845
UMLS CUI [3,1]
C0026764
UMLS CUI [3,2]
C0700271
UMLS CUI [3,3]
C0442811
UMLS CUI [4]
C0456844
3. patients on statin treatment on the day of recruitment.
Description

Statins

Data type

boolean

Alias
UMLS CUI [1]
C0360714
4. patients on chemotherapy or receiving steroids.
Description

Chemotherapy | Steroids

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0038317
5. patients with any contraindication to statin treatment:
Description

Medical contraindication Statins

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0360714
known intolerance or hypersensitivity to statin.
Description

Intolerance to Statins | Statin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0360714
UMLS CUI [2]
C0571873
sgot or sgpt above 1.5 times of upper normal level (unl).
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
cpk above unl
Description

Creatine phosphokinase serum increased

Data type

boolean

Alias
UMLS CUI [1]
C0241005
concomitant treatment with macrolides and or antifungal agents (ketoconazole)
Description

Macrolides | Antifungal Agents | Ketoconazole

Data type

boolean

Alias
UMLS CUI [1]
C0282563
UMLS CUI [2]
C0003308
UMLS CUI [3]
C0022625
creatinine level above 1.5 mg%
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
any severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
Description

Disease Severe | Disease Uncontrolled | Diabetic - poor control | Chronic Kidney Diseases | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0421258
UMLS CUI [4]
C1561643
UMLS CUI [5,1]
C0009450
UMLS CUI [5,2]
C0205318
6. patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years.
Description

Second Primary Cancers | Exception Skin carcinoma | Exception Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
7. patients who have a history of alcohol or drug abuse.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
8. patients who are mentally or physically unable to comply with all aspects of the study.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
9. participation to an investigational drug trial
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Smoldering Multiple Myeloma NCT00503763

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Smoldering myeloma
Item
1. patients fulfilling the criteria of smm. (see appendix i)
boolean
C1531608 (UMLS CUI [1])
Smoldering myeloma Progressive
Item
2. patients with progressive smoldering myeloma. (see appendix ii)
boolean
C1531608 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Age
Item
3. age 18-80 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
4. signed informed consent prior to patient recruitment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Multiple Myeloma
Item
1. patients fulfilling diagnostic criteria of active mm .(see appendix i)
boolean
C0026764 (UMLS CUI [1])
Plasmacytoma | Non-secretory myeloma | Myeloma M Protein Very low | Light chain myeloma
Item
2. patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.
boolean
C0032131 (UMLS CUI [1])
C0456845 (UMLS CUI [2])
C0026764 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0442811 (UMLS CUI [3,3])
C0456844 (UMLS CUI [4])
Statins
Item
3. patients on statin treatment on the day of recruitment.
boolean
C0360714 (UMLS CUI [1])
Chemotherapy | Steroids
Item
4. patients on chemotherapy or receiving steroids.
boolean
C0392920 (UMLS CUI [1])
C0038317 (UMLS CUI [2])
Medical contraindication Statins
Item
5. patients with any contraindication to statin treatment:
boolean
C1301624 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Intolerance to Statins | Statin allergy
Item
known intolerance or hypersensitivity to statin.
boolean
C1744706 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
C0571873 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
sgot or sgpt above 1.5 times of upper normal level (unl).
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatine phosphokinase serum increased
Item
cpk above unl
boolean
C0241005 (UMLS CUI [1])
Macrolides | Antifungal Agents | Ketoconazole
Item
concomitant treatment with macrolides and or antifungal agents (ketoconazole)
boolean
C0282563 (UMLS CUI [1])
C0003308 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine level above 1.5 mg%
boolean
C0201976 (UMLS CUI [1])
Disease Severe | Disease Uncontrolled | Diabetic - poor control | Chronic Kidney Diseases | Communicable Disease Uncontrolled
Item
any severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0421258 (UMLS CUI [3])
C1561643 (UMLS CUI [4])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Second Primary Cancers | Exception Skin carcinoma | Exception Disease Free of
Item
6. patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years.
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Substance Use Disorders
Item
7. patients who have a history of alcohol or drug abuse.
boolean
C0038586 (UMLS CUI [1])
Protocol Compliance Unable
Item
8. patients who are mentally or physically unable to comply with all aspects of the study.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
9. participation to an investigational drug trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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