ID
44275
Description
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma
Keywords
Versions (2)
- 2/24/19 2/24/19 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556
Screening - Demography; Inclusion Criteria; Exclusion Criteria
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date informed consent signed
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Description
Subject Initials
Data type
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Check one box only
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
If other race, please specify.
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0021430
Description
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
Data type
integer
Alias
- UMLS CUI [1]
- C0026764
- UMLS CUI [2]
- C0162643
Description
3. The subject has measurable disease.
Data type
integer
Alias
- UMLS CUI [1]
- C1513041
Description
4. The subject has relapsed or relapsed/refractory disease
Data type
integer
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C0205269
Description
5. The subject has a life expectancy of greater than 6 months.
Data type
integer
Alias
- UMLS CUI [1]
- C0023671
Description
6. The subject has an ECOG Performance status of 0 to 2.
Data type
integer
Alias
- UMLS CUI [1]
- C1520224
Description
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
Data type
integer
Alias
- UMLS CUI [1]
- C0019682
- UMLS CUI [2]
- C0019163
- UMLS CUI [3]
- C0019196
Description
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205307
- UMLS CUI [1,3]
- C2826293
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C0205161
- UMLS CUI [2,3]
- C2826293
Description
9. The subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
Data type
integer
Alias
- UMLS CUI [1]
- C0565998
- UMLS CUI [2,1]
- C2700391
- UMLS CUI [2,2]
- C1507394
Description
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0085732
- UMLS CUI [1,2]
- C1321605
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C1512346
- UMLS CUI [1,5]
- C0086960
- UMLS CUI [1,6]
- C1709747
Description
11. The subject must understand and voluntarily sign an informed consent document.
Data type
integer
Alias
- UMLS CUI [1]
- C0021430
Description
12. If the subject is of reproductive potential, the subject must agree prior to study entry to use ad equate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
Data type
integer
Alias
- UMLS CUI [1,1]
- C4034483
- UMLS CUI [1,2]
- C0700589
Description
13. The subject must have Adequate end organ function
Data type
integer
Alias
- UMLS CUI [1]
- C0678852
- UMLS CUI [2]
- C0201913
- UMLS CUI [3]
- C0201836
- UMLS CUI [4]
- C0201899
- UMLS CUI [5]
- C0201976
- UMLS CUI [6]
- C0948762
- UMLS CUI [7]
- C0005821
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
1. Intolerance to resveratrol, SRT501, bortezomib, Boron, Mannitol or prior toxicity
Data type
integer
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0073096
- UMLS CUI [2,1]
- C1744706
- UMLS CUI [2,2]
- C2002402
- UMLS CUI [3,1]
- C1744706
- UMLS CUI [3,2]
- C1176309
- UMLS CUI [4,1]
- C1744706
- UMLS CUI [4,2]
- C0006030
- UMLS CUI [5,1]
- C1744706
- UMLS CUI [5,2]
- C0024730
- UMLS CUI [6]
- C0013221
Description
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0006826
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0007117
- UMLS CUI [1,4]
- C0553723
Description
3. The subject has an uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0205318
- UMLS CUI [2]
- C0009450
- UMLS CUI [3]
- C0018802
- UMLS CUI [4]
- C0002965
- UMLS CUI [5]
- C0003811
- UMLS CUI [6]
- C1735346
- UMLS CUI [7]
- C0265122
- UMLS CUI [8]
- C0004936
Description
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0017178
- UMLS CUI [1,2]
- C4054723
- UMLS CUI [1,3]
- C0678745
Description
5. Breast Feeding | Pregnancy | Sex Behavior | Contraceptive methods; Appropriate | Serum pregnancy test negative; Serum Beta-HCG Test | Postmenopausal state | Female Sterilization
Data type
integer
Alias
- UMLS CUI [1]
- C0006147
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0036864
- UMLS CUI [4,1]
- C0700589
- UMLS CUI [4,2]
- C1548787
- UMLS CUI [5,1]
- C0430061
- UMLS CUI [5,2]
- C1255526
- UMLS CUI [6]
- C0232970
- UMLS CUI [7]
- C0015787
Description
6. The subject has had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Data type
integer
Alias
- UMLS CUI [1]
- C0392920
- UMLS CUI [2]
- C1522449
- UMLS CUI [3]
- C0021430
- UMLS CUI [4]
- C0877248
Description
7. The subject is on concurrent medications that may exhibit anti-neoplastic therapy, with the exception of ≤10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0003392
- UMLS CUI [1,2]
- C2827774
- UMLS CUI [2]
- C0032952
- UMLS CUI [3]
- C0020268
- UMLS CUI [4]
- C0456388
Description
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
Data type
integer
Alias
- UMLS CUI [1]
- C0242295
- UMLS CUI [2]
- C0949266
- UMLS CUI [3]
- C0073096
Description
9. The subject has peripheral neuropathy of Grade 2 or greater.
Data type
integer
Alias
- UMLS CUI [1]
- C0031117
Description
10. The subject has uncontrolled bleeding.
Data type
integer
Alias
- UMLS CUI [1]
- C0019080
Description
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory.
Data type
integer
Alias
- UMLS CUI [1]
- C2748540
- UMLS CUI [2]
- C1390214
- UMLS CUI [3]
- C0005821
Description
12. The subject has a hemoglobin level less than < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.
Data type
integer
Alias
- UMLS CUI [1]
- C0019046
- UMLS CUI [2]
- C1879316
- UMLS CUI [3]
- C0014822
Description
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
Data type
integer
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1853129
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Screening - Demography; Inclusion Criteria; Exclusion Criteria
- StudyEvent: ODM
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C2986440 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0162643 (UMLS CUI [2])
C0205269 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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C0205161 (UMLS CUI [2,2])
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C1507394 (UMLS CUI [2,2])
C1321605 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1512346 (UMLS CUI [1,4])
C0086960 (UMLS CUI [1,5])
C1709747 (UMLS CUI [1,6])
C0700589 (UMLS CUI [1,2])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0005821 (UMLS CUI [7])
C0073096 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2002402 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1176309 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0006030 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0024730 (UMLS CUI [5,2])
C0013221 (UMLS CUI [6])
C1705847 (UMLS CUI [1,2])
C0007117 (UMLS CUI [1,3])
C0553723 (UMLS CUI [1,4])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C1735346 (UMLS CUI [6])
C0265122 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
C4054723 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2])
C0036864 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C0430061 (UMLS CUI [5,1])
C1255526 (UMLS CUI [5,2])
C0232970 (UMLS CUI [6])
C0015787 (UMLS CUI [7])
C1522449 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0877248 (UMLS CUI [4])
C2827774 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2])
C0020268 (UMLS CUI [3])
C0456388 (UMLS CUI [4])
C0949266 (UMLS CUI [2])
C0073096 (UMLS CUI [3])
C1390214 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C1879316 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
C1853129 (UMLS CUI [2])