Date informed consent signed
Item
Date informed consent signed
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI [1])
CL Item
Afro-Caribbean (1)
CL Item
Other, specify (4)
If other race, please specify.
Item
If other race, please specify.
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
integer
C0001779 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Code List
1. Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
Item
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
integer
C0026764 (UMLS CUI [1])
C0162643 (UMLS CUI [2])
Code List
2. The subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
Item
3. The subject has measurable disease.
integer
C1513041 (UMLS CUI [1])
Code List
3. The subject has measurable disease.
Item
4. The subject has relapsed or relapsed/refractory disease. This must include at least one of the following criteria: Reappearance of serum or urinary paraprotein on immunofixation or routine electrophoresis confirmed by at least one follow-up and excluding oligoclonal immune reconstitution. ≥5% plasma cells in the bone marrow aspirate or biopsy. Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (not including compression fracture). Development of hypercalcemia (corrected serum calcium >11.5mg/dL or 2.8 mmol/L not attributable to any other cause)
integer
C0277556 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Code List
4. The subject has relapsed or relapsed/refractory disease. This must include at least one of the following criteria: Reappearance of serum or urinary paraprotein on immunofixation or routine electrophoresis confirmed by at least one follow-up and excluding oligoclonal immune reconstitution. ≥5% plasma cells in the bone marrow aspirate or biopsy. Development of new lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (not including compression fracture). Development of hypercalcemia (corrected serum calcium >11.5mg/dL or 2.8 mmol/L not attributable to any other cause)
Item
5. The subject has a life expectancy of greater than 6 months.
integer
C0023671 (UMLS CUI [1])
Code List
5. The subject has a life expectancy of greater than 6 months.
Item
6. The subject has an ECOG Performance status of 0 to 2.
integer
C1520224 (UMLS CUI [1])
Code List
6. The subject has an ECOG Performance status of 0 to 2.
Item
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
integer
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Code List
7. The subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
Item
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
integer
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0430456 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Code List
8. The subject has a normal 12-lead ECG or an ECG with abnormality considered to be clinically insignificant.
Item
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.
integer
C0565998 (UMLS CUI [1])
C2700391 (UMLS CUI [2,1])
C1507394 (UMLS CUI [2,2])
Code List
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.
Item
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
integer
C0085732 (UMLS CUI [1,1])
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])
Code List
10. The subject must be able to adhere to the study visit schedule and other protocol requirements.
Item
11. The subject must understand and voluntarily sign an informed consent document.
integer
C0021430 (UMLS CUI [1])
Code List
11. The subject must understand and voluntarily sign an informed consent document.
Item
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.
integer
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Code List
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.
Item
13. The subject must have Adequate end organ function, defined as the following: • Total bilirubin ≤ 2 x ULN, unless attributable to Gilbert’s disease • ALT (SGPT) and AST (SGOT) ≤ 2.5 x ULN • Creatinine < 2.0 x ULN • ANC ≥ 0.5 x 10 9 /L • Platelets ≥ 20,000 cells/mm 3
integer
C0678852 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0005821 (UMLS CUI [7])
Code List
13. The subject must have Adequate end organ function, defined as the following: • Total bilirubin ≤ 2 x ULN, unless attributable to Gilbert’s disease • ALT (SGPT) and AST (SGOT) ≤ 2.5 x ULN • Creatinine < 2.0 x ULN • ANC ≥ 0.5 x 10 9 /L • Platelets ≥ 20,000 cells/mm 3
Item
1. The subject has intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either compound, boron or mannitol or significant prior toxicity with either agent that would preclude the safe use of that agent. Prior therapy with either compound is permitted.
integer
C1744706 (UMLS CUI [1,1])
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])
Code List
1. The subject has intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either compound, boron or mannitol or significant prior toxicity with either agent that would preclude the safe use of that agent. Prior therapy with either compound is permitted.
Item
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
integer
C0006826 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0007117 (UMLS CUI [1,3])
C0553723 (UMLS CUI [1,4])
Code List
2. The subject has any other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
Item
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.
integer
C0009488 (UMLS CUI [1,1])
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])
Code List
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.
Item
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
integer
C0017178 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
Code List
4. The subject has a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
Item
5. If female, the subject is breast-feeding, pregnant, expects to become pregnant during the course of the study, or are sexually active in a heterosexual relationship and are not using a medically acceptable double barrier method birth control. Confirmation that the subject is not pregnant must be established by a negative serum β-hCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Women relying solely on oral contraceptives for birth control are excluded.
integer
C0006147 (UMLS CUI [1])
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])
Code List
5. If female, the subject is breast-feeding, pregnant, expects to become pregnant during the course of the study, or are sexually active in a heterosexual relationship and are not using a medically acceptable double barrier method birth control. Confirmation that the subject is not pregnant must be established by a negative serum β-hCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Women relying solely on oral contraceptives for birth control are excluded.
Item
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.
integer
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0877248 (UMLS CUI [4])
Code List
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.
Item
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.
integer
C0003392 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2])
C0020268 (UMLS CUI [3])
C0456388 (UMLS CUI [4])
Code List
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.
Item
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
integer
C0242295 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0073096 (UMLS CUI [3])
Code List
8. The subject is currently taking any investigational therapies and/or dietary supplements containing resveratrol.
Item
9. The subject has peripheral neuropathy of Grade 2 or greater.
integer
C0031117 (UMLS CUI [1])
Code List
9. The subject has peripheral neuropathy of Grade 2 or greater.
Item
10. The subject has uncontrolled bleeding.
integer
C0019080 (UMLS CUI [1])
Code List
10. The subject has uncontrolled bleeding.
Item
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory. (i.e.,unable to maintain a platelet count ≥ 20,000 cells/mm3).
integer
C2748540 (UMLS CUI [1])
C1390214 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
Code List
11. The subject has evidence of mucosal or internal bleeding and/or platelet refractory. (i.e.,unable to maintain a platelet count ≥ 20,000 cells/mm3).
Item
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.
integer
C0019046 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
Code List
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.
Item
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
integer
C0012634 (UMLS CUI [1])
C1853129 (UMLS CUI [2])
Code List
13. The subject has any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.