ID

30863

Beschreibung

Study of the Safety and Pharmacokinetics of Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function; ODM derived from: https://clinicaltrials.gov/show/NCT00721734

Link

https://clinicaltrials.gov/show/NCT00721734

Stichworte

Versionen (1)
  1. 28.06.18 28.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Juni 2018

DOI

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Lizenz

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Eligibility Multiple Myeloma NCT00721734

Englisch

Eligibility Multiple Myeloma NCT00721734

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent in accordance with federal, local, and institutional guidelines
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. males and females ≥ 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. multiple myeloma
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
4. documented relapsed or progressive disease (pd) after receiving at least two prior treatment regimens (induction therapy with autologous stem cell transplant and maintenance is considered a single regimen), and must have achieved a minimal response or better to at least one of the regimens
Beschreibung

Recurrent disease | Progressive Disease | Status post Therapeutic procedure Quantity | Neoadjuvant Therapy | Autologous hematopoietic stem cell transplant | Response Minimal

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0600558
UMLS CUI [5]
C2193200
UMLS CUI [6,1]
C1704632
UMLS CUI [6,2]
C0547040
5. current measurable disease, as indicated by one or more of the following:
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
serum m-protein ≥ 0.5 g/dl
Beschreibung

Serum M Protein Level

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0441889
urine m-protein ≥ 200 mg/24 hours
Beschreibung

M Protein 24 hour urine measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C1443564
serum free light chain assay : involved flc level ≥ 10 mg/dl provided serum flc ratio is abnormal
Beschreibung

Serum Free Immunoglobulin Light Chain Assay | Serum Immunoglobulin Free Light Chain Ratio Abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2827352
UMLS CUI [1,2]
C1510438
UMLS CUI [2]
C2826181
6. life expectancy of more than three months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
7. eastern cooperative oncology group (ecog) performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
8. adequate hepatic function, with bilirubin < 2 times the upper limit of normal (uln) and alanine aminotransferase (alt) < 3 times uln
Beschreibung

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
9. total white blood cell (wbc) count ≥ 2,000/mm3
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
10. absolute neutrophil count (anc) ≥ 1,000/mm3
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
11. hemoglobin ≥ 7 gm/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
subjects may receive red blood cell (rbc) transfusions or supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
Beschreibung

Red Blood Cell Transfusion | Supportive care | Erythropoietin | Darbepoetin alfa

Datentyp

boolean

Alias
UMLS CUI [1]
C0086252
UMLS CUI [2]
C0344211
UMLS CUI [3]
C0014822
UMLS CUI [4]
C0937950
12. platelet count ≥ 30,000/ mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
13. female subjects of child-bearing potential must have a negative serum pregnancy test within seven days of the first dose and agree to use dual methods of contraception during and for 3 months following last dose of drug. post menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Double | Postmenopausal state | Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0205173
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
14. male subjects must use an effective barrier method of contraception during study and for three months following the last dose if sexually active with a female of child-bearing potential
Beschreibung

Gender Barrier Contraception | Gender Sexually active Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C3831118
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. glucocorticoid therapy in a dose equivalent to prednisone ≥ 20 mg/day within 14 days prior to first dose of study drug
Beschreibung

Glucocorticoid therapy Dose Prednisone Equivalent | Prednisone U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0744425
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0032952
UMLS CUI [1,4]
C0205163
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
2. poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Beschreibung

POEMS Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0085404
3. plasma cell leukemia
Beschreibung

Leukemia, Plasma Cell

Datentyp

boolean

Alias
UMLS CUI [1]
C0023484
4. chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy dose as defined above, within 14 days prior to first dose of study drug or antibody therapy within 6 weeks prior to first dose of study drug
Beschreibung

Chemotherapy Cancer treatment | Chemotherapy Cancer treatment Investigational | Steroid therapy Dose | Antibody therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0920425
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C1517586
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0178602
UMLS CUI [4]
C0281176
5. radiation therapy or immunotherapy within 3 weeks prior to first dose; localized radiation therapy within 1 week prior to first dose
Beschreibung

Therapeutic radiology procedure | Immunotherapy | Therapeutic radiology procedure Localized

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0021083
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0392752
6. participation in an investigational therapeutic study within 14 days prior to first dose of study drug
Beschreibung

Study Subject Participation Status | Therapy, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
7. prior carfilzomib treatment
Beschreibung

carfilzomib

Datentyp

boolean

Alias
UMLS CUI [1]
C2001856
8. pregnant or lactating females
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. major surgery within 3 weeks prior to first dose of study drug
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
10. congestive heart failure (new york heart association class iii to iv), symptomatic ischemia, conduction abnormalities or myocardial infarction in the three months prior to first dose of study drug
Beschreibung

Congestive heart failure New York Heart Association Classification | Ischemia Symptomatic | Cardiac conduction abnormality | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0022116
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C1842820
UMLS CUI [4]
C0027051
11. uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
12. recent history of acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose of study drug
Beschreibung

Communicable Disease Requirement Antibiotics for systemic use | Communicable Disease Requirement ANTIVIRALS FOR SYSTEMIC USE | Communicable Disease Requirement ANTIFUNGALS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3540704
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C3653777
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C3653743
13. known or suspected hiv infection, known hiv seropositivity
Beschreibung

HIV Infection | HIV Infection Suspected | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0019699
14. active hepatitis a, b, or c infection
Beschreibung

Hepatitis A | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
15. other malignancy within the past 3 years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer < gleason grade 7 with stable prostate specific antigen (psa) levels
Beschreibung

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Gleason Grading System | Exception Prostate carcinoma PSA Level Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C0332326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [6,3]
C4086720
UMLS CUI [6,4]
C0205360
16. any clinically significant medical or psychiatric disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Beschreibung

Disease Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Mental disorder Interferes with Protocol Compliance | Mental disorder Interferes with Informed Consent | Medical condition Interferes with Protocol Compliance | Medical condition Interferes with Informed Consent | Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0021430
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0021430
17. significant neuropathy (grade 3, grade 4, or grade 2 with pain) at the time of the first dose and/or within 14 days prior to enrollment
Beschreibung

Neuropathy CTCAE Grades | Painful Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1850383
UMLS CUI [2,2]
C1516728
18. subjects in whom the required program of oral hydration and intravenous fluid hydration is contraindicated, e.g., due to preexisting pulmonary or cardiac impairment
Beschreibung

Medical contraindication Hydration Therapy Oral | Medical contraindication Hydration Therapy Intravenous | Pulmonary function impairment Pre-existing | Decreased cardiac function Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1881074
UMLS CUI [1,3]
C0442027
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1881074
UMLS CUI [2,3]
C0348016
UMLS CUI [3,1]
C0858943
UMLS CUI [3,2]
C2347662
UMLS CUI [4,1]
C0232166
UMLS CUI [4,2]
C2347662
19. subjects with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis
Beschreibung

Pleural effusion Requirement Thoracentesis | Ascites Requirement Thoracentesis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0189477
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0189477
20. subjects with a known contraindication to receiving dexamethasone or allopurinol
Beschreibung

Medical contraindication Dexamethasone | Medical contraindication Allopurinol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0011777
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0002144
21. receipt of granulocyte- and granulocyte/ macrophage- colony stimulating factor (g-csf and gm-csf) within 1 week prior to first dose of study drug
Beschreibung

Granulocyte Colony-Stimulating Factor | Macrophage Colony-Stimulating Factor

Datentyp

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0079784
22. receipt of pegylated g-csf within 2 weeks prior to first dose of study drug
Beschreibung

Pegylated granulocyte colony-stimulating factor

Datentyp

boolean

Alias
UMLS CUI [1]
C1452552
23. rbc and platelet transfusions within 7 days prior to first dose of study drug
Beschreibung

Red Blood Cell Transfusion | Platelet Transfusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0086252
UMLS CUI [2]
C0086818
24. subjects with known or suspected cardiac amyloidosis
Beschreibung

Cardiac amyloidosis | Cardiac amyloidosis Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0268407
UMLS CUI [2,1]
C0268407
UMLS CUI [2,2]
C0750491
25. subjects with myelodysplastic syndrome
Beschreibung

MYELODYSPLASTIC SYNDROME

Datentyp

boolean

Alias
UMLS CUI [1]
C3463824
26. subjects undergoing peritoneal dialysis
Beschreibung

Peritoneal Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0031139
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00721734

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. written informed consent in accordance with federal, local, and institutional guidelines
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. males and females ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma
Item
3. multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Recurrent disease | Progressive Disease | Status post Therapeutic procedure Quantity | Neoadjuvant Therapy | Autologous hematopoietic stem cell transplant | Response Minimal
Item
4. documented relapsed or progressive disease (pd) after receiving at least two prior treatment regimens (induction therapy with autologous stem cell transplant and maintenance is considered a single regimen), and must have achieved a minimal response or better to at least one of the regimens
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0600558 (UMLS CUI [4])
C2193200 (UMLS CUI [5])
C1704632 (UMLS CUI [6,1])
C0547040 (UMLS CUI [6,2])
Measurable Disease
Item
5. current measurable disease, as indicated by one or more of the following:
boolean
C1513041 (UMLS CUI [1])
Serum M Protein Level
Item
serum m-protein ≥ 0.5 g/dl
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
M Protein 24 hour urine measurement
Item
urine m-protein ≥ 200 mg/24 hours
boolean
C0700271 (UMLS CUI [1,1])
C1443564 (UMLS CUI [1,2])
Serum Free Immunoglobulin Light Chain Assay | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
serum free light chain assay : involved flc level ≥ 10 mg/dl provided serum flc ratio is abnormal
boolean
C2827352 (UMLS CUI [1,1])
C1510438 (UMLS CUI [1,2])
C2826181 (UMLS CUI [2])
Life Expectancy
Item
6. life expectancy of more than three months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement
Item
8. adequate hepatic function, with bilirubin < 2 times the upper limit of normal (uln) and alanine aminotransferase (alt) < 3 times uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
White Blood Cell Count procedure
Item
9. total white blood cell (wbc) count ≥ 2,000/mm3
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
10. absolute neutrophil count (anc) ≥ 1,000/mm3
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
11. hemoglobin ≥ 7 gm/dl
boolean
C0518015 (UMLS CUI [1])
Red Blood Cell Transfusion | Supportive care | Erythropoietin | Darbepoetin alfa
Item
subjects may receive red blood cell (rbc) transfusions or supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
boolean
C0086252 (UMLS CUI [1])
C0344211 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
C0937950 (UMLS CUI [4])
Platelet Count measurement
Item
12. platelet count ≥ 30,000/ mm3
boolean
C0032181 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Double | Postmenopausal state | Female Sterilization
Item
13. female subjects of child-bearing potential must have a negative serum pregnancy test within seven days of the first dose and agree to use dual methods of contraception during and for 3 months following last dose of drug. post menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from a pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Gender Barrier Contraception | Gender Sexually active Childbearing Potential
Item
14. male subjects must use an effective barrier method of contraception during study and for three months following the last dose if sexually active with a female of child-bearing potential
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Glucocorticoid therapy Dose Prednisone Equivalent | Prednisone U/day
Item
1. glucocorticoid therapy in a dose equivalent to prednisone ≥ 20 mg/day within 14 days prior to first dose of study drug
boolean
C0744425 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
C0205163 (UMLS CUI [1,4])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
POEMS Syndrome
Item
2. poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
boolean
C0085404 (UMLS CUI [1])
Leukemia, Plasma Cell
Item
3. plasma cell leukemia
boolean
C0023484 (UMLS CUI [1])
Chemotherapy Cancer treatment | Chemotherapy Cancer treatment Investigational | Steroid therapy Dose | Antibody therapy
Item
4. chemotherapy with approved or investigative anticancer therapeutics, including steroid therapy dose as defined above, within 14 days prior to first dose of study drug or antibody therapy within 6 weeks prior to first dose of study drug
boolean
C0392920 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
C0149783 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0281176 (UMLS CUI [4])
Therapeutic radiology procedure | Immunotherapy | Therapeutic radiology procedure Localized
Item
5. radiation therapy or immunotherapy within 3 weeks prior to first dose; localized radiation therapy within 1 week prior to first dose
boolean
C1522449 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
Study Subject Participation Status | Therapy, Investigational
Item
6. participation in an investigational therapeutic study within 14 days prior to first dose of study drug
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
carfilzomib
Item
7. prior carfilzomib treatment
boolean
C2001856 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
8. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Major surgery
Item
9. major surgery within 3 weeks prior to first dose of study drug
boolean
C0679637 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification | Ischemia Symptomatic | Cardiac conduction abnormality | Myocardial Infarction
Item
10. congestive heart failure (new york heart association class iii to iv), symptomatic ischemia, conduction abnormalities or myocardial infarction in the three months prior to first dose of study drug
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0022116 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1842820 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Uncontrolled hypertension
Item
11. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Communicable Disease Requirement Antibiotics for systemic use | Communicable Disease Requirement ANTIVIRALS FOR SYSTEMIC USE | Communicable Disease Requirement ANTIFUNGALS FOR SYSTEMIC USE
Item
12. recent history of acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose of study drug
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3540704 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C3653777 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3653743 (UMLS CUI [3,3])
HIV Infection | HIV Infection Suspected | HIV Seropositivity
Item
13. known or suspected hiv infection, known hiv seropositivity
boolean
C0019693 (UMLS CUI [1])
C0019693 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
Hepatitis A | Hepatitis B | Hepatitis C
Item
14. active hepatitis a, b, or c infection
boolean
C0019159 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Gleason Grading System | Exception Prostate carcinoma PSA Level Stable
Item
15. other malignancy within the past 3 years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer < gleason grade 7 with stable prostate specific antigen (psa) levels
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C0332326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C4086720 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
Disease Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Mental disorder Interferes with Protocol Compliance | Mental disorder Interferes with Informed Consent | Medical condition Interferes with Protocol Compliance | Medical condition Interferes with Informed Consent | Mental condition Interferes with Protocol Compliance | Mental condition Interferes with Informed Consent
Item
16. any clinically significant medical or psychiatric disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C3840291 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0021430 (UMLS CUI [8,3])
Neuropathy CTCAE Grades | Painful Neuropathy CTCAE Grades
Item
17. significant neuropathy (grade 3, grade 4, or grade 2 with pain) at the time of the first dose and/or within 14 days prior to enrollment
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1850383 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Medical contraindication Hydration Therapy Oral | Medical contraindication Hydration Therapy Intravenous | Pulmonary function impairment Pre-existing | Decreased cardiac function Pre-existing
Item
18. subjects in whom the required program of oral hydration and intravenous fluid hydration is contraindicated, e.g., due to preexisting pulmonary or cardiac impairment
boolean
C1301624 (UMLS CUI [1,1])
C1881074 (UMLS CUI [1,2])
C0442027 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C1881074 (UMLS CUI [2,2])
C0348016 (UMLS CUI [2,3])
C0858943 (UMLS CUI [3,1])
C2347662 (UMLS CUI [3,2])
C0232166 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
Pleural effusion Requirement Thoracentesis | Ascites Requirement Thoracentesis
Item
19. subjects with pleural effusions requiring routine thoracentesis or ascites requiring routine paracentesis
boolean
C0032227 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0189477 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0189477 (UMLS CUI [2,3])
Medical contraindication Dexamethasone | Medical contraindication Allopurinol
Item
20. subjects with a known contraindication to receiving dexamethasone or allopurinol
boolean
C1301624 (UMLS CUI [1,1])
C0011777 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0002144 (UMLS CUI [2,2])
Granulocyte Colony-Stimulating Factor | Macrophage Colony-Stimulating Factor
Item
21. receipt of granulocyte- and granulocyte/ macrophage- colony stimulating factor (g-csf and gm-csf) within 1 week prior to first dose of study drug
boolean
C0079459 (UMLS CUI [1])
C0079784 (UMLS CUI [2])
Pegylated granulocyte colony-stimulating factor
Item
22. receipt of pegylated g-csf within 2 weeks prior to first dose of study drug
boolean
C1452552 (UMLS CUI [1])
Red Blood Cell Transfusion | Platelet Transfusion
Item
23. rbc and platelet transfusions within 7 days prior to first dose of study drug
boolean
C0086252 (UMLS CUI [1])
C0086818 (UMLS CUI [2])
Cardiac amyloidosis | Cardiac amyloidosis Suspected
Item
24. subjects with known or suspected cardiac amyloidosis
boolean
C0268407 (UMLS CUI [1])
C0268407 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
MYELODYSPLASTIC SYNDROME
Item
25. subjects with myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
Peritoneal Dialysis
Item
26. subjects undergoing peritoneal dialysis
boolean
C0031139 (UMLS CUI [1])
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