ID

30889

Descrição

Safety and Efficacy Study of Single Weekly Bortezomib in Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01090921

Link

https://clinicaltrials.gov/show/NCT01090921

Palavras-chave

Versões (3)
  1. 02/07/2018 02/07/2018 -
  2. 02/07/2018 02/07/2018 -
  3. 02/07/2018 02/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de julho de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01090921

Inglês

Eligibility Multiple Myeloma NCT01090921

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of multiple myeloma based on standard criteria.
Descrição

Multiple Myeloma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026764
2. measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1gm/dl and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
Descrição

Measurable Disease | m-spike Serum electrophoresis test | m-spike 24 Hour Urine Test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0241988
UMLS CUI [2,2]
C0851095
UMLS CUI [3,1]
C0241988
UMLS CUI [3,2]
C1255149
3. non-secretors must have measurable protein by freelite or measurable disease such as plasmacytoma to be eligible.
Descrição

Non-secretory myeloma | Protein Measurable | Other Coding | Measurable Disease | Plasmacytoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2,1]
C0033684
UMLS CUI [2,2]
C1513040
UMLS CUI [3]
C3846158
UMLS CUI [4]
C1513041
UMLS CUI [5]
C0032131
4. patient must not have been previously treated with chemotherapy. prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.
Descrição

Prior Chemotherapy Absent | Prior Therapy Hypercalcemia | Adrenal Cortex Hormones | Diphosphonates

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0020437
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0012544
5. patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:
Descrição

Ineligibility Transplantation of autologous hematopoietic stem cell

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C1831743
age>65
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
impaired renal function (creatinine≥2.0 mg/dl)
Descrição

Renal Insufficiency | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
impaired pulmonary function (dlco≤50%)
Descrição

Pulmonary function impairment | Carbon Monoxide Diffusing Capability Test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0858943
UMLS CUI [2]
C1516251
poor performance status (kps≤80)
Descrição

Poor performance status | Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1831741
UMLS CUI [2]
C0206065
other prohibitive comorbid disorder
Descrição

Comorbidity Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
5b. patients≥60 who decline autologous stem cell transplant are eligible for this study.
Descrição

Age | Autologous hematopoietic stem cell transplant Refused

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C2193200
UMLS CUI [2,2]
C1705116
5c. patients who are eligible but wish to postpone autologous stem cell transplant are eligible for this study.
Descrição

PATIENT WISH Autologous hematopoietic stem cell transplant Delay

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0747309
UMLS CUI [1,2]
C2193200
UMLS CUI [1,3]
C0205421
6. karnofsky performance status>50
Descrição

Karnofsky Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
7. patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period spot rt to ≤3 vertebrae acceptable prior to entry.
Descrição

Therapeutic radiology procedure Local | Exposure to Steroids | Absence Exposure to Steroids | Therapeutic radiology procedure Concurrent Completed | Washout Period Following | Therapeutic radiology procedure Vertebrae Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205276
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0038317
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C0038317
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205420
UMLS CUI [4,3]
C0205197
UMLS CUI [5,1]
C1710661
UMLS CUI [5,2]
C0332282
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0549207
UMLS CUI [6,3]
C1265611
8. meets the following pretreatment laboratory criteria at baseline (within 14 days prior to study drug administration):
Descrição

Laboratory Criteria pre treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C2709094
1. platelet count>50x10^9/l or, if the bone marrow is extensively infiltrated,>30x10^9/l
Descrição

Platelet Count measurement | Bone marrow infiltration Extensive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C3854434
UMLS CUI [2,2]
C0205231
2. hemoglobin>8.0g/dl
Descrição

Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518015
3. absolute neutrophil count >1.0x10^9/l or, if the bone marrow is extensively infiltrated, >0.5x10^9/l
Descrição

Absolute neutrophil count | Bone marrow infiltration Extensive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C3854434
UMLS CUI [2,2]
C0205231
9. meets the following pretreatment laboratory criteria for liver function tests at the screening visit conducted within 14 days of registration
Descrição

Laboratory Criteria pre treatment | Liver Function Tests

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C2709094
UMLS CUI [2]
C0023901
1. ast (sgot): <3 times the upper limit of institutional laboratory normal
Descrição

Aspartate aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201899
2. alt (sgpt): <3 times the upper limit of institutional laboratory normal
Descrição

Alanine aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
3. total bilirubin: <2 times the upper limit of institutional laboratory normal, unless clearly related to the disease
Descrição

Serum total bilirubin measurement | Exception Relationship Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0012634
10. women with child-bearing potential should be practicing an adequate form of contraception, as judged by the investigator (i.e. birth control pills, double barrier method, abstinence, etc.) or be surgically sterile or 12 months post-menopausal. male subject agrees to use an acceptable method for contraception for the duration of the study.
Descrição

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Barrier Contraception Double | Sexual Abstinence | Female Sterilization | Postmenopausal state | Gender Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3,1]
C0004764
UMLS CUI [3,2]
C0205173
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0232970
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0700589
11. age 18 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
12. has given voluntary written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (m-protein) and skin changes)
Descrição

POEMS Syndrome

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085404
2. plasma cell leukemia
Descrição

Leukemia, Plasma Cell

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023484
3. impaired kidney function requiring dialysis, patients on hemodialysis are excluded
Descrição

Renal Insufficiency Requirement Dialysis | Hemodialysis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
UMLS CUI [2]
C0019004
4. receiving steroids >the equivalent of 10mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
Descrição

Steroids Dosage | Prednisone U/day Equivalent | Other medical condition | Asthma | Lupus Erythematosus, Systemic | Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C0205163
UMLS CUI [3]
C3843040
UMLS CUI [4]
C0004096
UMLS CUI [5]
C0024141
UMLS CUI [6]
C0003873
5. infection not controlled by antibiotics
Descrição

Communicable Disease Uncontrolled | Antibiotics Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0003232
UMLS CUI [2,2]
C0332268
6. hiv infection. patients should provide consent for hiv testing according to the institution's standard practice
Descrição

HIV Infection | Consent HIV test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C1511481
UMLS CUI [2,2]
C1321876
7. known active hepatitis b or c
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
8. myocardial infarction within 6 months prior to enrollment or has new york heart association (nyha) class iii or iv heart failure (appendix d), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Descrição

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Cardiac conduction abnormality Electrocardiography

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
UMLS CUI [6,1]
C1842820
UMLS CUI [6,2]
C1623258
9. second malignancy requiring concurrent treatment
Descrição

Second Neoplasm Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C0332121
10. other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Descrição

Illness Serious Interferes with Treatment completion | Serious mental illness Interferes with Treatment completion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0580352
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0580352
11. positive pregnancy test in women of childbearing potential
Descrição

Childbearing Potential Pregnancy test positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0240802
12. patient has hypersensitivity to boron or mannitol.
Descrição

Hypersensitivity Boron | Mannitol allergy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006030
UMLS CUI [2]
C0571922
13. patient has ≥grade 2 peripheral neuropathy within 14 days before enrollment.
Descrição

Peripheral Neuropathy CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
14. patient has received other investigational drugs with 14 days before enrollment
Descrição

Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
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Eligibility Multiple Myeloma NCT01090921

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
1. diagnosis of multiple myeloma based on standard criteria.
boolean
C0026764 (UMLS CUI [1])
Measurable Disease | m-spike Serum electrophoresis test | m-spike 24 Hour Urine Test
Item
2. measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1gm/dl and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
boolean
C1513041 (UMLS CUI [1])
C0241988 (UMLS CUI [2,1])
C0851095 (UMLS CUI [2,2])
C0241988 (UMLS CUI [3,1])
C1255149 (UMLS CUI [3,2])
Non-secretory myeloma | Protein Measurable | Other Coding | Measurable Disease | Plasmacytoma
Item
3. non-secretors must have measurable protein by freelite or measurable disease such as plasmacytoma to be eligible.
boolean
C0456845 (UMLS CUI [1])
C0033684 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
C1513041 (UMLS CUI [4])
C0032131 (UMLS CUI [5])
Prior Chemotherapy Absent | Prior Therapy Hypercalcemia | Adrenal Cortex Hormones | Diphosphonates
Item
4. patient must not have been previously treated with chemotherapy. prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0020437 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0012544 (UMLS CUI [4])
Ineligibility Transplantation of autologous hematopoietic stem cell
Item
5. patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:
boolean
C1512714 (UMLS CUI [1,1])
C1831743 (UMLS CUI [1,2])
Age
Item
age>65
boolean
C0001779 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
impaired renal function (creatinine≥2.0 mg/dl)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Pulmonary function impairment | Carbon Monoxide Diffusing Capability Test
Item
impaired pulmonary function (dlco≤50%)
boolean
C0858943 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
Poor performance status | Karnofsky Performance Status
Item
poor performance status (kps≤80)
boolean
C1831741 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Comorbidity Excluded
Item
other prohibitive comorbid disorder
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Age | Autologous hematopoietic stem cell transplant Refused
Item
5b. patients≥60 who decline autologous stem cell transplant are eligible for this study.
boolean
C0001779 (UMLS CUI [1])
C2193200 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
PATIENT WISH Autologous hematopoietic stem cell transplant Delay
Item
5c. patients who are eligible but wish to postpone autologous stem cell transplant are eligible for this study.
boolean
C0747309 (UMLS CUI [1,1])
C2193200 (UMLS CUI [1,2])
C0205421 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
6. karnofsky performance status>50
boolean
C0206065 (UMLS CUI [1])
Therapeutic radiology procedure Local | Exposure to Steroids | Absence Exposure to Steroids | Therapeutic radiology procedure Concurrent Completed | Washout Period Following | Therapeutic radiology procedure Vertebrae Quantity
Item
7. patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period spot rt to ≤3 vertebrae acceptable prior to entry.
boolean
C1522449 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0038317 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4,1])
C0205420 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C1710661 (UMLS CUI [5,1])
C0332282 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C0549207 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
Laboratory Criteria pre treatment
Item
8. meets the following pretreatment laboratory criteria at baseline (within 14 days prior to study drug administration):
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
Platelet Count measurement | Bone marrow infiltration Extensive
Item
1. platelet count>50x10^9/l or, if the bone marrow is extensively infiltrated,>30x10^9/l
boolean
C0032181 (UMLS CUI [1])
C3854434 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
Hemoglobin measurement
Item
2. hemoglobin>8.0g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count | Bone marrow infiltration Extensive
Item
3. absolute neutrophil count >1.0x10^9/l or, if the bone marrow is extensively infiltrated, >0.5x10^9/l
boolean
C0948762 (UMLS CUI [1])
C3854434 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
Laboratory Criteria pre treatment | Liver Function Tests
Item
9. meets the following pretreatment laboratory criteria for liver function tests at the screening visit conducted within 14 days of registration
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
C0023901 (UMLS CUI [2])
Aspartate aminotransferase measurement
Item
1. ast (sgot): <3 times the upper limit of institutional laboratory normal
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
2. alt (sgpt): <3 times the upper limit of institutional laboratory normal
boolean
C0201836 (UMLS CUI [1])
Serum total bilirubin measurement | Exception Relationship Disease
Item
3. total bilirubin: <2 times the upper limit of institutional laboratory normal, unless clearly related to the disease
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Barrier Contraception Double | Sexual Abstinence | Female Sterilization | Postmenopausal state | Gender Contraceptive methods
Item
10. women with child-bearing potential should be practicing an adequate form of contraception, as judged by the investigator (i.e. birth control pills, double barrier method, abstinence, etc.) or be surgically sterile or 12 months post-menopausal. male subject agrees to use an acceptable method for contraception for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0004764 (UMLS CUI [3,1])
C0205173 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
Age
Item
11. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
12. has given voluntary written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
POEMS Syndrome
Item
1. poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (m-protein) and skin changes)
boolean
C0085404 (UMLS CUI [1])
Leukemia, Plasma Cell
Item
2. plasma cell leukemia
boolean
C0023484 (UMLS CUI [1])
Renal Insufficiency Requirement Dialysis | Hemodialysis
Item
3. impaired kidney function requiring dialysis, patients on hemodialysis are excluded
boolean
C1565489 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
C0019004 (UMLS CUI [2])
Steroids Dosage | Prednisone U/day Equivalent | Other medical condition | Asthma | Lupus Erythematosus, Systemic | Rheumatoid Arthritis
Item
4. receiving steroids >the equivalent of 10mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
boolean
C0038317 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C0024141 (UMLS CUI [5])
C0003873 (UMLS CUI [6])
Communicable Disease Uncontrolled | Antibiotics Lacking
Item
5. infection not controlled by antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003232 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
HIV Infection | Consent HIV test
Item
6. hiv infection. patients should provide consent for hiv testing according to the institution's standard practice
boolean
C0019693 (UMLS CUI [1])
C1511481 (UMLS CUI [2,1])
C1321876 (UMLS CUI [2,2])
Hepatitis B | Hepatitis C
Item
7. known active hepatitis b or c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Cardiac conduction abnormality Electrocardiography
Item
8. myocardial infarction within 6 months prior to enrollment or has new york heart association (nyha) class iii or iv heart failure (appendix d), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C1842820 (UMLS CUI [6,1])
C1623258 (UMLS CUI [6,2])
Second Neoplasm Treatment required for
Item
9. second malignancy requiring concurrent treatment
boolean
C0085183 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Illness Serious Interferes with Treatment completion | Serious mental illness Interferes with Treatment completion
Item
10. other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0580352 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0580352 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test positive
Item
11. positive pregnancy test in women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
Hypersensitivity Boron | Mannitol allergy
Item
12. patient has hypersensitivity to boron or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C0006030 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
13. patient has ≥grade 2 peripheral neuropathy within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Investigational New Drugs
Item
14. patient has received other investigational drugs with 14 days before enrollment
boolean
C0013230 (UMLS CUI [1])
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