female postmenopausal; Contraception status; informed consent
Item
females that are postmenopausal for at least 1 year before the screening visit, surgically sterilized or if they are of childbearing potential agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose.
boolean
C0015780 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
C0015780 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
male; Contraception, Barrier; abstaining from sex
Item
male subjects must agree to practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
boolean
C0086582 (UMLS CUI [1])
C0004764 (UMLS CUI [2])
C1171321 (UMLS CUI [3])
Mantle cell lymphoma recurrent
Item
patients with newly diagnosed and relapsed mantle cell lymphoma.
boolean
C0677725 (UMLS CUI [1])
ecog
Item
ecog performance status grade 3 or higher.
boolean
C1520224 (UMLS CUI [1])
platelet count
Item
patient has a platelet count of <50x10 9/l within 14 days before enrollment if not related to disease.
boolean
C0032181 (UMLS CUI [1])
absolute neutrophil count
Item
patient has an absolute neutrophil count less than 100 within 14 days before enrollment if not related to disease.
boolean
C0948762 (UMLS CUI [1])
creatinine clearance
Item
patient has a calculated or measured creatinine clearance of <20 ml/minute within 14 days before enrollment.
boolean
C0373595 (UMLS CUI [1])
peripheral neuropathy
Item
patient has > grade 2 peripheral neuropathy within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1])
total bilirubin
Item
patient has > 1.5 x uln total bilirubin.
boolean
C0201913 (UMLS CUI [1])
myocardial infarction; New York Heart Association Classification; Angina Pectoris; ventricular arrhythmia; electrocardiography
Item
myocardial infarction within 6 months prior to enrollment or has new york heart association class ii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
boolean
C0027051 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0085612 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
hypersensitivity bortezomib boron mannitol
Item
patient has hypersensitivity to bortezomib, boron or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0006030 (UMLS CUI [1,3])
C0024730 (UMLS CUI [1,4])
pregnancy; lactating
Item
female subject is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
patient has received other investigational drugs within 14 days before enrollment.
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
malignancy; basal cell carcinoma; squamous cell carcinoma; prostate cancer
Item
diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0007137 (UMLS CUI [3])
C0600139 (UMLS CUI [4])