Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Myeloma | Recurrent disease | Multiple myeloma in relapse | Refractory multiple myeloma
Item
must have received prior therapy for their myeloma and have relapsed and/or relapsed/refractory multiple myeloma
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C2349261 (UMLS CUI [3])
C0278620 (UMLS CUI [4])
Monoclonal protein Serum | Monoclonal free light chain present Urine protein electrophoresis | Immunoglobulin Light Chain Measurable Free Immunoglobulin Light Chain Assay | Plasmacytoma Measurable
Item
monoclonal protein in the serum of greater than or equal to 1 gm/dl or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200mg/24 hours, or measurable light chains by free light chain assay of greater than or equal to 10mg/dl, or measurable plasmacytoma
boolean
C0700271 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C1532998 (UMLS CUI [2,1])
C0201721 (UMLS CUI [2,2])
C0021038 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0806492 (UMLS CUI [3,3])
C1510438 (UMLS CUI [3,4])
C0032131 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
ECOG performance status
Item
ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Study Protocol
Item
laboratory values as outlined in the protocol
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cytotoxic Chemotherapy | Biological treatment | Adrenal Cortex Hormones | Adrenal Cortex Hormones chronic | Myeloma Excluded
Item
cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma.
boolean
C0677881 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0026764 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
men or women of childbearing potential who are unwilling to employ adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational Therapy Ancillary
Item
other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational within 14 days before enrollment
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0949266 (UMLS CUI [4,1])
C1549485 (UMLS CUI [4,2])
HIV Seropositivity
Item
known to be hiv positive
boolean
C0019699 (UMLS CUI [1])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography
Item
myocardial infarction within 6 months prior to enrollment or has nyha class iii or iv hear failure, 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])
C0151236 (UMLS CUI [6,1])
C1623258 (UMLS CUI [6,2])
Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
hypersensitivity to bortezomib, boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical trial
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Live Vaccines Immunization Patient need for | Live Vaccines Immunization
Item
patients who may need or are receiving live vaccines for immunization
boolean
C0042211 (UMLS CUI [1,1])
C0020971 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0042211 (UMLS CUI [2,1])
C0020971 (UMLS CUI [2,2])