Multiple Myeloma Symptomatic | Bone marrow plasma cells Percentage | biopsy tissue | Monoclonal Protein Serum | Monoclonal Protein In Urine | end organ damage
Item
participants diagnosed with symptomatic multiple myeloma based on the international myeloma working group (imwg) criteria; greater than or equal to 10 percent plasma cells in the bone marrow (or tissue biopsy) detected, monoclonal protein in the serum or urine and the, presence of end-organ injury
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2238293 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3864006 (UMLS CUI [3])
C0700271 (UMLS CUI [4,1])
C0229671 (UMLS CUI [4,2])
C0700271 (UMLS CUI [5,1])
C0042037 (UMLS CUI [5,2])
C0743496 (UMLS CUI [6])
Measurable Disease | Serum M Protein g/dL | Urine M Protein mg/day | Serum Free Light Chain Assay | Serum FLC Involved Level mg/dL | Serum FLC Ratio Abnormal | Bone marrow plasma cells Percentage
Item
participants with measurable disease defined by at least 1 of the following 5 measurements: a) serum m-protein greater than or equal to 1 gram per deciliter (g/dl), b) urine m protein greater than or equal to 200 milligram per 24 hour, c) serum free light chain (flc) assay: involved flc level greater than 10 mg per dl (mg/dl) provided serum flc ratio is abnormal, d) bone marrow plasma cells greater than or equal to 30 percent
boolean
C1513041 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0439267 (UMLS CUI [2,3])
C0042036 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0439422 (UMLS CUI [3,3])
C2827352 (UMLS CUI [4,1])
C1510438 (UMLS CUI [4,2])
C2827352 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0441889 (UMLS CUI [5,3])
C0439269 (UMLS CUI [5,4])
C2826181 (UMLS CUI [6])
C2238293 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
Chemotherapy Quantity Multiple Myeloma | Refractory Disease | Recurrent disease
Item
participants who received at least 1 prior line of chemotherapy for multiple myeloma and, is refractory to or has relapsed after the last therapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C1514815 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
Karnofsky Performance Status | ECOG performance status
Item
participants with karnofsky performance status greater than 60 or eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement Quantity
Item
participants with calculated or measured creatinine clearance of less than or equal to 30 mililiter per minute (ml/min). during the screening period, 2 measures of creatinine clearance at least 7 days apart must be obtained, and both must be less than 30 ml/min
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
bortezomib | Best Response Progressive Disease | Serious Event Quantity
Item
participants who had received bortezomib in previous clinical trial and best response was progressive disease or experienced one or more serious events
boolean
C1176309 (UMLS CUI [1])
C2986560 (UMLS CUI [2,1])
C1335499 (UMLS CUI [2,2])
C2826307 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Nitrosoureas | Adrenal Cortex Hormones intense | Immunotherapy | antibody therapy
Item
participants who received nitorsoureas within 6 weeks, or 2 consecutive weeks of intense corticosteroids, or immunotherapy or antibody therapy within 4 weeks before enrolment
boolean
C0028210 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3])
C0281176 (UMLS CUI [4])
Allergic Reaction Boron Compounds | Allergic Reaction Compound Containing Mannitol
Item
participants with history of allergic reaction attributable to compounds containing boron or mannitol
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0024730 (UMLS CUI [2,4])
Peripheral Neuropathy CTCAE Grades
Item
participants with peripheral neuropathy of grade 2 or greater intensity at the time of signing informed consent form
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female participants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])