Eligibility Multiple Myeloma NCT02497378

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic
Item
participants proven to have symptomatic (having symptoms) multiple myeloma (mm) according the international myeloma working group (imwg) diagnostic criteria
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Multiple Myeloma | Plasma Cells monoclonal Bone Marrow Percentage | Plasmacytoma Biopsy | Disease Measurement | M Protein Measurement Serum | M Protein Measurement Serum Immunoglobulin A | M Protein Measurement In Urine 24 hour urine sample | Serum Free Immunoglobulin Light Chain Measurement | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
participant must have documented mm as defined by following criteria: monoclonal plasma cells in the bone marrow 10 percent (%), or presence of a biopsy-proven plasmacytoma at some point in their disease history, disease measurements: a) serum m-protein greater than or equal to (>=) 1 gram per deciliter (g/dl) (>=10 gram per liter [g/l]) b) serum immunoglobulin a [iga] m-protein >= 0.5 g/dl); c) urine m-protein >=200 milligram per 24 hour (mg/24 h); d) serum immunoglobulin free light chain >=10 mg/dl and abnormal serum immunoglobulin kappa lambda free light chain ratio
boolean
C0026764 (UMLS CUI [1])
C0032112 (UMLS CUI [2,1])
C0746619 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
C0032131 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C2984963 (UMLS CUI [5,1])
C0229671 (UMLS CUI [5,2])
C2984963 (UMLS CUI [6,1])
C0229671 (UMLS CUI [6,2])
C0020835 (UMLS CUI [6,3])
C2984963 (UMLS CUI [7,1])
C0042037 (UMLS CUI [7,2])
C0456209 (UMLS CUI [7,3])
C2827352 (UMLS CUI [8,1])
C0242485 (UMLS CUI [8,2])
C2826181 (UMLS CUI [9])
Prior Therapy Quantity Multiple Myeloma
Item
participant must have received at least 1 prior line of therapy for mm
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
ECOG performance status
Item
participant must have an eastern cooperative oncology group (ecog) performance status score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Partial response Prior Therapy Quantity | Complete response Prior Therapy Quantity
Item
participant must have achieved a response (partial response [pr] or better based on investigator's determination of response by the imwg criteria) to at least 1 prior regimen
boolean
C1521726 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
daratumumab | CD38 Monoclonal Antibody
Item
participant has received daratumumab or other anti-cluster of differentiation 38 (anti-cd38) therapies previously
boolean
C2346801 (UMLS CUI [1])
C0075742 (UMLS CUI [2,1])
C0003250 (UMLS CUI [2,2])
Refractory Bortezomib | Refractory Proteasome inhibitor | Refractory Ixazomib | Refractory Carfilzomib
Item
is refractory to bortezomib or another pi, like ixazomib and carfilzomib (had progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another pi therapy, like ixazomib and carfilzomib
boolean
C0205269 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C1443643 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3,1])
C3273711 (UMLS CUI [3,2])
C0205269 (UMLS CUI [4,1])
C2001856 (UMLS CUI [4,2])
Intolerance to Bortezomib
Item
is intolerant to bortezomib (ie, discontinued due to any adverse event while on bortezomib treatment)
boolean
C1744706 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
Therapeutic procedure Multiple Myeloma | Exception Adrenal Cortex Hormones Emergency Situation | Exception Equivalent Dexamethasone U/day
Item
has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of daratumumab first administration. the only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. a list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the site investigational product procedures manual (ippm)
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0013956 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0011777 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
Malignant Neoplasms | Exception Multiple Myeloma
Item
has a history of malignancy (other than multiple myeloma) within 3 years before the date of daratumumab first administration
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
Comorbidity Interferes with Clinical Trial procedure | Sepsis | Pulmonary function impairment
Item
has any concurrent medical condition or disease (eg, active systemic infection, pulmonary impairment) that is likely to interfere with study procedures
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C0243026 (UMLS CUI [2])
C0858943 (UMLS CUI [3])
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