ID

36455

Beschrijving

A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02497378

Link

https://clinicaltrials.gov/show/NCT02497378

Trefwoorden

Versies (1)
  1. 15-05-19 15-05-19 -
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See clinicaltrials.gov

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15 mei 2019

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02497378

Engels

Eligibility Multiple Myeloma NCT02497378

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants proven to have symptomatic (having symptoms) multiple myeloma (mm) according the international myeloma working group (imwg) diagnostic criteria
Beschrijving

Multiple Myeloma Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0032112
UMLS CUI [2,2]
C0746619
UMLS CUI [2,3]
C0005953
UMLS CUI [2,4]
C0439165
UMLS CUI [3,1]
C0032131
UMLS CUI [3,2]
C0005558
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0242485
UMLS CUI [5,1]
C2984963
UMLS CUI [5,2]
C0229671
UMLS CUI [6,1]
C2984963
UMLS CUI [6,2]
C0229671
UMLS CUI [6,3]
C0020835
UMLS CUI [7,1]
C2984963
UMLS CUI [7,2]
C0042037
UMLS CUI [7,3]
C0456209
UMLS CUI [8,1]
C2827352
UMLS CUI [8,2]
C0242485
UMLS CUI [9]
C2826181
participant must have received at least 1 prior line of therapy for mm
Beschrijving

Prior Therapy Quantity Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
participant must have an eastern cooperative oncology group (ecog) performance status score of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
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
Beschrijving

Partial response Prior Therapy Quantity | Complete response Prior Therapy Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1521726
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has received daratumumab or other anti-cluster of differentiation 38 (anti-cd38) therapies previously
Beschrijving

daratumumab | CD38 Monoclonal Antibody

Datatype

boolean

Alias
UMLS CUI [1]
C2346801
UMLS CUI [2,1]
C0075742
UMLS CUI [2,2]
C0003250
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
Beschrijving

Refractory Bortezomib | Refractory Proteasome inhibitor | Refractory Ixazomib | Refractory Carfilzomib

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C1443643
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C3273711
UMLS CUI [4,1]
C0205269
UMLS CUI [4,2]
C2001856
is intolerant to bortezomib (ie, discontinued due to any adverse event while on bortezomib treatment)
Beschrijving

Intolerance to Bortezomib

Datatype

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C1176309
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)
Beschrijving

Therapeutic procedure Multiple Myeloma | Exception Adrenal Cortex Hormones Emergency Situation | Exception Equivalent Dexamethasone U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0013956
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0011777
UMLS CUI [3,4]
C0456683
has a history of malignancy (other than multiple myeloma) within 3 years before the date of daratumumab first administration
Beschrijving

Malignant Neoplasms | Exception Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026764
has any concurrent medical condition or disease (eg, active systemic infection, pulmonary impairment) that is likely to interfere with study procedures
Beschrijving

Comorbidity Interferes with Clinical Trial procedure | Sepsis | Pulmonary function impairment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0184661
UMLS CUI [2]
C0243026
UMLS CUI [3]
C0858943
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Similar models

Eligibility Multiple Myeloma NCT02497378

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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