ID

15552

Beskrivning

Phase 1b/2 Study of Selinexor (KPT-330) in Combination w/ Backbone Treatments for Resistant/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02343042

Länk

https://clinicaltrials.gov/show/NCT02343042

Nyckelord

Versioner (2)
  1. 2016-06-03 2016-06-03 -
  2. 2016-06-03 2016-06-03 - Julian Varghese
Uppladdad den

3 juni 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT02343042

Engelsk

Eligibility Multiple Myeloma NCT02343042

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis, measurable disease and evidence of disease progression of multiple myeloma, as described below.
Beskrivning

Diagnosis Histology | Measurable Disease | Multiple Myeloma | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0344441
UMLS CUI [2]
C1513041
UMLS CUI [3]
C0026764
UMLS CUI [4]
C0242656
symptomatic multiple myeloma, based on imwg guidelines. patients must have measurable disease as defined by at least one of the following:
Beskrivning

Multiple Myeloma Symptomatic | Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1513041
1. serum m-protein ≥ 5 g/l by serum electrophoresis (spep) or for immunoglobulin a (iga) myeloma, by quantitative iga; or
Beskrivning

M Protein | Serum protein electrophoresis | IgA myeloma | Immunoglobulin A measurement Quantitative

Datatyp

boolean

Alias
UMLS CUI [1]
C0700271
UMLS CUI [2]
C0201720
UMLS CUI [3]
C0563305
UMLS CUI [4,1]
C0202083
UMLS CUI [4,2]
C0392762
2. urinary m-protein excretion at least 200 mg/24 hours; or
Beskrivning

Excretion measurement M Protein In Urine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201808
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0042037
3. involved serum free light chains ≥ 100 mg/l, provided that free light chain ratio is abnormal
Beskrivning

Serum Free Immunoglobulin Light Chain Involvement | Serum Immunoglobulin Free Light Chain Ratio Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2827352
UMLS CUI [1,2]
C1314939
UMLS CUI [2]
C2826181
4. if serum protein electrophoresis is felt to be unreliable for routine m-protein measurement, then quantitative immunoglobulin levels by nephelometry or turbidometry are acceptable.
Beskrivning

Serum protein electrophoresis unreliable | M Protein Measurement | Immunoglobulin level Quantitative | Nephelometry | Turbidimetry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0201720
UMLS CUI [1,2]
C0749770
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0242485
UMLS CUI [3,1]
C0428536
UMLS CUI [3,2]
C0392762
UMLS CUI [4]
C0027692
UMLS CUI [5]
C0041394
resolution of prior drug-related toxicities to ≤ grade 1.
Beskrivning

Resolution Toxic effect Due to Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0013227
relapsed and/or refractory multiple myeloma.
Beskrivning

Multiple Myeloma Relapsed | Refractory multiple myeloma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0205336
UMLS CUI [2]
C0278620
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoldering mm.
Beskrivning

Smoldering myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C1531608
multiple myeloma that does not express m-protein or free light chain(flc) (i.e., non-secretory mm is excluded), and quantitative immunoglobulin levels cannot be used instead.
Beskrivning

Multiple Myeloma | Gene Expression | M Protein | Free Immunoglobulin Light Chain | Non-secretory myeloma | Immunoglobulin level Quantitative

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0017262
UMLS CUI [3]
C0700271
UMLS CUI [4]
C0806492
UMLS CUI [5]
C0456845
UMLS CUI [6,1]
C0428536
UMLS CUI [6,2]
C0392762
documented systemic amyloid light chain amyloidosis.
Beskrivning

Primary amyloidosis of light chain type Systemic | Amyloid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0342606
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0002716
active mm involving the central nervous system (cns).
Beskrivning

Multiple Myeloma Involvement with Central Nervous System

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C3714787
plasma cell leukemia.
Beskrivning

Leukemia, Plasma Cell

Datatyp

boolean

Alias
UMLS CUI [1]
C0023484
on the selinexor + dexamethasone + bortezomib (sdb) arm only: prior history of neuropathy grade > 2, or grade 2 neuropathy with pain at baseline (within 14 days prior to cycle 1 day 1).
Beskrivning

Protocol Treatment Arm selinexor Dexamethasone bortezomib | Neuropathy | Neuropathy, Painful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C3852671
UMLS CUI [1,3]
C0011777
UMLS CUI [1,4]
C1176309
UMLS CUI [2]
C0442874
UMLS CUI [3]
C1850383
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Similar models

Eligibility Multiple Myeloma NCT02343042

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis Histology | Measurable Disease | Multiple Myeloma | Disease Progression
Item
histologically confirmed diagnosis, measurable disease and evidence of disease progression of multiple myeloma, as described below.
boolean
C0011900 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2])
C0026764 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
Multiple Myeloma Symptomatic | Measurable Disease
Item
symptomatic multiple myeloma, based on imwg guidelines. patients must have measurable disease as defined by at least one of the following:
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2])
M Protein | Serum protein electrophoresis | IgA myeloma | Immunoglobulin A measurement Quantitative
Item
1. serum m-protein ≥ 5 g/l by serum electrophoresis (spep) or for immunoglobulin a (iga) myeloma, by quantitative iga; or
boolean
C0700271 (UMLS CUI [1])
C0201720 (UMLS CUI [2])
C0563305 (UMLS CUI [3])
C0202083 (UMLS CUI [4,1])
C0392762 (UMLS CUI [4,2])
Excretion measurement M Protein In Urine
Item
2. urinary m-protein excretion at least 200 mg/24 hours; or
boolean
C0201808 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0042037 (UMLS CUI [1,3])
Serum Free Immunoglobulin Light Chain Involvement | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
3. involved serum free light chains ≥ 100 mg/l, provided that free light chain ratio is abnormal
boolean
C2827352 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2826181 (UMLS CUI [2])
Serum protein electrophoresis unreliable | M Protein Measurement | Immunoglobulin level Quantitative | Nephelometry | Turbidimetry
Item
4. if serum protein electrophoresis is felt to be unreliable for routine m-protein measurement, then quantitative immunoglobulin levels by nephelometry or turbidometry are acceptable.
boolean
C0201720 (UMLS CUI [1,1])
C0749770 (UMLS CUI [1,2])
C0700271 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C0428536 (UMLS CUI [3,1])
C0392762 (UMLS CUI [3,2])
C0027692 (UMLS CUI [4])
C0041394 (UMLS CUI [5])
Resolution Toxic effect Due to Pharmaceutical Preparations
Item
resolution of prior drug-related toxicities to ≤ grade 1.
boolean
C1514893 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Multiple Myeloma Relapsed | Refractory multiple myeloma
Item
relapsed and/or refractory multiple myeloma.
boolean
C0026764 (UMLS CUI [1,1])
C0205336 (UMLS CUI [1,2])
C0278620 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Smoldering myeloma
Item
smoldering mm.
boolean
C1531608 (UMLS CUI [1])
Multiple Myeloma | Gene Expression | M Protein | Free Immunoglobulin Light Chain | Non-secretory myeloma | Immunoglobulin level Quantitative
Item
multiple myeloma that does not express m-protein or free light chain(flc) (i.e., non-secretory mm is excluded), and quantitative immunoglobulin levels cannot be used instead.
boolean
C0026764 (UMLS CUI [1])
C0017262 (UMLS CUI [2])
C0700271 (UMLS CUI [3])
C0806492 (UMLS CUI [4])
C0456845 (UMLS CUI [5])
C0428536 (UMLS CUI [6,1])
C0392762 (UMLS CUI [6,2])
Primary amyloidosis of light chain type Systemic | Amyloid
Item
documented systemic amyloid light chain amyloidosis.
boolean
C0342606 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0002716 (UMLS CUI [2])
Multiple Myeloma Involvement with Central Nervous System
Item
active mm involving the central nervous system (cns).
boolean
C0026764 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
Leukemia, Plasma Cell
Item
plasma cell leukemia.
boolean
C0023484 (UMLS CUI [1])
Protocol Treatment Arm selinexor Dexamethasone bortezomib | Neuropathy | Neuropathy, Painful
Item
on the selinexor + dexamethasone + bortezomib (sdb) arm only: prior history of neuropathy grade > 2, or grade 2 neuropathy with pain at baseline (within 14 days prior to cycle 1 day 1).
boolean
C1522541 (UMLS CUI [1,1])
C3852671 (UMLS CUI [1,2])
C0011777 (UMLS CUI [1,3])
C1176309 (UMLS CUI [1,4])
C0442874 (UMLS CUI [2])
C1850383 (UMLS CUI [3])
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