ID

15552

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02343042

Palabras clave

Versiones (2)
  1. 3/6/16 3/6/16 -
  2. 3/6/16 3/6/16 - Julian Varghese
Subido en

3 de junio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Multiple Myeloma NCT02343042

Inglés

Eligibility Multiple Myeloma NCT02343042

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Diagnosis Histology | Measurable Disease | Multiple Myeloma | Disease Progression

Tipo de datos

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:
Descripción

Multiple Myeloma Symptomatic | Measurable Disease

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Excretion measurement M Protein In Urine

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Resolution Toxic effect Due to Pharmaceutical Preparations

Tipo de datos

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.
Descripción

Multiple Myeloma Relapsed | Refractory multiple myeloma

Tipo de datos

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoldering mm.
Descripción

Smoldering myeloma

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Primary amyloidosis of light chain type Systemic | Amyloid

Tipo de datos

boolean

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

Multiple Myeloma Involvement with Central Nervous System

Tipo de datos

boolean

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

Leukemia, Plasma Cell

Tipo de datos

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).
Descripción

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

Tipo de datos

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
Volver a la parte superior de la página

Similar models

Eligibility Multiple Myeloma NCT02343042

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial