ID

30862

Descripción

A Study of Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed Multiple Myeloma Previously Treated With Bortezomib; ODM derived from: https://clinicaltrials.gov/show/NCT00706953

Link

https://clinicaltrials.gov/show/NCT00706953

Palabras clave

Versiones (1)
  1. 28/6/18 28/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

28 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00706953

Inglés

Eligibility Multiple Myeloma NCT00706953

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of multiple myeloma
Descripción

Multiple Myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026764
received prior courses of bortezomib (velcade)-based therapy
Descripción

Bortezomib | Velcade

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C1174739
greater than or equal to 50% reduction in m-protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of velcade-based therapy
Descripción

M Protein Percentage Reduction | Disease Progression Absent | Velcade

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0392756
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C1174739
60 days or more since the patient's last velcade dose
Descripción

Velcade Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1174739
UMLS CUI [1,2]
C0178602
life expectancy > 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a >25% increase in m-protein
Descripción

Progressive Disease | Lytic lesion New | Lytic lesion Worsening | Plasmacytoma | Hypercalcemia | M Protein Increase Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0221204
UMLS CUI [2,2]
C0205314
UMLS CUI [3,1]
C0221204
UMLS CUI [3,2]
C0332271
UMLS CUI [4]
C0032131
UMLS CUI [5]
C0020437
UMLS CUI [6,1]
C0700271
UMLS CUI [6,2]
C0442805
UMLS CUI [6,3]
C0439165
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
no patients with progressive disease while receiving an anthracycline-based regimen
Descripción

Progressive Disease | Anthracyclines

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0282564
no patients with >2 prior regimens for the treatment of multiple myeloma
Descripción

Prior Therapy Quantity Multiple Myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0026764
no major surgery within 2 weeks before screening
Descripción

Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
no patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent
Descripción

Allergic Reaction Boron Compounds | Mannitol allergy | Allergic Reaction Anthracyclines | Allergic Reaction Liposomal agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0006031
UMLS CUI [2]
C0571922
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0282564
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1532143
no patients known to be human immunodeficiency virus (hiv) positive
Descripción

HIV Seropositivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
no patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness
Descripción

Poor hypertension control | Diabetes mellitus poor control | Illness Serious | Serious mental illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0860161
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C3841614
no patients with an active systemic infection requiring treatment
Descripción

Sepsis Treatment required for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0332121
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Similar models

Eligibility Multiple Myeloma NCT00706953

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
confirmed diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Bortezomib | Velcade
Item
received prior courses of bortezomib (velcade)-based therapy
boolean
C1176309 (UMLS CUI [1])
C1174739 (UMLS CUI [2])
M Protein Percentage Reduction | Disease Progression Absent | Velcade
Item
greater than or equal to 50% reduction in m-protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of velcade-based therapy
boolean
C0700271 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0392756 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1174739 (UMLS CUI [3])
Velcade Dose
Item
60 days or more since the patient's last velcade dose
boolean
C1174739 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Progressive Disease | Lytic lesion New | Lytic lesion Worsening | Plasmacytoma | Hypercalcemia | M Protein Increase Percentage
Item
progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a >25% increase in m-protein
boolean
C1335499 (UMLS CUI [1])
C0221204 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0221204 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0032131 (UMLS CUI [4])
C0020437 (UMLS CUI [5])
C0700271 (UMLS CUI [6,1])
C0442805 (UMLS CUI [6,2])
C0439165 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Progressive Disease | Anthracyclines
Item
no patients with progressive disease while receiving an anthracycline-based regimen
boolean
C1335499 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
Prior Therapy Quantity Multiple Myeloma
Item
no patients with >2 prior regimens for the treatment of multiple myeloma
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Major surgery
Item
no major surgery within 2 weeks before screening
boolean
C0679637 (UMLS CUI [1])
Allergic Reaction Boron Compounds | Mannitol allergy | Allergic Reaction Anthracyclines | Allergic Reaction Liposomal agent
Item
no patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C1527304 (UMLS CUI [3,1])
C0282564 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C1532143 (UMLS CUI [4,2])
HIV Seropositivity
Item
no patients known to be human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Poor hypertension control | Diabetes mellitus poor control | Illness Serious | Serious mental illness
Item
no patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness
boolean
C0421190 (UMLS CUI [1])
C0860161 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C3841614 (UMLS CUI [4])
Sepsis Treatment required for
Item
no patients with an active systemic infection requiring treatment
boolean
C0243026 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
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