ID

24629

Beskrivning

Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00483262

Länk

https://clinicaltrials.gov/show/NCT00483262

Nyckelord

Versioner (1)
  1. 2017-08-10 2017-08-10 -
Uppladdad den

10 augusti 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00483262

Engelsk

Eligibility Multiple Myeloma NCT00483262

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
must have received prior therapy for their myeloma and have relapsed and/or relapsed/refractory multiple myeloma
Beskrivning

Therapeutic procedure Myeloma | Recurrent disease | Multiple myeloma in relapse | Refractory multiple myeloma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3]
C2349261
UMLS CUI [4]
C0278620
monoclonal protein in the serum of greater than or equal to 1 gm/dl or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200mg/24 hours, or measurable light chains by free light chain assay of greater than or equal to 10mg/dl, or measurable plasmacytoma
Beskrivning

Monoclonal protein Serum | Monoclonal free light chain present Urine protein electrophoresis | Immunoglobulin Light Chain Measurable Free Immunoglobulin Light Chain Assay | Plasmacytoma Measurable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0229671
UMLS CUI [2,1]
C1532998
UMLS CUI [2,2]
C0201721
UMLS CUI [3,1]
C0021038
UMLS CUI [3,2]
C1513040
UMLS CUI [3,3]
C0806492
UMLS CUI [3,4]
C1510438
UMLS CUI [4,1]
C0032131
UMLS CUI [4,2]
C1513040
ecog performance status 0, 1 or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
laboratory values as outlined in the protocol
Beskrivning

Laboratory Results Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled infection
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma.
Beskrivning

Cytotoxic Chemotherapy | Biological treatment | Adrenal Cortex Hormones | Adrenal Cortex Hormones chronic | Myeloma Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0001617
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0026764
UMLS CUI [5,2]
C2828389
pregnant or nursing women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
men or women of childbearing potential who are unwilling to employ adequate contraception
Beskrivning

Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational within 14 days before enrollment
Beskrivning

Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational Therapy Ancillary

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0949266
UMLS CUI [4,2]
C1549485
known to be hiv positive
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
myocardial infarction within 6 months prior to enrollment or has nyha class iii or iv hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Beskrivning

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
UMLS CUI [6,1]
C0151236
UMLS CUI [6,2]
C1623258
hypersensitivity to bortezomib, boron or mannitol
Beskrivning

Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3]
C0571922
serious medical or psychiatric illness likely to interfere with participation in this clinical trial
Beskrivning

Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
patients who may need or are receiving live vaccines for immunization
Beskrivning

Live Vaccines Immunization Patient need for | Live Vaccines Immunization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042211
UMLS CUI [1,2]
C0020971
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0042211
UMLS CUI [2,2]
C0020971
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Similar models

Eligibility Multiple Myeloma NCT00483262

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Myeloma | Recurrent disease | Multiple myeloma in relapse | Refractory multiple myeloma
Item
must have received prior therapy for their myeloma and have relapsed and/or relapsed/refractory multiple myeloma
boolean
C0087111 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C2349261 (UMLS CUI [3])
C0278620 (UMLS CUI [4])
Monoclonal protein Serum | Monoclonal free light chain present Urine protein electrophoresis | Immunoglobulin Light Chain Measurable Free Immunoglobulin Light Chain Assay | Plasmacytoma Measurable
Item
monoclonal protein in the serum of greater than or equal to 1 gm/dl or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200mg/24 hours, or measurable light chains by free light chain assay of greater than or equal to 10mg/dl, or measurable plasmacytoma
boolean
C0700271 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C1532998 (UMLS CUI [2,1])
C0201721 (UMLS CUI [2,2])
C0021038 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0806492 (UMLS CUI [3,3])
C1510438 (UMLS CUI [3,4])
C0032131 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
ECOG performance status
Item
ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Study Protocol
Item
laboratory values as outlined in the protocol
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cytotoxic Chemotherapy | Biological treatment | Adrenal Cortex Hormones | Adrenal Cortex Hormones chronic | Myeloma Excluded
Item
cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration. patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma.
boolean
C0677881 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0026764 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
men or women of childbearing potential who are unwilling to employ adequate contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational Therapy Ancillary
Item
other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational within 14 days before enrollment
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0949266 (UMLS CUI [4,1])
C1549485 (UMLS CUI [4,2])
HIV Seropositivity
Item
known to be hiv positive
boolean
C0019699 (UMLS CUI [1])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography
Item
myocardial infarction within 6 months prior to enrollment or has nyha class iii or iv hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C0151236 (UMLS CUI [6,1])
C1623258 (UMLS CUI [6,2])
Hypersensitivity Bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
hypersensitivity to bortezomib, boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0571922 (UMLS CUI [3])
Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical trial
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Live Vaccines Immunization Patient need for | Live Vaccines Immunization
Item
patients who may need or are receiving live vaccines for immunization
boolean
C0042211 (UMLS CUI [1,1])
C0020971 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0042211 (UMLS CUI [2,1])
C0020971 (UMLS CUI [2,2])
Tillbaka till toppen 

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