ID

21893

Beschrijving

Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse; ODM derived from: https://clinicaltrials.gov/show/NCT00335348

Link

https://clinicaltrials.gov/show/NCT00335348

Trefwoorden

Versies (1)
  1. 06-05-17 06-05-17 -
Geüploaded op

6 mei 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00335348

Engels

Eligibility Multiple Myeloma NCT00335348

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or *third line therapy because of pd, defined as a 25% increase in m-protein, or development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dl), or relapse from cr.*patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies.
Beschrijving

Multiple Myeloma | Progressive Disease | Second line treatment Patient need for | Third line treatment Patient need for | M Protein Percentage Increased | Lytic lesion New | Lytic lesion Worsening | malignant plasmacytoma of soft tissue | Hypercalcemia | Serum calcium measurement | In complete remission Relapse | bortezomib | Dexamethasone | Thalidomide | Adrenal Cortex Hormones | Revlimid

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C1710038
UMLS CUI [3,2]
C0686904
UMLS CUI [4,1]
C2986605
UMLS CUI [4,2]
C0686904
UMLS CUI [5,1]
C0700271
UMLS CUI [5,2]
C0439165
UMLS CUI [5,3]
C0205217
UMLS CUI [6,1]
C0221204
UMLS CUI [6,2]
C0205314
UMLS CUI [7,1]
C0221204
UMLS CUI [7,2]
C0332271
UMLS CUI [8]
C2211566
UMLS CUI [9]
C0020437
UMLS CUI [10]
C0728876
UMLS CUI [11,1]
C0677874
UMLS CUI [11,2]
C0035020
UMLS CUI [12]
C1176309
UMLS CUI [13]
C0011777
UMLS CUI [14]
C0039736
UMLS CUI [15]
C0001617
UMLS CUI [16]
C1135145
patient is of a legally consenting age, as defined by local regulations.
Beschrijving

Age Legal consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0814676
patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Beschrijving

Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0036899
male patient agrees to use an acceptable method for contraception for the duration of the study.
Beschrijving

Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
patient has measurable disease
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
patient has a karnofsky performance status ≥60%.
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
patient has a life-expectancy >3 months.
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary dexamethasone resistance
Beschrijving

Resistance Primary Dexamethasone

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514892
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0011777
prior therapy with bortezomib
Beschrijving

bortezomib

Datatype

boolean

Alias
UMLS CUI [1]
C1176309
prior severe allergic reactions to bortezomib (velcade), boron or mannitol
Beschrijving

Allergic Reaction Severe bortezomib | Allergic Reaction Severe Velcade | Allergic Reaction Severe Boron | Mannitol allergy Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1176309
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1174739
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0006030
UMLS CUI [4,1]
C0571922
UMLS CUI [4,2]
C0205082
neuropathy > grade 2 with pain by nci-ctcae criteria
Beschrijving

Painful Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C1850383
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility Multiple Myeloma NCT00335348

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Progressive Disease | Second line treatment Patient need for | Third line treatment Patient need for | M Protein Percentage Increased | Lytic lesion New | Lytic lesion Worsening | malignant plasmacytoma of soft tissue | Hypercalcemia | Serum calcium measurement | In complete remission Relapse | bortezomib | Dexamethasone | Thalidomide | Adrenal Cortex Hormones | Revlimid
Item
patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or *third line therapy because of pd, defined as a 25% increase in m-protein, or development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dl), or relapse from cr.*patients will only be eligible for bortezomib as 3rd line therapy if they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or revlimid alone (or with corticosteroids) as one of the 2 prior therapies.
boolean
C0026764 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C1710038 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
C2986605 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
C0700271 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C0205217 (UMLS CUI [5,3])
C0221204 (UMLS CUI [6,1])
C0205314 (UMLS CUI [6,2])
C0221204 (UMLS CUI [7,1])
C0332271 (UMLS CUI [7,2])
C2211566 (UMLS CUI [8])
C0020437 (UMLS CUI [9])
C0728876 (UMLS CUI [10])
C0677874 (UMLS CUI [11,1])
C0035020 (UMLS CUI [11,2])
C1176309 (UMLS CUI [12])
C0011777 (UMLS CUI [13])
C0039736 (UMLS CUI [14])
C0001617 (UMLS CUI [15])
C1135145 (UMLS CUI [16])
Age Legal consent
Item
patient is of a legally consenting age, as defined by local regulations.
boolean
C0001779 (UMLS CUI [1,1])
C0814676 (UMLS CUI [1,2])
Protocol Compliance
Item
patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence
Item
female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
Gender Contraceptive methods
Item
male patient agrees to use an acceptable method for contraception for the duration of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Measurable Disease
Item
patient has measurable disease
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
patient has a karnofsky performance status ≥60%.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
patient has a life-expectancy >3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Resistance Primary Dexamethasone
Item
primary dexamethasone resistance
boolean
C1514892 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0011777 (UMLS CUI [1,3])
bortezomib
Item
prior therapy with bortezomib
boolean
C1176309 (UMLS CUI [1])
Allergic Reaction Severe bortezomib | Allergic Reaction Severe Velcade | Allergic Reaction Severe Boron | Mannitol allergy Severe
Item
prior severe allergic reactions to bortezomib (velcade), boron or mannitol
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1176309 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1174739 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0006030 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Painful Neuropathy CTCAE Grades
Item
neuropathy > grade 2 with pain by nci-ctcae criteria
boolean
C1850383 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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