ID

31766

Descrição

Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074); ODM derived from: https://clinicaltrials.gov/show/NCT00642954

Link

https://clinicaltrials.gov/show/NCT00642954

Palavras-chave

Versões (1)
  1. 26/09/2018 26/09/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de setembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Relapsed or Refractory Multiple Myeloma NCT00642954

Inglês

Eligibility Relapsed or Refractory Multiple Myeloma NCT00642954

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is a male or female at least 18 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient has relapsed or refractory mm and has had at least one prior therapy
Descrição

Relapse multiple myeloma | Refractory multiple myeloma | Prior Therapy Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2349261
UMLS CUI [2]
C0278620
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1265611
female patients of childbearing potential must have 2 negative serum pregnancy tests prior to receiving the first dose of study drugs
Descrição

Childbearing Potential Serum pregnancy test negative Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [1,3]
C1265611
female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping lenalidomide. post menopausal patients should be free from menses for > 2 years, or are surgically sterilized
Descrição

Childbearing Potential Contraceptive methods Quantity | Lenalidomide Discontinued | Postmenopausal state | Female Sterilization

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1144149
UMLS CUI [2,2]
C1444662
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
male patient agrees to use an adequate method of contraception for the duration of the study, even if the patient has undergone a successful vasectomy
Descrição

Gender Contraceptive methods | Vasectomy Successful

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0042387
UMLS CUI [2,2]
C1272703
male patients must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant. this is required for the duration of the study, and for 4 weeks after stopping therapy
Descrição

Gender Use of Latex condom

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C3873750
patient has at least 3 weeks washout prior to treatment
Descrição

Washout Period Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1710661
UMLS CUI [1,2]
C0449238
patient is able to swallow capsules and is able to take or tolerate oral medications on a continuous basis
Descrição

Able to swallow capsules | Ability Intake Oral medication | Ability Receive Oral medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C0175795
UMLS CUI [3,1]
C0085732
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C0175795
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has prior treatment with an histone deacetylase (hdac) inhibitor
Descrição

Histone deacetylase inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1512474
patient has prior allogenetic bone marrow transplant
Descrição

Allogeneic bone marrow transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149615
patient has received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug
Descrição

Antibiotics Intravenous | Antiviral Agents Intravenous | Antifungal Agents Intravenous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1522726
UMLS CUI [2,1]
C0003451
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C0003308
UMLS CUI [3,2]
C1522726
patient uses illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
Descrição

Illicit medication use | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2]
C0038586
patient is pregnant or breast feeding or expecting to have a baby during the course of the study
Descrição

Pregnancy | Breast Feeding | Pregnancy Expected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1517001
patient has human immunodeficiency virus (hiv) infection
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
patient has hepatitis b/c infection
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
patient is currently receiving treatment for another type of cancer other than skin or cervical cancer that has not been in remission for 5 years or longer
Descrição

Therapeutic procedure Cancer Other | Exception Skin carcinoma | Exception Cervix carcinoma | Cancer Remission Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0302592
UMLS CUI [4,1]
C0687702
UMLS CUI [4,2]
C0332197
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Similar models

Eligibility Relapsed or Refractory Multiple Myeloma NCT00642954

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is a male or female at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Relapse multiple myeloma | Refractory multiple myeloma | Prior Therapy Quantity
Item
patient has relapsed or refractory mm and has had at least one prior therapy
boolean
C2349261 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test negative Quantity
Item
female patients of childbearing potential must have 2 negative serum pregnancy tests prior to receiving the first dose of study drugs
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods Quantity | Lenalidomide Discontinued | Postmenopausal state | Female Sterilization
Item
female patients who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping lenalidomide. post menopausal patients should be free from menses for > 2 years, or are surgically sterilized
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1144149 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Gender Contraceptive methods | Vasectomy Successful
Item
male patient agrees to use an adequate method of contraception for the duration of the study, even if the patient has undergone a successful vasectomy
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0042387 (UMLS CUI [2,1])
C1272703 (UMLS CUI [2,2])
Gender Use of Latex condom
Item
male patients must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant. this is required for the duration of the study, and for 4 weeks after stopping therapy
boolean
C0079399 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C3873750 (UMLS CUI [1,3])
Washout Period Duration
Item
patient has at least 3 weeks washout prior to treatment
boolean
C1710661 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Able to swallow capsules | Ability Intake Oral medication | Ability Receive Oral medication
Item
patient is able to swallow capsules and is able to take or tolerate oral medications on a continuous basis
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
C0085732 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0175795 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Histone deacetylase inhibitor
Item
patient has prior treatment with an histone deacetylase (hdac) inhibitor
boolean
C1512474 (UMLS CUI [1])
Allogeneic bone marrow transplantation
Item
patient has prior allogenetic bone marrow transplant
boolean
C0149615 (UMLS CUI [1])
Antibiotics Intravenous | Antiviral Agents Intravenous | Antifungal Agents Intravenous
Item
patient has received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug
boolean
C0003232 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0003451 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0003308 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Illicit medication use | Substance Use Disorders
Item
patient uses illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
boolean
C0281875 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy Expected
Item
patient is pregnant or breast feeding or expecting to have a baby during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
HIV Infection
Item
patient has human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
patient has hepatitis b/c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Therapeutic procedure Cancer Other | Exception Skin carcinoma | Exception Cervix carcinoma | Cancer Remission Absent
Item
patient is currently receiving treatment for another type of cancer other than skin or cervical cancer that has not been in remission for 5 years or longer
boolean
C0087111 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0302592 (UMLS CUI [3,2])
C0687702 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
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