ID

31766

Beschreibung

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

Stichworte

Versionen (1)
  1. 26.09.18 26.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. September 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Relapsed or Refractory Multiple Myeloma NCT00642954

Englisch

Eligibility Relapsed or Refractory Multiple Myeloma NCT00642954

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Relapse multiple myeloma | Refractory multiple myeloma | Prior Therapy Quantity

Datentyp

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
Beschreibung

Childbearing Potential Serum pregnancy test negative Quantity

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Gender Contraceptive methods | Vasectomy Successful

Datentyp

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
Beschreibung

Gender Use of Latex condom

Datentyp

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
Beschreibung

Washout Period Duration

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Histone deacetylase inhibitor

Datentyp

boolean

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

Allogeneic bone marrow transplantation

Datentyp

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
Beschreibung

Antibiotics Intravenous | Antiviral Agents Intravenous | Antifungal Agents Intravenous

Datentyp

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
Beschreibung

Illicit medication use | Substance Use Disorders

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding | Pregnancy Expected

Datentyp

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
Beschreibung

HIV Infection

Datentyp

boolean

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

Hepatitis B | Hepatitis C

Datentyp

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
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Relapsed or Refractory Multiple Myeloma NCT00642954

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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