ID

31770

Beschreibung

Study of Vorinostat (MK0683), an HDAC Inhibitor, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (0683-095 AMJ); ODM derived from: https://clinicaltrials.gov/show/NCT00773838

Link

https://clinicaltrials.gov/show/NCT00773838

Stichworte

Versionen (1)
  1. 27.09.18 27.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Relapsed or Refractory Multiple Myeloma NCT00773838

Englisch

Eligibility Relapsed or Refractory Multiple Myeloma NCT00773838

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patient has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
patient must have adequate organ function
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
patient is refractory to prior bortezomib regimen and have also been exposed to prior imid (thalidimide or lenalidmide)
Beschreibung

Bortezomib refractory | Exposure to Imide | Exposure to Thalidomide | Exposure to Lenalidomide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1176309
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0020926
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0039736
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C1144149
patient has relapsed and refractory multiple myeloma after at lest 2 prior treatment regimens
Beschreibung

Relapse multiple myeloma | Refractory multiple myeloma | Status post Therapeutic procedure Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C2349261
UMLS CUI [2]
C0278620
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1265611
patient is relapsed, refractory, intolerant, and/or ineligible (in the opinion of the investigator) to other therapies including an imid (thalidomide or lenalidomide)
Beschreibung

Other Therapy Relapse | Other Therapy refractory | Intolerant Other Therapy | Ineligibility Other Therapy | Imide | Thalidomide | lenalidomide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0231200
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0205394
UMLS CUI [4,1]
C1512714
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0205394
UMLS CUI [5]
C0020926
UMLS CUI [6]
C0039736
UMLS CUI [7]
C1144149
patient is refractory to bortezomib (no response on prior bortezomib containing regimen or progression on or within 60 days of bortezomib containing regimen
Beschreibung

Bortezomib refractory | Therapeutic procedure Containing Bortezomib | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1176309
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C1176309
UMLS CUI [3]
C0242656
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has known hypersensitivity to any components of bortezomib or vorinostat
Beschreibung

Hypersensitivity Bortezomib Component | Hypersensitivity Vorinostat Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0672708
UMLS CUI [2,3]
C1705248
patient has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation within 4 weeks of the initiation of study therapy
Beschreibung

Allogeneic bone marrow transplantation | Bone Marrow Transplantation Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2,1]
C0005961
UMLS CUI [2,2]
C1301732
patient has known hypersensitivity to any components of bortezomib or vorinostat
Beschreibung

Hypersensitivity Bortezomib Component | Hypersensitivity Vorinostat Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0672708
UMLS CUI [2,3]
C1705248
patient has active hepatitis b or c, plasma cell leukemia, or is hiv positive
Beschreibung

Hepatitis B | Hepatitis C | Leukemia, Plasma Cell | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0023484
UMLS CUI [4]
C0019699
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Ähnliche Modelle

Eligibility Relapsed or Refractory Multiple Myeloma NCT00773838

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Multiple Myeloma
Item
patient has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria
boolean
C0026764 (UMLS CUI [1])
Organ function
Item
patient must have adequate organ function
boolean
C0678852 (UMLS CUI [1])
Bortezomib refractory | Exposure to Imide | Exposure to Thalidomide | Exposure to Lenalidomide
Item
patient is refractory to prior bortezomib regimen and have also been exposed to prior imid (thalidimide or lenalidmide)
boolean
C1176309 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0020926 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0039736 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C1144149 (UMLS CUI [4,2])
Relapse multiple myeloma | Refractory multiple myeloma | Status post Therapeutic procedure Quantity
Item
patient has relapsed and refractory multiple myeloma after at lest 2 prior treatment regimens
boolean
C2349261 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Other Therapy Relapse | Other Therapy refractory | Intolerant Other Therapy | Ineligibility Other Therapy | Imide | Thalidomide | lenalidomide
Item
patient is relapsed, refractory, intolerant, and/or ineligible (in the opinion of the investigator) to other therapies including an imid (thalidomide or lenalidomide)
boolean
C0087111 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0231200 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C1512714 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205394 (UMLS CUI [4,3])
C0020926 (UMLS CUI [5])
C0039736 (UMLS CUI [6])
C1144149 (UMLS CUI [7])
Bortezomib refractory | Therapeutic procedure Containing Bortezomib | Disease Progression
Item
patient is refractory to bortezomib (no response on prior bortezomib containing regimen or progression on or within 60 days of bortezomib containing regimen
boolean
C1176309 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C1176309 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Bortezomib Component | Hypersensitivity Vorinostat Component
Item
patient has known hypersensitivity to any components of bortezomib or vorinostat
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0672708 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Allogeneic bone marrow transplantation | Bone Marrow Transplantation Planned
Item
patient has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation within 4 weeks of the initiation of study therapy
boolean
C0149615 (UMLS CUI [1])
C0005961 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Hypersensitivity Bortezomib Component | Hypersensitivity Vorinostat Component
Item
patient has known hypersensitivity to any components of bortezomib or vorinostat
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0672708 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Hepatitis B | Hepatitis C | Leukemia, Plasma Cell | HIV Seropositivity
Item
patient has active hepatitis b or c, plasma cell leukemia, or is hiv positive
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0023484 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
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