ID

21884

Beskrivning

VELCADE as Maintenance Treatment in Patients With Multiple Myeloma Following Autologous Peripheral Blood Stem Cell Transplantation (PBSCT); ODM derived from: https://clinicaltrials.gov/show/NCT00311337

Länk

https://clinicaltrials.gov/show/NCT00311337

Nyckelord

Versioner (1)
  1. 2017-05-06 2017-05-06 -
Uppladdad den

6 maj 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Multiple Myeloma NCT00311337

Engelsk

Eligibility Multiple Myeloma NCT00311337

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient having received tandem transplants with high-dose melphalan and autologous pbsct within 3-6 months prior to inclusion into this protocol
Beskrivning

Tandem Transplantation | Melphalan High dose | Autologous peripheral blood stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C3897372
UMLS CUI [2,1]
C0025241
UMLS CUI [2,2]
C0444956
UMLS CUI [3]
C1960579
patients with measurable minimal residual disease (very good partial remission [vgpr]) or patients in partial remission (pr) or patients with stable disease (sd) at the time of inclusion in the study
Beskrivning

Measurable Disease Residual Minimal | Very Good Partial Response | partial response | Stable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1609982
UMLS CUI [1,3]
C0547040
UMLS CUI [2]
C4053871
UMLS CUI [3]
C1521726
UMLS CUI [4]
C0677946
patient must agree to participate in the study.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patient agrees to use an appropriate method of contraception.
Beskrivning

Contraceptive methods Agree

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641827
willingness and ability to comply with the study protocol for the duration of the study
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient showing signs of disease progression
Beskrivning

Disease Progression Signs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0311392
patient has a platelet count < 100 x 10^9/l within 14 days before enrollment.
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
patient has an absolute neutrophil count < 1.0 x 10^9/l within 14 days before enrollment.
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
patient has a calculated or measured creatinine clearance < 30 ml/minute within 14 days before enrollment.
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0373595
patient has >= grade 2 peripheral neuropathy within 14 days before enrollment.
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
patient has 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
patient has received prior treatment with bortezomib
Beskrivning

bortezomib

Datatyp

boolean

Alias
UMLS CUI [1]
C1176309
patient is pregnant or nursing
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient has received other investigational drugs within 14 days before enrollment
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patient has progressive disease
Beskrivning

Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
patient has a karnofsky performance status < 60%
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
patient has a life expectancy of < 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids
Beskrivning

Pharmaceutical Preparations Disease Modification | Transplantation of autologous hematopoietic stem cell | aminobisphosphonate | Interferon-alpha | Glucocorticoids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0392747
UMLS CUI [2]
C1831743
UMLS CUI [3]
C2091830
UMLS CUI [4]
C0002199
UMLS CUI [5]
C0017710
patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.
Beskrivning

Study Subject Participation Status | Reagents Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0034760
UMLS CUI [2,2]
C1517586
Tillbaka till toppen

Similar models

Eligibility Multiple Myeloma NCT00311337

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Tandem Transplantation | Melphalan High dose | Autologous peripheral blood stem cell transplant
Item
patient having received tandem transplants with high-dose melphalan and autologous pbsct within 3-6 months prior to inclusion into this protocol
boolean
C3897372 (UMLS CUI [1])
C0025241 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C1960579 (UMLS CUI [3])
Measurable Disease Residual Minimal | Very Good Partial Response | partial response | Stable Disease
Item
patients with measurable minimal residual disease (very good partial remission [vgpr]) or patients in partial remission (pr) or patients with stable disease (sd) at the time of inclusion in the study
boolean
C1513041 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C4053871 (UMLS CUI [2])
C1521726 (UMLS CUI [3])
C0677946 (UMLS CUI [4])
Informed Consent
Item
patient must agree to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods Agree
Item
patient agrees to use an appropriate method of contraception.
boolean
C0700589 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Protocol Compliance
Item
willingness and ability to comply with the study protocol for the duration of the study
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease Progression Signs
Item
patient showing signs of disease progression
boolean
C0242656 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
Platelet Count measurement
Item
patient has a platelet count < 100 x 10^9/l within 14 days before enrollment.
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
patient has an absolute neutrophil count < 1.0 x 10^9/l within 14 days before enrollment.
boolean
C0948762 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
patient has a calculated or measured creatinine clearance < 30 ml/minute within 14 days before enrollment.
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
patient has >= grade 2 peripheral neuropathy within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy
Item
patient has 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])
bortezomib
Item
patient has received prior treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patient is pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patient has received other investigational drugs within 14 days before enrollment
boolean
C0013230 (UMLS CUI [1])
Progressive Disease
Item
patient has progressive disease
boolean
C1335499 (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 of < 3 months
boolean
C0023671 (UMLS CUI [1])
Pharmaceutical Preparations Disease Modification | Transplantation of autologous hematopoietic stem cell | aminobisphosphonate | Interferon-alpha | Glucocorticoids
Item
patient has received disease modifying agents following autologous stem cell transplantation other than aminobisphosphonates such as interferon-alpha or glucocorticosteroids
boolean
C0013227 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1831743 (UMLS CUI [2])
C2091830 (UMLS CUI [3])
C0002199 (UMLS CUI [4])
C0017710 (UMLS CUI [5])
Study Subject Participation Status | Reagents Investigational
Item
patient currently enrolled in another clinical research study and/or receiving an investigational reagent for any reason.
boolean
C2348568 (UMLS CUI [1])
C0034760 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial