ID

21884

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00311337

Stichworte

Versionen (1)
  1. 06.05.17 06.05.17 -
Hochgeladen am

6. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00311337

Englisch

Eligibility Multiple Myeloma NCT00311337

1 Formulare  
Inclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

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

Contraceptive methods Agree

Datentyp

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
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient showing signs of disease progression
Beschreibung

Disease Progression Signs

Datentyp

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.
Beschreibung

Platelet Count measurement

Datentyp

boolean

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

Absolute neutrophil count

Datentyp

boolean

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

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

Datentyp

boolean

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

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
patient has hypersensitivity to bortezomib, boron, or mannitol.
Beschreibung

Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy

Datentyp

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
Beschreibung

bortezomib

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

Investigational New Drugs

Datentyp

boolean

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

Progressive Disease

Datentyp

boolean

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

Karnofsky Performance Status

Datentyp

boolean

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

Life Expectancy

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Study Subject Participation Status | Reagents Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0034760
UMLS CUI [2,2]
C1517586
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00311337

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