ID

30920

Beschreibung

Fixed Dose Radioimmunotherapy (Zevalin) for Patients With Incomplete Response to Chemo Prior to Autologous Stem Cell Transplant for Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01207765

Link

https://clinicaltrials.gov/show/NCT01207765

Stichworte

Versionen (1)
  1. 03.07.18 03.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Juli 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01207765

Englisch

Eligibility Multiple Myeloma NCT01207765

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet established criteria for the diagnosis of multiple myeloma
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
durie-salmon stage ii or iii disease
Beschreibung

Disease Durie/Salmon Stage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4528204
measurable disease in the serum and/or urine
Beschreibung

Measurable Disease Serum | Measurable Disease In Urine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0229671
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0042037
scheduled to receive high dose chemotherapy and autologous stem cell transplant for multiple myeloma
Beschreibung

High-dose chemotherapy Scheduled Multiple Myeloma | Autologous hematopoietic stem cell transplant Scheduled Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1328050
UMLS CUI [1,2]
C0205539
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C2193200
UMLS CUI [2,2]
C0205539
UMLS CUI [2,3]
C0026764
individuals who have previously undergone autologous stem cell transplant are eligible for this study provided more than 6 months have elapsed from the prior transplant.
Beschreibung

Elapsed Time Since Autologous hematopoietic stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C2193200
minimum stem cell dose of 4x106 cd34+ mnc / kg stored for autologous stem cell rescue.
Beschreibung

Stem cells Dose CD34 positive | Stem cells Storage Minimum Autologous Stem Cell Rescue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038250
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0882849
UMLS CUI [2,1]
C0038250
UMLS CUI [2,2]
C1698986
UMLS CUI [2,3]
C1524031
UMLS CUI [2,4]
C2825926
adequate hematologic reserve as evidenced by anc ≥ 1500/mm3 and platelets ≥
Beschreibung

Hematologic function | Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
100,000/mm3.
Beschreibung

ID.8

Datentyp

boolean

serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 3x institution upper limit of normal.
Beschreibung

Serum direct bilirubin measurement | Transaminase Assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1883011
UMLS CUI [2]
C0919834
serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min (either calculated or measured).
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
UMLS CUI [3]
C0373595
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage i or smoldering myeloma, isolated plasmacytoma, or benign monoclonal gammopathy
Beschreibung

Multiple Myeloma Durie/Salmon Stage | Smoldering myeloma | Plasmacytoma Isolated | Monoclonal Gammopathy Benign

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C4528204
UMLS CUI [2]
C1531608
UMLS CUI [3,1]
C0032131
UMLS CUI [3,2]
C0205409
UMLS CUI [4,1]
C1136085
UMLS CUI [4,2]
C0205183
non-secretory multiple myeloma
Beschreibung

Non-secretory myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0456845
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
males and females who do not agree to practice approved methods of birth control for the duration of the study
Beschreibung

Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
presence of active infection
Beschreibung

Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
receipt of previous radiation therapy to critical organs exceeding any of the following limits: kidney 500 cgy, liver 1000 cgy, lungs 500 cgy
Beschreibung

Prior radiation therapy Organ Critical | Kidney Greater Than cGy Quantity | Liver Greater Than cGy Quantity | Lung Greater Than cGy Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C1511545
UMLS CUI [2,1]
C0022646
UMLS CUI [2,2]
C0439093
UMLS CUI [2,3]
C0556645
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C0023884
UMLS CUI [3,2]
C0439093
UMLS CUI [3,3]
C0556645
UMLS CUI [3,4]
C1265611
UMLS CUI [4,1]
C0024109
UMLS CUI [4,2]
C0439093
UMLS CUI [4,3]
C0556645
UMLS CUI [4,4]
C1265611
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT01207765

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
meet established criteria for the diagnosis of multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Disease Durie/Salmon Stage
Item
durie-salmon stage ii or iii disease
boolean
C0012634 (UMLS CUI [1,1])
C4528204 (UMLS CUI [1,2])
Measurable Disease Serum | Measurable Disease In Urine
Item
measurable disease in the serum and/or urine
boolean
C1513041 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0042037 (UMLS CUI [2,2])
High-dose chemotherapy Scheduled Multiple Myeloma | Autologous hematopoietic stem cell transplant Scheduled Multiple Myeloma
Item
scheduled to receive high dose chemotherapy and autologous stem cell transplant for multiple myeloma
boolean
C1328050 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C2193200 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Elapsed Time Since Autologous hematopoietic stem cell transplant
Item
individuals who have previously undergone autologous stem cell transplant are eligible for this study provided more than 6 months have elapsed from the prior transplant.
boolean
C2826303 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C2193200 (UMLS CUI [1,3])
Stem cells Dose CD34 positive | Stem cells Storage Minimum Autologous Stem Cell Rescue
Item
minimum stem cell dose of 4x106 cd34+ mnc / kg stored for autologous stem cell rescue.
boolean
C0038250 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0882849 (UMLS CUI [1,3])
C0038250 (UMLS CUI [2,1])
C1698986 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
C2825926 (UMLS CUI [2,4])
Hematologic function | Absolute neutrophil count | Platelet Count measurement
Item
adequate hematologic reserve as evidenced by anc ≥ 1500/mm3 and platelets ≥
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
ID.8
Item
100,000/mm3.
boolean
Serum direct bilirubin measurement | Transaminase Assay
Item
serum direct bilirubin ≤ 2.0 mg/dl and transaminases ≤ 3x institution upper limit of normal.
boolean
C1883011 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
serum creatinine ≤ 2 mg/dl with creatinine clearance ≥ 60 ml/min (either calculated or measured).
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Multiple Myeloma Durie/Salmon Stage | Smoldering myeloma | Plasmacytoma Isolated | Monoclonal Gammopathy Benign
Item
stage i or smoldering myeloma, isolated plasmacytoma, or benign monoclonal gammopathy
boolean
C0026764 (UMLS CUI [1,1])
C4528204 (UMLS CUI [1,2])
C1531608 (UMLS CUI [2])
C0032131 (UMLS CUI [3,1])
C0205409 (UMLS CUI [3,2])
C1136085 (UMLS CUI [4,1])
C0205183 (UMLS CUI [4,2])
Non-secretory myeloma
Item
non-secretory multiple myeloma
boolean
C0456845 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling
Item
males and females who do not agree to practice approved methods of birth control for the duration of the study
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Communicable Disease
Item
presence of active infection
boolean
C0009450 (UMLS CUI [1])
Prior radiation therapy Organ Critical | Kidney Greater Than cGy Quantity | Liver Greater Than cGy Quantity | Lung Greater Than cGy Quantity
Item
receipt of previous radiation therapy to critical organs exceeding any of the following limits: kidney 500 cgy, liver 1000 cgy, lungs 500 cgy
boolean
C0279134 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C1511545 (UMLS CUI [1,3])
C0022646 (UMLS CUI [2,1])
C0439093 (UMLS CUI [2,2])
C0556645 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0023884 (UMLS CUI [3,1])
C0439093 (UMLS CUI [3,2])
C0556645 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
C0024109 (UMLS CUI [4,1])
C0439093 (UMLS CUI [4,2])
C0556645 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Zum Seitenanfang zurückkehren 

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