ID

30920

Description

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

Keywords

Versions (1)
  1. 7/3/18 7/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01207765

English

Eligibility Multiple Myeloma NCT01207765

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Multiple Myeloma

Data type

boolean

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

Disease Durie/Salmon Stage

Data type

boolean

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

Measurable Disease Serum | Measurable Disease In Urine

Data type

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
Description

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

Data type

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.
Description

Elapsed Time Since Autologous hematopoietic stem cell transplant

Data type

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.
Description

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

Data type

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 ≥
Description

Hematologic function | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

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

ID.8

Data type

boolean

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

Serum direct bilirubin measurement | Transaminase Assay

Data type

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).
Description

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

Data type

boolean

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

Exclusion Criteria

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

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

Data type

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
Description

Non-secretory myeloma

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

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
Description

Contraceptive methods Unwilling

Data type

boolean

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

Communicable Disease

Data type

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
Description

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

Data type

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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Similar models

Eligibility Multiple Myeloma NCT01207765

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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