ID

31761

Description

Ph II of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG; ODM derived from: https://clinicaltrials.gov/show/NCT00899847

Link

https://clinicaltrials.gov/show/NCT00899847

Keywords

Versions (1)
  1. 9/26/18 9/26/18 -
Copyright Holder

Wen-Kai Weng, Stanford University

Uploaded on

September 26, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Transplantation, Homologous, multiple myeloma and plasma cell leukemia NCT00899847

English

Eligibility Transplantation, Homologous, multiple myeloma and plasma cell leukemia NCT00899847

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage ii-iii multiple myeloma or have progression after initial treatment of stage i disease (durie salmon staging). patients with plasma cell leukemia are also included. pathology reviewed and the diagnosis confirmed at stanford university medical center.
Description

Multiple myeloma (stage ii-iii )/ progressed, plasma cell leukemia; pathology report

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C4528204
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0242656
UMLS CUI [2,3]
C0231290
UMLS CUI [2,4]
C0087111
UMLS CUI [3]
C0023484
UMLS CUI [4]
C0807321
age > 18 years and <= 75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky performance status > 70%.
Description

Karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
corrected dlco > 60%
Description

Carbon monoxide diffusing capacity

Data type

boolean

Alias
UMLS CUI [1]
C1516251
left ventricle ejection fraction (lvef) > 50%.
Description

Left ventricle ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
alt and ast must be <= 2x normal. total bilirubin <= 2 mg/dl unless hemolysis or gilbert's disease.
Description

ALT, AST, total bilirubin (except hemolysis and gilbert's disease)

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201913
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0019054
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0017551
estimated creatinine clearance > 50 ml/min.
Description

Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
have a related or unrelated hla-identical donor or one antigen/allele mismatched in hla-a, b, c or drb1.
Description

Hla-identical donor/one antigen/allele mismatched in hla-a, b, c or drb1

Data type

boolean

Alias
UMLS CUI [1,1]
C0019721
UMLS CUI [1,2]
C0205280
UMLS CUI [1,3]
C0013018
UMLS CUI [2,1]
C0019728
UMLS CUI [2,2]
C1881865
UMLS CUI [3,1]
C0019737
UMLS CUI [3,2]
C1881865
UMLS CUI [4,1]
C0019751
UMLS CUI [4,2]
C1881865
UMLS CUI [5,1]
C0122040
UMLS CUI [5,2]
C1881865
signed informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Inclusion criteria for donor
Description

Inclusion criteria for donor

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0013018
age >=17.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hiv seronegative
Description

HIV seronegative

Data type

boolean

Alias
UMLS CUI [1]
C0019698
donor must be capable of giving signed, informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
no contraindication to the administration of g-csf
Description

No contraindication filgrastim

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0522473
UMLS CUI [1,3]
C0210630
willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate.
Description

Willing to have a central venous catheter

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C1145640
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior allogeneic hematopoietic cell transplantation.
Description

Prior allogeneic hematopoietic cell transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1705576
UMLS CUI [1,2]
C0332152
uncontrolled active infection.
Description

Uncontrolled active infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
uncontrolled congestive heart failure or angina.
Description

Uncontrolled congestive heart failure/angina

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0002962
pregnancy or nursing patients will be excluded from the study.
Description

Pregnancy/breast feeding patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
those who are hiv-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.
Description

Hiv positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
donor evaluation exclusion criteria
Description

donor evaluation exclusion criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0013018
serious medical or psychological illness.
Description

Serious medical/psychological illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0205082
UMLS CUI [1,2]
C0262926
UMLS CUI [2]
C0004936
pregnant or lactating women are not eligible
Description

Pregnancy, lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
prior malignancies within the last 5 years except for non-melanoma skin cancers
Description

Prior malignancies (except for non-melanoma skin cancers)

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0677898
UMLS CUI [1,5]
C0699893
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Similar models

Eligibility Transplantation, Homologous, multiple myeloma and plasma cell leukemia NCT00899847

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple myeloma (stage ii-iii )/ progressed, plasma cell leukemia; pathology report
Item
stage ii-iii multiple myeloma or have progression after initial treatment of stage i disease (durie salmon staging). patients with plasma cell leukemia are also included. pathology reviewed and the diagnosis confirmed at stanford university medical center.
boolean
C0026764 (UMLS CUI [1,1])
C4528204 (UMLS CUI [1,2])
C0026764 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
C0231290 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0023484 (UMLS CUI [3])
C0807321 (UMLS CUI [4])
Age
Item
age > 18 years and <= 75 years.
boolean
C0001779 (UMLS CUI [1])
Karnofsky performance status
Item
karnofsky performance status > 70%.
boolean
C0206065 (UMLS CUI [1])
Carbon monoxide diffusing capacity
Item
corrected dlco > 60%
boolean
C1516251 (UMLS CUI [1])
Left ventricle ejection fraction
Item
left ventricle ejection fraction (lvef) > 50%.
boolean
C0428772 (UMLS CUI [1])
ALT, AST, total bilirubin (except hemolysis and gilbert's disease)
Item
alt and ast must be <= 2x normal. total bilirubin <= 2 mg/dl unless hemolysis or gilbert's disease.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0332300 (UMLS CUI [4,1])
C0019054 (UMLS CUI [4,2])
C0332300 (UMLS CUI [5,1])
C0017551 (UMLS CUI [5,2])
Creatinine clearance
Item
estimated creatinine clearance > 50 ml/min.
boolean
C0373595 (UMLS CUI [1])
Hla-identical donor/one antigen/allele mismatched in hla-a, b, c or drb1
Item
have a related or unrelated hla-identical donor or one antigen/allele mismatched in hla-a, b, c or drb1.
boolean
C0019721 (UMLS CUI [1,1])
C0205280 (UMLS CUI [1,2])
C0013018 (UMLS CUI [1,3])
C0019728 (UMLS CUI [2,1])
C1881865 (UMLS CUI [2,2])
C0019737 (UMLS CUI [3,1])
C1881865 (UMLS CUI [3,2])
C0019751 (UMLS CUI [4,1])
C1881865 (UMLS CUI [4,2])
C0122040 (UMLS CUI [5,1])
C1881865 (UMLS CUI [5,2])
Informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
Inclusion criteria for donor
C1512693 (UMLS CUI-1)
C0013018 (UMLS CUI-2)
Age
Item
age >=17.
boolean
C0001779 (UMLS CUI [1])
HIV seronegative
Item
hiv seronegative
boolean
C0019698 (UMLS CUI [1])
Informed consent
Item
donor must be capable of giving signed, informed consent
boolean
C0021430 (UMLS CUI [1])
No contraindication filgrastim
Item
no contraindication to the administration of g-csf
boolean
C1298908 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
C0210630 (UMLS CUI [1,3])
Willing to have a central venous catheter
Item
willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate.
boolean
C0600109 (UMLS CUI [1,1])
C1145640 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior allogeneic hematopoietic cell transplantation
Item
prior allogeneic hematopoietic cell transplantation.
boolean
C1705576 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Uncontrolled active infection
Item
uncontrolled active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Uncontrolled congestive heart failure/angina
Item
uncontrolled congestive heart failure or angina.
boolean
C0018802 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2])
Pregnancy/breast feeding patients
Item
pregnancy or nursing patients will be excluded from the study.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Hiv positive
Item
those who are hiv-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation.
boolean
C0019699 (UMLS CUI [1])
Item Group
donor evaluation exclusion criteria
C0680251 (UMLS CUI-1)
C0013018 (UMLS CUI-2)
Serious medical/psychological illness
Item
serious medical or psychological illness.
boolean
C0205082 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
Pregnancy, lactating
Item
pregnant or lactating women are not eligible
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Prior malignancies (except for non-melanoma skin cancers)
Item
prior malignancies within the last 5 years except for non-melanoma skin cancers
boolean
C0006826 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0677898 (UMLS CUI [1,4])
C0699893 (UMLS CUI [1,5])
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