ID

18176

Description

Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00089453

Link

https://clinicaltrials.gov/show/NCT00089453

Keywords

Versions (1)
  1. 10/24/16 10/24/16 -
Uploaded on

October 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00089453

English

Eligibility Multiple Myeloma NCT00089453

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
mm in frank relapse after a single or tandem transplant or high risk myeloma
Description

Multiple Myeloma | Recurrent disease Post Transplantation | Multiple Myeloma High risk

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0040732
UMLS CUI [3,1]
C0026764
UMLS CUI [3,2]
C0332167
patients with prior transplant must be more than 4 months after the last transplant
Description

Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0040732
karnofsky performance score >or =70, or a performance score of 50-70 exclusively due to bone pain caused by myeloma
Description

Karnofsky Performance Status | Karnofsky Performance Status Due to Bone pain caused by Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2,1]
C0206065
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0151825
UMLS CUI [2,4]
C0015127
UMLS CUI [2,5]
C0026764
18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
an expected survival greater than 3 months
Description

Continuance of life Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0038952
UMLS CUI [1,2]
C1517001
anc >1,000/microliters, platelet count > 100,000/microliters
Description

Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
donor and patient must have signed an irb-approved consent and been informed about the investigational nature of the study
Description

Informed Consent | Informed Consent Donor

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0040288
donor must have negative serology for hiv
Description

Donor HIV Serology negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C0019682
UMLS CUI [1,3]
C0919674
available haplo-identical family donor fit to undergo leukapheresis and mismatched for kir-ligand(s) with the patient in the graft-versus host direction.
Description

Donor Relative Haploidentical | Donor Appropriate Leukapheresis | Donor Mismatch KIR Ligand Patient Graft vs Host Reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C0080103
UMLS CUI [1,3]
C3829897
UMLS CUI [2,1]
C0040288
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0023416
UMLS CUI [3,1]
C0040288
UMLS CUI [3,2]
C1881865
UMLS CUI [3,3]
C3642144
UMLS CUI [3,4]
C0030705
UMLS CUI [3,5]
C0018134
stored cells for autografting of at least 30 million cd34+ cells/kg
Description

Cell storage CD34+ cell Autografting

Data type

boolean

Alias
UMLS CUI [1,1]
C2025607
UMLS CUI [1,2]
C0882849
UMLS CUI [1,3]
C0040736
back-up cells of at least 20 million cd34+ cells/kg in case of non-engraftment.
Description

Cell storage CD34+ cell Engraft failure

Data type

boolean

Alias
UMLS CUI [1,1]
C2025607
UMLS CUI [1,2]
C0882849
UMLS CUI [1,3]
C2242642
there must be an unambiguous marker for response to therapy in the first ten patients. therefore the patient must have detectable and quantifiable m-protein or light chain excretion in urine, light chain quantification in serum (freelite) or clear radiological signal lesion(s) in order to be eligible
Description

Disease Response | M Protein In Urine | Urine light chain measurement | Serum Free Immunoglobulin Light Chain

Data type

boolean

Alias
UMLS CUI [1]
C1704632
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0042037
UMLS CUI [3]
C1445962
UMLS CUI [4]
C2827352
after 10 relapsed patients have been treated and toxicity is deemed acceptable, high-risk myeloma (defined as the presence of abnormal cytogenetics or metaphase analysis) patients without relapse can be entered
Description

Recurrent disease | Toxic effect Acceptable | Multiple Myeloma High risk | Cytogenetic abnormalities | Metaphase Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1879533
UMLS CUI [3,1]
C0026764
UMLS CUI [3,2]
C0332167
UMLS CUI [4]
C0008625
UMLS CUI [5,1]
C1621812
UMLS CUI [5,2]
C0205161
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
intravenous chemotherapy or antibody therapy affecting t-lymphocytes and/or natural killer cells e.g. cyclophosphamide, melphalan, atg, campath-1h etc. within the past 2 weeks prior to commencement of conditioning. last therapy is less than 14 days prior to starting fludarabine
Description

Intravenous chemotherapy Affecting T-Lymphocyte | antibody therapy Intravenous Affecting T-Lymphocyte | Intravenous chemotherapy Affecting Natural Killer Cells | antibody therapy Intravenous Affecting Natural Killer Cells | Cyclophosphamide | Melphalan | Anti-Thymocyte Globulin | Campath 1H | fludarabine

Data type

boolean

Alias
UMLS CUI [1,1]
C0413365
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0039194
UMLS CUI [2,1]
C0281176
UMLS CUI [2,2]
C1522726
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0039194
UMLS CUI [3,1]
C0413365
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0022688
UMLS CUI [4,1]
C0281176
UMLS CUI [4,2]
C1522726
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0022688
UMLS CUI [5]
C0010583
UMLS CUI [6]
C0025241
UMLS CUI [7]
C0003442
UMLS CUI [8]
C1178562
UMLS CUI [9]
C0059985
fever or active infection, requiring iv antibiotics
Description

Fever | Communicable Disease Requirement Intravenous antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0559680
liver function: total bilirubin > 2xuln or ast/alt >3xuln
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
renal function: patients on dialysis
Description

Renal function | Dialysis procedure

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0011946
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Similar models

Eligibility Multiple Myeloma NCT00089453

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Recurrent disease Post Transplantation | Multiple Myeloma High risk
Item
mm in frank relapse after a single or tandem transplant or high risk myeloma
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
C0026764 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
Transplantation
Item
patients with prior transplant must be more than 4 months after the last transplant
boolean
C0040732 (UMLS CUI [1])
Karnofsky Performance Status | Karnofsky Performance Status Due to Bone pain caused by Multiple Myeloma
Item
karnofsky performance score >or =70, or a performance score of 50-70 exclusively due to bone pain caused by myeloma
boolean
C0206065 (UMLS CUI [1])
C0206065 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0151825 (UMLS CUI [2,3])
C0015127 (UMLS CUI [2,4])
C0026764 (UMLS CUI [2,5])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Continuance of life Expected
Item
an expected survival greater than 3 months
boolean
C0038952 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet Count measurement
Item
anc >1,000/microliters, platelet count > 100,000/microliters
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Informed Consent | Informed Consent Donor
Item
donor and patient must have signed an irb-approved consent and been informed about the investigational nature of the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0040288 (UMLS CUI [2,2])
Donor HIV Serology negative
Item
donor must have negative serology for hiv
boolean
C0040288 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C0919674 (UMLS CUI [1,3])
Donor Relative Haploidentical | Donor Appropriate Leukapheresis | Donor Mismatch KIR Ligand Patient Graft vs Host Reaction
Item
available haplo-identical family donor fit to undergo leukapheresis and mismatched for kir-ligand(s) with the patient in the graft-versus host direction.
boolean
C0040288 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C3829897 (UMLS CUI [1,3])
C0040288 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0023416 (UMLS CUI [2,3])
C0040288 (UMLS CUI [3,1])
C1881865 (UMLS CUI [3,2])
C3642144 (UMLS CUI [3,3])
C0030705 (UMLS CUI [3,4])
C0018134 (UMLS CUI [3,5])
Cell storage CD34+ cell Autografting
Item
stored cells for autografting of at least 30 million cd34+ cells/kg
boolean
C2025607 (UMLS CUI [1,1])
C0882849 (UMLS CUI [1,2])
C0040736 (UMLS CUI [1,3])
Cell storage CD34+ cell Engraft failure
Item
back-up cells of at least 20 million cd34+ cells/kg in case of non-engraftment.
boolean
C2025607 (UMLS CUI [1,1])
C0882849 (UMLS CUI [1,2])
C2242642 (UMLS CUI [1,3])
Disease Response | M Protein In Urine | Urine light chain measurement | Serum Free Immunoglobulin Light Chain
Item
there must be an unambiguous marker for response to therapy in the first ten patients. therefore the patient must have detectable and quantifiable m-protein or light chain excretion in urine, light chain quantification in serum (freelite) or clear radiological signal lesion(s) in order to be eligible
boolean
C1704632 (UMLS CUI [1])
C0700271 (UMLS CUI [2,1])
C0042037 (UMLS CUI [2,2])
C1445962 (UMLS CUI [3])
C2827352 (UMLS CUI [4])
Recurrent disease | Toxic effect Acceptable | Multiple Myeloma High risk | Cytogenetic abnormalities | Metaphase Abnormal
Item
after 10 relapsed patients have been treated and toxicity is deemed acceptable, high-risk myeloma (defined as the presence of abnormal cytogenetics or metaphase analysis) patients without relapse can be entered
boolean
C0277556 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0026764 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C0008625 (UMLS CUI [4])
C1621812 (UMLS CUI [5,1])
C0205161 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Intravenous chemotherapy Affecting T-Lymphocyte | antibody therapy Intravenous Affecting T-Lymphocyte | Intravenous chemotherapy Affecting Natural Killer Cells | antibody therapy Intravenous Affecting Natural Killer Cells | Cyclophosphamide | Melphalan | Anti-Thymocyte Globulin | Campath 1H | fludarabine
Item
intravenous chemotherapy or antibody therapy affecting t-lymphocytes and/or natural killer cells e.g. cyclophosphamide, melphalan, atg, campath-1h etc. within the past 2 weeks prior to commencement of conditioning. last therapy is less than 14 days prior to starting fludarabine
boolean
C0413365 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0039194 (UMLS CUI [1,3])
C0281176 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0039194 (UMLS CUI [2,4])
C0413365 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0022688 (UMLS CUI [3,3])
C0281176 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0022688 (UMLS CUI [4,4])
C0010583 (UMLS CUI [5])
C0025241 (UMLS CUI [6])
C0003442 (UMLS CUI [7])
C1178562 (UMLS CUI [8])
C0059985 (UMLS CUI [9])
Fever | Communicable Disease Requirement Intravenous antibiotic therapy
Item
fever or active infection, requiring iv antibiotics
boolean
C0015967 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0559680 (UMLS CUI [2,3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver function: total bilirubin > 2xuln or ast/alt >3xuln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Renal function | Dialysis procedure
Item
renal function: patients on dialysis
boolean
C0232804 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
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