ID

18139

Beschrijving

Xcellerated T CellsTM in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00078065

Link

https://clinicaltrials.gov/show/NCT00078065

Trefwoorden

  1. 22-10-16 22-10-16 -
Geüploaded op

22 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00078065

Eligibility Multiple Myeloma NCT00078065

Criteria
Beschrijving

Criteria

failure of at least one, but no more than four, prior systemic therapies for mm prior to registration and may not have relapsed or progressed within 1 year following autologous hematopoietic stem cell transplantation. repeat courses of the same therapeutic regimen separated in time by 6 or more months are considered separate therapies. induction therapy followed by high dose chemotherapy and autologous hematopoietic stem cell transplantation counts as one therapy.
Beschrijving

Multiple Myeloma | Systemic therapy Quantity failed | Recurrent disease | Disease Progression | Transplantation of autologous hematopoietic stem cell | Neoadjuvant Therapy | high-dose chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0277556
UMLS CUI [4]
C0242656
UMLS CUI [5]
C1831743
UMLS CUI [6]
C0600558
UMLS CUI [7]
C1328050
measurable serum and/or urine m-protein
Beschrijving

M Protein Serum Measurable | M Protein Urine Measurable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0042036
UMLS CUI [2,3]
C1513040
disease progression or relapse, since most recent therapy for multiple myeloma
Beschrijving

Disease Progression | Recurrent disease | Therapeutic procedure Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0026764
age > 18 years old and < 75 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
females of child-bearing potential must have a negative serum bhcg test and be willing to use effective contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the trial
Beschrijving

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0009907
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0087145
UMLS CUI [7]
C0221829
UMLS CUI [8]
C0036899
negative test results for current/active infection with hiv-1, hiv-2, htlv-1, htlv-2, hepatitis b, and hepatitis c within 30 days of registration (antibody, antigen, and nucleic acid tests acceptable, depending on institutional standards)
Beschrijving

HIV-1 infection Negative Test Result | HIV-2 infection Negative Test Result | Human T-lymphotropic virus 1 Negative Test Result | Human T-lymphotropic virus 2 Negative Test Result | Hepatitis B Negative Test Result | Hepatitis C Negative Test Result | Antibody test Acceptable | Antigen test Acceptable | Nucleic Acid Testing Acceptable

Datatype

boolean

Alias
UMLS CUI [1,1]
C2363741
UMLS CUI [1,2]
C1334932
UMLS CUI [2,1]
C0854094
UMLS CUI [2,2]
C1334932
UMLS CUI [3,1]
C0020094
UMLS CUI [3,2]
C1334932
UMLS CUI [4,1]
C0020099
UMLS CUI [4,2]
C1334932
UMLS CUI [5,1]
C0019163
UMLS CUI [5,2]
C1334932
UMLS CUI [6,1]
C0019196
UMLS CUI [6,2]
C1334932
UMLS CUI [7,1]
C0580327
UMLS CUI [7,2]
C1879533
UMLS CUI [8,1]
C0729856
UMLS CUI [8,2]
C1879533
UMLS CUI [9,1]
C0200932
UMLS CUI [9,2]
C1879533
hemoglobin >= 10.0 g/dl. transfusion with red blood cells or use of erythropoietin is permissible.
Beschrijving

Hemoglobin | Red Blood Cell Transfusion | Erythropoietin

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0086252
UMLS CUI [3]
C0014822
white blood count (wbc) >= 3,000/mm3 and absolute neutrophil count (anc) > 1000/mm3
Beschrijving

White Blood Cell Count procedure | Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
platelet count > 75,000/mm3
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
corrected serum calcium < 11 mg/dl, and no evidence of symptomatic hypercalcemia. (corrected serum calcium is calculated by adding 0.8 mg/dl to the measured serum calcium for every 1 g/dl that the serum albumin falls below 4.0 g/dl)
Beschrijving

Corrected serum calcium measurement | Hypercalcemia Symptomatic Evidence | Serum calcium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0455288
UMLS CUI [2,1]
C0020437
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C3887511
UMLS CUI [3]
C0728876
serum total bilirubin and alanine aminotransferase (alt) < 2.0 times the upper limit of normal
Beschrijving

Serum total bilirubin measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
serum creatinine < 2.5 mg/dl
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
serum human anti-mouse antibody (hama) titer undetectable or within the normal range, and no history of allergies to mice or murine (mouse) proteins
Beschrijving

Human anti-mouse antibody Serologic titer Undetectable | Human anti-mouse antibody Serologic titer Normal | Hypersensitivity Mus | Hypersensitivity murine protein

Datatype

boolean

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C0312544
UMLS CUI [1,3]
C3827727
UMLS CUI [2,1]
C1291910
UMLS CUI [2,2]
C0312544
UMLS CUI [2,3]
C0205307
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0026809
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1699668
the patient must be able to comprehend and have signed the informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Multiple Myeloma NCT00078065

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Multiple Myeloma | Systemic therapy Quantity failed | Recurrent disease | Disease Progression | Transplantation of autologous hematopoietic stem cell | Neoadjuvant Therapy | high-dose chemotherapy
Item
failure of at least one, but no more than four, prior systemic therapies for mm prior to registration and may not have relapsed or progressed within 1 year following autologous hematopoietic stem cell transplantation. repeat courses of the same therapeutic regimen separated in time by 6 or more months are considered separate therapies. induction therapy followed by high dose chemotherapy and autologous hematopoietic stem cell transplantation counts as one therapy.
boolean
C0026764 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C1831743 (UMLS CUI [5])
C0600558 (UMLS CUI [6])
C1328050 (UMLS CUI [7])
M Protein Serum Measurable | M Protein Urine Measurable
Item
measurable serum and/or urine m-protein
boolean
C0700271 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0700271 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
Disease Progression | Recurrent disease | Therapeutic procedure Multiple Myeloma
Item
disease progression or relapse, since most recent therapy for multiple myeloma
boolean
C0242656 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
Age
Item
age > 18 years old and < 75 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence
Item
females of child-bearing potential must have a negative serum bhcg test and be willing to use effective contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the trial
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0009907 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
HIV-1 infection Negative Test Result | HIV-2 infection Negative Test Result | Human T-lymphotropic virus 1 Negative Test Result | Human T-lymphotropic virus 2 Negative Test Result | Hepatitis B Negative Test Result | Hepatitis C Negative Test Result | Antibody test Acceptable | Antigen test Acceptable | Nucleic Acid Testing Acceptable
Item
negative test results for current/active infection with hiv-1, hiv-2, htlv-1, htlv-2, hepatitis b, and hepatitis c within 30 days of registration (antibody, antigen, and nucleic acid tests acceptable, depending on institutional standards)
boolean
C2363741 (UMLS CUI [1,1])
C1334932 (UMLS CUI [1,2])
C0854094 (UMLS CUI [2,1])
C1334932 (UMLS CUI [2,2])
C0020094 (UMLS CUI [3,1])
C1334932 (UMLS CUI [3,2])
C0020099 (UMLS CUI [4,1])
C1334932 (UMLS CUI [4,2])
C0019163 (UMLS CUI [5,1])
C1334932 (UMLS CUI [5,2])
C0019196 (UMLS CUI [6,1])
C1334932 (UMLS CUI [6,2])
C0580327 (UMLS CUI [7,1])
C1879533 (UMLS CUI [7,2])
C0729856 (UMLS CUI [8,1])
C1879533 (UMLS CUI [8,2])
C0200932 (UMLS CUI [9,1])
C1879533 (UMLS CUI [9,2])
Hemoglobin | Red Blood Cell Transfusion | Erythropoietin
Item
hemoglobin >= 10.0 g/dl. transfusion with red blood cells or use of erythropoietin is permissible.
boolean
C0019046 (UMLS CUI [1])
C0086252 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
White Blood Cell Count procedure | Absolute neutrophil count
Item
white blood count (wbc) >= 3,000/mm3 and absolute neutrophil count (anc) > 1000/mm3
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count > 75,000/mm3
boolean
C0032181 (UMLS CUI [1])
Corrected serum calcium measurement | Hypercalcemia Symptomatic Evidence | Serum calcium measurement
Item
corrected serum calcium < 11 mg/dl, and no evidence of symptomatic hypercalcemia. (corrected serum calcium is calculated by adding 0.8 mg/dl to the measured serum calcium for every 1 g/dl that the serum albumin falls below 4.0 g/dl)
boolean
C0455288 (UMLS CUI [1])
C0020437 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0728876 (UMLS CUI [3])
Serum total bilirubin measurement | Alanine aminotransferase measurement
Item
serum total bilirubin and alanine aminotransferase (alt) < 2.0 times the upper limit of normal
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine < 2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Human anti-mouse antibody Serologic titer Undetectable | Human anti-mouse antibody Serologic titer Normal | Hypersensitivity Mus | Hypersensitivity murine protein
Item
serum human anti-mouse antibody (hama) titer undetectable or within the normal range, and no history of allergies to mice or murine (mouse) proteins
boolean
C1291910 (UMLS CUI [1,1])
C0312544 (UMLS CUI [1,2])
C3827727 (UMLS CUI [1,3])
C1291910 (UMLS CUI [2,1])
C0312544 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0026809 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1699668 (UMLS CUI [4,2])
Informed Consent
Item
the patient must be able to comprehend and have signed the informed consent
boolean
C0021430 (UMLS CUI [1])

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