ID

18139

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00078065

Stichworte

Versionen (1)
  1. 22.10.16 22.10.16 -
Hochgeladen am

22. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00078065

Englisch

Eligibility Multiple Myeloma NCT00078065

1 Formulare  
Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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
Beschreibung

M Protein Serum Measurable | M Protein Urine Measurable

Datentyp

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
Beschreibung

Disease Progression | Recurrent disease | Therapeutic procedure Multiple Myeloma

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

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
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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.
Beschreibung

Hemoglobin | Red Blood Cell Transfusion | Erythropoietin

Datentyp

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
Beschreibung

White Blood Cell Count procedure | Absolute neutrophil count

Datentyp

boolean

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

Platelet Count measurement

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Serum total bilirubin measurement | Alanine aminotransferase measurement

Datentyp

boolean

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

Creatinine measurement, serum

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00078065

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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