ID

18231

Beschreibung

Busulfan Plus Melphalan Conditioning Regimen for Lymphoid Malignancies or Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00427765

Link

https://clinicaltrials.gov/show/NCT00427765

Stichworte

Versionen (1)
  1. 25.10.16 25.10.16 -
Hochgeladen am

25. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00427765

Englisch

Eligibility Multiple Myeloma NCT00427765

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with lymphoid malignancies, including hodgkin's and non-hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority.
Beschreibung

Malignant lymphoid neoplasm | Hodgkin's disease refractory | Hodgkin's disease recurrent | Non-Hodgkin's lymphoma refractory | Non-Hodgkin's lymphoma recurrent | Multiple Myeloma outside complete remission | Multiple Myeloma Unresponsive to Treatment | Multiple Myeloma In complete remission | Serum paraprotein level result Negative | Urine paraprotein level result Negative | immunoelectrophoresis | Immunofixation | bone marrow plasma cells Percentage

Datentyp

boolean

Alias
UMLS CUI [1]
C0746336
UMLS CUI [2]
C0855082
UMLS CUI [3]
C0746341
UMLS CUI [4]
C0854867
UMLS CUI [5]
C0854866
UMLS CUI [6,1]
C0026764
UMLS CUI [6,2]
C0205101
UMLS CUI [6,3]
C0677874
UMLS CUI [7,1]
C0026764
UMLS CUI [7,2]
C0205269
UMLS CUI [8,1]
C0026764
UMLS CUI [8,2]
C0677874
UMLS CUI [9,1]
C1318383
UMLS CUI [9,2]
C1513916
UMLS CUI [10,1]
C1318384
UMLS CUI [10,2]
C1513916
UMLS CUI [11]
C0020997
UMLS CUI [12]
C0430292
UMLS CUI [13,1]
C2238293
UMLS CUI [13,2]
C0439165
age 18 to 65 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < 1.8 mg/dl.
Beschreibung

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C2711451
adequate hepatic function, as defined by serum glutamic pyruvic transaminase (sgpt) < 3 * upper limit of normal; serum bilirubin and alkaline phosphatase < 2 * upper limit of normal, or considered not clinically significant.
Beschreibung

Liver function | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201850
adequate pulmonary function with forced expiratory volume in one second (fev1), forced vital capacity (fvc), and capacity of the lung for carbon monoxide (dlco)> 50%. exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (pi).
Beschreibung

Pulmonary function | FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test | pulmonary involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1287681
UMLS CUI [4]
C1516251
UMLS CUI [5]
C0748159
adequate cardiac function with left ventricular ejection fraction >/= 40%. no uncontrolled arrhythmias or symptomatic cardiac disease.
Beschreibung

Cardiac function | Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled | Heart Disease Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0231220
zubrod performance score < 2.
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
patients receiving an allogeneic transplant must have an hla matched, or one a, b, or dr mismatched related donor. unrelated donor must be matched at a, b, and dr (defined as a, b serologic matched and drb1 molecular matched). donor must be willing to donate peripheral blood or bone marrow progenitor cells.
Beschreibung

Transplantation, Homologous | Living related donor HLA Matched | Living related donor HLA-A Antigens Mismatch | Living related donor HLA-B Antigens Mismatch | Living related donor HLA-DR Antigens Mismatch | Unrelated Donor Matched Serologic HLA-A Antigens | Unrelated Donor Matched Serologic HLA-B Antigens | Unrelated Donor Matched Molecular HLA-DRB1 antigen | Donation peripheral blood Stem cells | Donation Bone Marrow Stem cells

Datentyp

boolean

Alias
UMLS CUI [1]
C0040739
UMLS CUI [2,1]
C3494891
UMLS CUI [2,2]
C1548978
UMLS CUI [3,1]
C3494891
UMLS CUI [3,2]
C0019728
UMLS CUI [3,3]
C1881865
UMLS CUI [4,1]
C3494891
UMLS CUI [4,2]
C0019737
UMLS CUI [4,3]
C1881865
UMLS CUI [5,1]
C3494891
UMLS CUI [5,2]
C0019764
UMLS CUI [5,3]
C1881865
UMLS CUI [6,1]
C3179133
UMLS CUI [6,2]
C1548978
UMLS CUI [6,3]
C0205473
UMLS CUI [6,4]
C0019728
UMLS CUI [7,1]
C3179133
UMLS CUI [7,2]
C1548978
UMLS CUI [7,3]
C0205473
UMLS CUI [7,4]
C0019737
UMLS CUI [8,1]
C3179133
UMLS CUI [8,2]
C1548978
UMLS CUI [8,3]
C1521991
UMLS CUI [8,4]
C0122040
UMLS CUI [9,1]
C0080231
UMLS CUI [9,2]
C0229664
UMLS CUI [9,3]
C0038250
UMLS CUI [10,1]
C0080231
UMLS CUI [10,2]
C0005953
UMLS CUI [10,3]
C0038250
patient and donor should be willing to participate in the study by providing written consent.
Beschreibung

Informed Consent | Informed Consent Donor

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0040288
female patient must not be pregnant and have negative pregnancy.
Beschreibung

Pregnancy | Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with unresolved grade >/= 3 non-hematologic toxicity from previous therapy. patients with grade 2 toxicity will be eligible at the discretion of the pi.
Beschreibung

Toxicity Unresolved Due to Prior Therapy | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0443342
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1514463
UMLS CUI [2]
C1516728
patients with active central nervous system (cns) disease.
Beschreibung

CNS disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
evidence of acute or chronic active hepatitis or cirrhosis. if positive hepatitis serology, discuss with study chairman and consider liver biopsy.
Beschreibung

Hepatitis Evidence of | Chronic Hepatitis Evidence of | Liver Cirrhosis Evidence of | Chronic Liver Cirrhosis Evidence of | hepatitis serology Positive | Biopsy of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019158
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0019189
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0332120
UMLS CUI [5,1]
C0744862
UMLS CUI [5,2]
C1514241
UMLS CUI [6]
C0193388
uncontrolled infection, including human immunodeficiency virus (hiv) or human t-lymphotropic virus type i (htlv-1) infection.
Beschreibung

Communicable Disease Uncontrolled | HIV Infection | HTLV-I Infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0020097
patients who have had a previous autologous or allogeneic stem cell transplant during the past year.
Beschreibung

Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C2242529
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00427765

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Malignant lymphoid neoplasm | Hodgkin's disease refractory | Hodgkin's disease recurrent | Non-Hodgkin's lymphoma refractory | Non-Hodgkin's lymphoma recurrent | Multiple Myeloma outside complete remission | Multiple Myeloma Unresponsive to Treatment | Multiple Myeloma In complete remission | Serum paraprotein level result Negative | Urine paraprotein level result Negative | immunoelectrophoresis | Immunofixation | bone marrow plasma cells Percentage
Item
patients with lymphoid malignancies, including hodgkin's and non-hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority.
boolean
C0746336 (UMLS CUI [1])
C0855082 (UMLS CUI [2])
C0746341 (UMLS CUI [3])
C0854867 (UMLS CUI [4])
C0854866 (UMLS CUI [5])
C0026764 (UMLS CUI [6,1])
C0205101 (UMLS CUI [6,2])
C0677874 (UMLS CUI [6,3])
C0026764 (UMLS CUI [7,1])
C0205269 (UMLS CUI [7,2])
C0026764 (UMLS CUI [8,1])
C0677874 (UMLS CUI [8,2])
C1318383 (UMLS CUI [9,1])
C1513916 (UMLS CUI [9,2])
C1318384 (UMLS CUI [10,1])
C1513916 (UMLS CUI [10,2])
C0020997 (UMLS CUI [11])
C0430292 (UMLS CUI [12])
C2238293 (UMLS CUI [13,1])
C0439165 (UMLS CUI [13,2])
Age
Item
age 18 to 65 years of age.
boolean
C0001779 (UMLS CUI [1])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < 1.8 mg/dl.
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Liver function | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement
Item
adequate hepatic function, as defined by serum glutamic pyruvic transaminase (sgpt) < 3 * upper limit of normal; serum bilirubin and alkaline phosphatase < 2 * upper limit of normal, or considered not clinically significant.
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Pulmonary function | FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test | pulmonary involvement
Item
adequate pulmonary function with forced expiratory volume in one second (fev1), forced vital capacity (fvc), and capacity of the lung for carbon monoxide (dlco)> 50%. exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (pi).
boolean
C0231921 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C1287681 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
C0748159 (UMLS CUI [5])
Cardiac function | Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled | Heart Disease Symptomatic
Item
adequate cardiac function with left ventricular ejection fraction >/= 40%. no uncontrolled arrhythmias or symptomatic cardiac disease.
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Zubrod Performance Status
Item
zubrod performance score < 2.
boolean
C3714786 (UMLS CUI [1])
Transplantation, Homologous | Living related donor HLA Matched | Living related donor HLA-A Antigens Mismatch | Living related donor HLA-B Antigens Mismatch | Living related donor HLA-DR Antigens Mismatch | Unrelated Donor Matched Serologic HLA-A Antigens | Unrelated Donor Matched Serologic HLA-B Antigens | Unrelated Donor Matched Molecular HLA-DRB1 antigen | Donation peripheral blood Stem cells | Donation Bone Marrow Stem cells
Item
patients receiving an allogeneic transplant must have an hla matched, or one a, b, or dr mismatched related donor. unrelated donor must be matched at a, b, and dr (defined as a, b serologic matched and drb1 molecular matched). donor must be willing to donate peripheral blood or bone marrow progenitor cells.
boolean
C0040739 (UMLS CUI [1])
C3494891 (UMLS CUI [2,1])
C1548978 (UMLS CUI [2,2])
C3494891 (UMLS CUI [3,1])
C0019728 (UMLS CUI [3,2])
C1881865 (UMLS CUI [3,3])
C3494891 (UMLS CUI [4,1])
C0019737 (UMLS CUI [4,2])
C1881865 (UMLS CUI [4,3])
C3494891 (UMLS CUI [5,1])
C0019764 (UMLS CUI [5,2])
C1881865 (UMLS CUI [5,3])
C3179133 (UMLS CUI [6,1])
C1548978 (UMLS CUI [6,2])
C0205473 (UMLS CUI [6,3])
C0019728 (UMLS CUI [6,4])
C3179133 (UMLS CUI [7,1])
C1548978 (UMLS CUI [7,2])
C0205473 (UMLS CUI [7,3])
C0019737 (UMLS CUI [7,4])
C3179133 (UMLS CUI [8,1])
C1548978 (UMLS CUI [8,2])
C1521991 (UMLS CUI [8,3])
C0122040 (UMLS CUI [8,4])
C0080231 (UMLS CUI [9,1])
C0229664 (UMLS CUI [9,2])
C0038250 (UMLS CUI [9,3])
C0080231 (UMLS CUI [10,1])
C0005953 (UMLS CUI [10,2])
C0038250 (UMLS CUI [10,3])
Informed Consent | Informed Consent Donor
Item
patient and donor should be willing to participate in the study by providing written consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0040288 (UMLS CUI [2,2])
Pregnancy | Pregnancy test negative
Item
female patient must not be pregnant and have negative pregnancy.
boolean
C0032961 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Toxicity Unresolved Due to Prior Therapy | CTCAE Grades
Item
patients with unresolved grade >/= 3 non-hematologic toxicity from previous therapy. patients with grade 2 toxicity will be eligible at the discretion of the pi.
boolean
C0600688 (UMLS CUI [1,1])
C0443342 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
C1516728 (UMLS CUI [2])
CNS disorder
Item
patients with active central nervous system (cns) disease.
boolean
C0007682 (UMLS CUI [1])
Hepatitis Evidence of | Chronic Hepatitis Evidence of | Liver Cirrhosis Evidence of | Chronic Liver Cirrhosis Evidence of | hepatitis serology Positive | Biopsy of liver
Item
evidence of acute or chronic active hepatitis or cirrhosis. if positive hepatitis serology, discuss with study chairman and consider liver biopsy.
boolean
C0019158 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0019189 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0023890 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C0023890 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0332120 (UMLS CUI [4,3])
C0744862 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
C0193388 (UMLS CUI [6])
Communicable Disease Uncontrolled | HIV Infection | HTLV-I Infection
Item
uncontrolled infection, including human immunodeficiency virus (hiv) or human t-lymphotropic virus type i (htlv-1) infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2])
C0020097 (UMLS CUI [3])
Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation
Item
patients who have had a previous autologous or allogeneic stem cell transplant during the past year.
boolean
C1831743 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
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