ID

30842

Beskrivning

Phase I Study for Safety and Efficacy of P276-00 in Subjects With Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00547404

Länk

https://clinicaltrials.gov/show/NCT00547404

Nyckelord

Versioner (2)
  1. 2018-06-26 2018-06-26 -
  2. 2019-07-03 2019-07-03 - Sarah Riepenhausen
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 juni 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT00547404

Engelsk

Eligibility Multiple Myeloma NCT00547404

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject previously diagnosed with multiple myeloma based either on the standard or the international myeloma foundation (imf) diagnostic criteria as defined in appendix a 2. subjects must have relapsed or relapsed/refractory disease after at least 2 prior lines of therapy as defined in appendix d 3. monoclonal protein in the serum of
Beskrivning

Multiple Myeloma | Recurrent disease | Refractory Disease | Status post Line of Therapy Quantity | Monoclonal Protein Measurement Serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C4524693
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C2984963
UMLS CUI [5,2]
C0229671
³ 1 gm/dl or monoclonal light chain in the urine protein electrophoresis of ³ 200 mg/
Beskrivning

Monoclonal free light chain present Urine protein electrophoresis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1532998
UMLS CUI [1,2]
C0201721
24 hours, or measurable light chains by free light chain assay of ³ 10 mg/dl, or measurable plasmacytoma 4. age ≥ 18 years at the time of signing the informed consent form 5. ecog performance status < 2 6. life expectancy > 3 months 7. subjects must have the following laboratory parameters:
Beskrivning

Immunoglobulin Light Chains Measurable | Free Immunoglobulin Light Chain Assay | Plasmacytoma Measurable | Age | ECOG performance status | Life Expectancy | Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021038
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C0806492
UMLS CUI [2,2]
C1510438
UMLS CUI [3,1]
C0032131
UMLS CUI [3,2]
C1513040
UMLS CUI [4]
C0001779
UMLS CUI [5]
C1520224
UMLS CUI [6]
C0023671
UMLS CUI [7]
C1254595
hemoglobin > 8.0 gm/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
absolute neutrophil count (anc) ≥1000 cells/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets count ≥ 50,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
serum sgot/ast <3.0 x institutional upper limits of normal (uln)
Beskrivning

Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
serum sgpt/alt <3.0 x institutional upper limits of normal (uln)
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
serum creatinine <2.5mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
serum total bilirubin <1.5 x institutional upper limits of normal (uln) 8. woman of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months) with a negative serum pregnancy test. in addition, all sexually active woman of childbearing potential and men agreeing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised 9. ability to understand and the willingness to sign a written informed consent document
Beskrivning

Serum total bilirubin measurement | Childbearing Potential Serum pregnancy test negative | Hysterectomy Absent | Postmenopausal state Absent | Normal menstruation | Childbearing Potential Sexually active Contraceptive methods | Gender Sexually active Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Exception Sterilization | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
UMLS CUI [3,1]
C0020699
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0559892
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0241028
UMLS CUI [6,3]
C0700589
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0241028
UMLS CUI [7,3]
C0700589
UMLS CUI [8]
C2985296
UMLS CUI [9]
C0004764
UMLS CUI [10]
C0036899
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0038288
UMLS CUI [12]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects having received radiotherapy, immunotherapy, chemotherapy and or biological agents like g-csf in the 2 weeks prior to day 1 of study drug administration and have not recovered completely from the side effects of the earlier investigational agent 2. subjects having received any other investigational agents within 2 weeks prior to the date of enrolment 3. history of allergic reactions attributed to compounds of similar chemical composition to p276-00 4. subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months 5. prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years 6. subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, known cardiac ejection fraction <40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 7. women who are pregnant or nursing 8. subjects known to be seropositive for the human immunodeficiency virus 9. subjects requiring the use of concomitant medications that prolong the qt/qtc interval and/or are known to cause torsades de pointes (tdp) 10. any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
Beskrivning

Therapeutic radiology procedure | Immunotherapy | Chemotherapy | Biological Factors | G-CSF | Investigational New Drugs Adverse effects | Recovery Lacking | Investigational New Drugs Other | Allergic Reaction Compound P276-00 Similar | Myocardial Infarction | Cardiac dysfunction Uncontrolled | Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Carcinoma in situ of prostate Treated | Exception Disease Free of | Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Cardiac ejection fraction | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited | Pregnancy | Breast Feeding | HIV Seropositivity | Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval | Pharmaceutical Preparations Causing Torsades de Pointes | Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0021083
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0005515
UMLS CUI [5]
C0079459
UMLS CUI [6,1]
C0013230
UMLS CUI [6,2]
C0879626
UMLS CUI [7,1]
C2004454
UMLS CUI [7,2]
C0332268
UMLS CUI [8,1]
C0013230
UMLS CUI [8,2]
C0205394
UMLS CUI [9,1]
C1527304
UMLS CUI [9,2]
C1706082
UMLS CUI [9,3]
C1832023
UMLS CUI [9,4]
C2348205
UMLS CUI [10]
C0027051
UMLS CUI [11,1]
C3277906
UMLS CUI [11,2]
C0205318
UMLS CUI [12]
C0006826
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0007117
UMLS CUI [13,3]
C1522326
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0553723
UMLS CUI [14,3]
C1522326
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C0851140
UMLS CUI [15,3]
C1522326
UMLS CUI [16,1]
C1705847
UMLS CUI [16,2]
C0686288
UMLS CUI [16,3]
C1522326
UMLS CUI [17,1]
C1705847
UMLS CUI [17,2]
C0154088
UMLS CUI [17,3]
C1522326
UMLS CUI [18,1]
C1705847
UMLS CUI [18,2]
C0012634
UMLS CUI [18,3]
C0332296
UMLS CUI [19,1]
C0009488
UMLS CUI [19,2]
C0205318
UMLS CUI [20]
C0009450
UMLS CUI [21]
C0742758
UMLS CUI [22]
C0232174
UMLS CUI [23]
C0002965
UMLS CUI [24]
C0003811
UMLS CUI [25,1]
C0004936
UMLS CUI [25,2]
C0525058
UMLS CUI [25,3]
C0439801
UMLS CUI [26,1]
C0748872
UMLS CUI [26,2]
C0525058
UMLS CUI [26,3]
C0439801
UMLS CUI [27]
C0032961
UMLS CUI [28]
C0006147
UMLS CUI [29]
C0019699
UMLS CUI [30,1]
C0013227
UMLS CUI [30,2]
C0678227
UMLS CUI [30,3]
C0151878
UMLS CUI [31,1]
C0013227
UMLS CUI [31,2]
C0678227
UMLS CUI [31,3]
C1560305
UMLS CUI [32,1]
C0013227
UMLS CUI [32,2]
C0678227
UMLS CUI [32,3]
C0040479
UMLS CUI [33,1]
C0348080
UMLS CUI [33,2]
C2348568
UMLS CUI [33,3]
C1444641
UMLS CUI [34,1]
C0438215
UMLS CUI [34,2]
C2348568
UMLS CUI [34,3]
C1444641
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Similar models

Eligibility Multiple Myeloma NCT00547404

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Recurrent disease | Refractory Disease | Status post Line of Therapy Quantity | Monoclonal Protein Measurement Serum
Item
1. subject previously diagnosed with multiple myeloma based either on the standard or the international myeloma foundation (imf) diagnostic criteria as defined in appendix a 2. subjects must have relapsed or relapsed/refractory disease after at least 2 prior lines of therapy as defined in appendix d 3. monoclonal protein in the serum of
boolean
C0026764 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C4524693 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C2984963 (UMLS CUI [5,1])
C0229671 (UMLS CUI [5,2])
Monoclonal free light chain present Urine protein electrophoresis
Item
³ 1 gm/dl or monoclonal light chain in the urine protein electrophoresis of ³ 200 mg/
boolean
C1532998 (UMLS CUI [1,1])
C0201721 (UMLS CUI [1,2])
Immunoglobulin Light Chains Measurable | Free Immunoglobulin Light Chain Assay | Plasmacytoma Measurable | Age | ECOG performance status | Life Expectancy | Laboratory Results
Item
24 hours, or measurable light chains by free light chain assay of ³ 10 mg/dl, or measurable plasmacytoma 4. age ≥ 18 years at the time of signing the informed consent form 5. ecog performance status < 2 6. life expectancy > 3 months 7. subjects must have the following laboratory parameters:
boolean
C0021038 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0806492 (UMLS CUI [2,1])
C1510438 (UMLS CUI [2,2])
C0032131 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C1520224 (UMLS CUI [5])
C0023671 (UMLS CUI [6])
C1254595 (UMLS CUI [7])
Hemoglobin measurement
Item
hemoglobin > 8.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥1000 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets count ≥ 50,000/mm3
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
serum sgot/ast <3.0 x institutional upper limits of normal (uln)
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
serum sgpt/alt <3.0 x institutional upper limits of normal (uln)
boolean
C0201836 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine <2.5mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Childbearing Potential Serum pregnancy test negative | Hysterectomy Absent | Postmenopausal state Absent | Normal menstruation | Childbearing Potential Sexually active Contraceptive methods | Gender Sexually active Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Exception Sterilization | Informed Consent
Item
serum total bilirubin <1.5 x institutional upper limits of normal (uln) 8. woman of childbearing potential [defined as a sexually mature woman who has not undergone hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e. who has had menses any time in the preceding 24 consecutive months) with a negative serum pregnancy test. in addition, all sexually active woman of childbearing potential and men agreeing to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised 9. ability to understand and the willingness to sign a written informed consent document
boolean
C1278039 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C0020699 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0559892 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C0700589 (UMLS CUI [6,3])
C0079399 (UMLS CUI [7,1])
C0241028 (UMLS CUI [7,2])
C0700589 (UMLS CUI [7,3])
C2985296 (UMLS CUI [8])
C0004764 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0038288 (UMLS CUI [11,2])
C0021430 (UMLS CUI [12])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Immunotherapy | Chemotherapy | Biological Factors | G-CSF | Investigational New Drugs Adverse effects | Recovery Lacking | Investigational New Drugs Other | Allergic Reaction Compound P276-00 Similar | Myocardial Infarction | Cardiac dysfunction Uncontrolled | Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated | Exception Carcinoma in situ of prostate Treated | Exception Disease Free of | Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Cardiac ejection fraction | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited | Pregnancy | Breast Feeding | HIV Seropositivity | Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval | Pharmaceutical Preparations Causing Torsades de Pointes | Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
Item
1. subjects having received radiotherapy, immunotherapy, chemotherapy and or biological agents like g-csf in the 2 weeks prior to day 1 of study drug administration and have not recovered completely from the side effects of the earlier investigational agent 2. subjects having received any other investigational agents within 2 weeks prior to the date of enrolment 3. history of allergic reactions attributed to compounds of similar chemical composition to p276-00 4. subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months 5. prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the subject has been disease-free for at least 3 years 6. subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, known cardiac ejection fraction <40%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 7. women who are pregnant or nursing 8. subjects known to be seropositive for the human immunodeficiency virus 9. subjects requiring the use of concomitant medications that prolong the qt/qtc interval and/or are known to cause torsades de pointes (tdp) 10. any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
boolean
C1522449 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0005515 (UMLS CUI [4])
C0079459 (UMLS CUI [5])
C0013230 (UMLS CUI [6,1])
C0879626 (UMLS CUI [6,2])
C2004454 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
C0013230 (UMLS CUI [8,1])
C0205394 (UMLS CUI [8,2])
C1527304 (UMLS CUI [9,1])
C1706082 (UMLS CUI [9,2])
C1832023 (UMLS CUI [9,3])
C2348205 (UMLS CUI [9,4])
C0027051 (UMLS CUI [10])
C3277906 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
C0006826 (UMLS CUI [12])
C1705847 (UMLS CUI [13,1])
C0007117 (UMLS CUI [13,2])
C1522326 (UMLS CUI [13,3])
C1705847 (UMLS CUI [14,1])
C0553723 (UMLS CUI [14,2])
C1522326 (UMLS CUI [14,3])
C1705847 (UMLS CUI [15,1])
C0851140 (UMLS CUI [15,2])
C1522326 (UMLS CUI [15,3])
C1705847 (UMLS CUI [16,1])
C0686288 (UMLS CUI [16,2])
C1522326 (UMLS CUI [16,3])
C1705847 (UMLS CUI [17,1])
C0154088 (UMLS CUI [17,2])
C1522326 (UMLS CUI [17,3])
C1705847 (UMLS CUI [18,1])
C0012634 (UMLS CUI [18,2])
C0332296 (UMLS CUI [18,3])
C0009488 (UMLS CUI [19,1])
C0205318 (UMLS CUI [19,2])
C0009450 (UMLS CUI [20])
C0742758 (UMLS CUI [21])
C0232174 (UMLS CUI [22])
C0002965 (UMLS CUI [23])
C0003811 (UMLS CUI [24])
C0004936 (UMLS CUI [25,1])
C0525058 (UMLS CUI [25,2])
C0439801 (UMLS CUI [25,3])
C0748872 (UMLS CUI [26,1])
C0525058 (UMLS CUI [26,2])
C0439801 (UMLS CUI [26,3])
C0032961 (UMLS CUI [27])
C0006147 (UMLS CUI [28])
C0019699 (UMLS CUI [29])
C0013227 (UMLS CUI [30,1])
C0678227 (UMLS CUI [30,2])
C0151878 (UMLS CUI [30,3])
C0013227 (UMLS CUI [31,1])
C0678227 (UMLS CUI [31,2])
C1560305 (UMLS CUI [31,3])
C0013227 (UMLS CUI [32,1])
C0678227 (UMLS CUI [32,2])
C0040479 (UMLS CUI [32,3])
C0348080 (UMLS CUI [33,1])
C2348568 (UMLS CUI [33,2])
C1444641 (UMLS CUI [33,3])
C0438215 (UMLS CUI [34,1])
C2348568 (UMLS CUI [34,2])
C1444641 (UMLS CUI [34,3])
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