ID

37106

Description

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

Link

https://clinicaltrials.gov/show/NCT00547404

Keywords

Versions (2)
  1. 6/26/18 6/26/18 -
  2. 7/3/19 7/3/19 - Sarah Riepenhausen
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00547404

English

Eligibility Multiple Myeloma NCT00547404

1 forms  
Inclusion Criteria
Description

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
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
2. subjects must have relapsed or relapsed/refractory disease after at least 2 prior lines of therapy as defined in appendix d
Description

Recurrent disease | Refractory Disease | Status post Line of Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C4524693
UMLS CUI [3,3]
C1265611
3. monoclonal protein in the serum of equal to or greater than 1 gm/dl or monoclonal light chain in the urine protein electrophoresis of equal to or greater than 200 mg/24 hours, or measurable light chains by free light chain assay of equal to or greater than 10 mg/dl, or measurable plasmacytoma
Description

Monoclonal Protein Measurement Serum | Monoclonal free light chain present Urine protein electrophoresis | Immunoglobulin Light Chains Measurable | Free Immunoglobulin Light Chain Assay | Plasmacytoma Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C2984963
UMLS CUI [1,2]
C0229671
UMLS CUI [2,1]
C1532998
UMLS CUI [2,2]
C0201721
UMLS CUI [3,1]
C0021038
UMLS CUI [3,2]
C1513040
UMLS CUI [4,1]
C0806492
UMLS CUI [4,2]
C1510438
UMLS CUI [5,1]
C0032131
UMLS CUI [5,2]
C1513040
4. age ≥ 18 years at the time of signing the informed consent form
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. ecog performance status < 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. life expectancy > 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
7. subjects must have the following laboratory parameters:
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
hemoglobin > 8.0 gm/dl
Description

Hemoglobin measurement

Data type

boolean

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

Absolute neutrophil count

Data type

boolean

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

Platelet Count measurement

Data type

boolean

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

Aspartate aminotransferase measurement

Data type

boolean

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

Alanine aminotransferase measurement

Data type

boolean

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

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum total bilirubin <1.5 x institutional upper limits of normal (uln)
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0559892
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0241028
UMLS CUI [5,3]
C0700589
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0241028
UMLS CUI [6,3]
C0700589
UMLS CUI [7]
C2985296
UMLS CUI [8]
C0004764
UMLS CUI [9]
C0036899
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0038288
9. ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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
Description

Therapeutic radiology procedure | Immunotherapy | Chemotherapy | Biological Factors | G-CSF | Investigational New Drugs Adverse effects Recovery Lacking

Data type

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 [6,3]
C2004454
UMLS CUI [6,4]
C0332268
2. subjects having received any other investigational agents within 2 weeks prior to the date of enrolment
Description

Investigational New Drugs Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
3. history of allergic reactions attributed to compounds of similar chemical composition to p276-00
Description

Allergic Reaction Compound P276-00 Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C1832023
UMLS CUI [1,4]
C2348205
4. subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months
Description

Myocardial Infarction | Cardiac dysfunction Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C3277906
UMLS CUI [2,2]
C0205318
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0154088
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0012634
UMLS CUI [7,3]
C0332296
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0232174
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0003811
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0525058
UMLS CUI [8,3]
C0439801
7. women who are pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. subjects known to be seropositive for the human immunodeficiency virus
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
9. subjects requiring the use of concomitant medications that prolong the qt/qtc interval and/or are known to cause torsades de pointes (tdp)
Description

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval | Pharmaceutical Preparations Causing Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C1560305
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0040479
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
Description

Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
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Similar models

Eligibility Multiple Myeloma NCT00547404

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
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
boolean
C0026764 (UMLS CUI [1])
Recurrent disease | Refractory Disease | Status post Line of Therapy Quantity
Item
2. subjects must have relapsed or relapsed/refractory disease after at least 2 prior lines of therapy as defined in appendix d
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C4524693 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Monoclonal Protein Measurement Serum | Monoclonal free light chain present Urine protein electrophoresis | Immunoglobulin Light Chains Measurable | Free Immunoglobulin Light Chain Assay | Plasmacytoma Measurable
Item
3. monoclonal protein in the serum of equal to or greater than 1 gm/dl or monoclonal light chain in the urine protein electrophoresis of equal to or greater than 200 mg/24 hours, or measurable light chains by free light chain assay of equal to or greater than 10 mg/dl, or measurable plasmacytoma
boolean
C2984963 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C1532998 (UMLS CUI [2,1])
C0201721 (UMLS CUI [2,2])
C0021038 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
C0806492 (UMLS CUI [4,1])
C1510438 (UMLS CUI [4,2])
C0032131 (UMLS CUI [5,1])
C1513040 (UMLS CUI [5,2])
Age
Item
4. age ≥ 18 years at the time of signing the informed consent form
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status < 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Laboratory Results
Item
7. subjects must have the following laboratory parameters:
boolean
C1254595 (UMLS CUI [1])
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
Item
serum total bilirubin <1.5 x institutional upper limits of normal (uln)
boolean
C1278039 (UMLS CUI [1])
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
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
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0559892 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0241028 (UMLS CUI [5,2])
C0700589 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C0700589 (UMLS CUI [6,3])
C2985296 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0038288 (UMLS CUI [10,2])
Informed Consent
Item
9. ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Immunotherapy | Chemotherapy | Biological Factors | G-CSF | Investigational New Drugs Adverse effects Recovery Lacking
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
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 [6,3])
C0332268 (UMLS CUI [6,4])
Investigational New Drugs Other
Item
2. subjects having received any other investigational agents within 2 weeks prior to the date of enrolment
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Allergic Reaction Compound P276-00 Similar
Item
3. history of allergic reactions attributed to compounds of similar chemical composition to p276-00
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C1832023 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Myocardial Infarction | Cardiac dysfunction Uncontrolled
Item
4. subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months
boolean
C0027051 (UMLS CUI [1])
C3277906 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
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
Item
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
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0154088 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
C0332296 (UMLS CUI [7,3])
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
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
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0232174 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0525058 (UMLS CUI [8,2])
C0439801 (UMLS CUI [8,3])
Pregnancy | Breast Feeding
Item
7. women who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
8. subjects known to be seropositive for the human immunodeficiency virus
boolean
C0019699 (UMLS CUI [1])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Causing Prolonged QTc interval | Pharmaceutical Preparations Causing Torsades de Pointes
Item
9. subjects requiring the use of concomitant medications that prolong the qt/qtc interval and/or are known to cause torsades de pointes (tdp)
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1560305 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0040479 (UMLS CUI [3,3])
Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
Item
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
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
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