ID

31754

Description

Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00882063

Link

https://clinicaltrials.gov/show/NCT00882063

Keywords

  1. 9/26/18 9/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 26, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Relapsed and/or Refractory Multiple Myeloma NCT00882063

Eligibility Relapsed and/or Refractory Multiple Myeloma NCT00882063

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria 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 and/or relapsed/refractory disease after at least 2 prior lines of therapy as defined in appendix d.
Description

Recurrent disease | Refractory Disease | Status post Therapy Course Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0750729
UMLS CUI [3,4]
C1265611
3. monoclonal protein in the serum of > or = 1 g/dl or monoclonal light chain in the urine protein electrophoresis of > or = 200 mg/ 24 hours, or measurable light chains by free light chain assay of > or = 10 mg/dl, or measurable plasmacytoma.
Description

Serum Monoclonal Protein Measurement | Monoclonal free light chain present 24-hour urine protein electrophoresis | Light chain measurement Free Light Chain Assay | Plasmacytoma Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C2984963
UMLS CUI [2,1]
C1532998
UMLS CUI [2,2]
C2321676
UMLS CUI [3,1]
C1562562
UMLS CUI [3,2]
C0806492
UMLS CUI [3,3]
C1510438
UMLS CUI [4,1]
C0032131
UMLS CUI [4,2]
C1513040
4. age > or = 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 < or = 2
Description

ECOG performance status

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Laboratory parameters

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0449381
hemoglobin > or = 8.0 gm/dl
Description

Hemoglobin measurement

Data type

boolean

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

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets count > or = 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 women 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 | Females & males of reproductive potential Sexually active Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Exception Sexual sterilization

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]
C4034483
UMLS CUI [5,2]
C0241028
UMLS CUI [5,3]
C0700589
UMLS CUI [6]
C2985296
UMLS CUI [7]
C0004764
UMLS CUI [8]
C0036899
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
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 4 weeks prior to day 1 of study drug administration or have not recovered (grade < or = 1) from adverse effects of such therapy received prior to 4 weeks
Description

Therapeutic radiology procedure | Immunotherapy | Chemotherapy | Biological agents | G-CSF | Therapeutic procedure Adverse effects CTCAE Grades | Recovery Absent

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]
C0087111
UMLS CUI [6,2]
C0879626
UMLS CUI [6,3]
C1516728
UMLS CUI [7,1]
C2004454
UMLS CUI [7,2]
C0332197
2. subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks.
Description

Investigational New Drugs | Investigational New Drugs Adverse effects | Recovery Absent

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0879626
UMLS CUI [3,1]
C2004454
UMLS CUI [3,2]
C0332197
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 Cancer Other 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]
C1707251
UMLS CUI [7,3]
C0012634
UMLS CUI [7,4]
C0332296
6. subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, 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 disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

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]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
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 or any history or evidence from physical examination of hiv infection.
Description

HIV Seropositivity | Medical History HIV Infection | HIV Infection Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0019693
UMLS CUI [3,1]
C0019693
UMLS CUI [3,2]
C0031809
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

Concomitant Agent Causing Prolonged QT interval | Concomitant Agent Causing Prolonged QTc interval | Concomitant Agent Causing Torsades de Pointes

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C1560305
UMLS CUI [3,1]
C2347852
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

Similar models

Eligibility Relapsed and/or Refractory Multiple Myeloma NCT00882063

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
1. subjects previously diagnosed with multiple myeloma based either on the standard diagnostic criteria or the international myeloma foundation (imf) diagnostic criteria as defined in appendix a.
boolean
C0026764 (UMLS CUI [1])
Recurrent disease | Refractory Disease | Status post Therapy Course Quantity
Item
2. subjects must have relapsed and/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])
C0087111 (UMLS CUI [3,2])
C0750729 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Serum Monoclonal Protein Measurement | Monoclonal free light chain present 24-hour urine protein electrophoresis | Light chain measurement Free Light Chain Assay | Plasmacytoma Measurable
Item
3. monoclonal protein in the serum of > or = 1 g/dl or monoclonal light chain in the urine protein electrophoresis of > or = 200 mg/ 24 hours, or measurable light chains by free light chain assay of > or = 10 mg/dl, or measurable plasmacytoma.
boolean
C0229671 (UMLS CUI [1,1])
C2984963 (UMLS CUI [1,2])
C1532998 (UMLS CUI [2,1])
C2321676 (UMLS CUI [2,2])
C1562562 (UMLS CUI [3,1])
C0806492 (UMLS CUI [3,2])
C1510438 (UMLS CUI [3,3])
C0032131 (UMLS CUI [4,1])
C1513040 (UMLS CUI [4,2])
Age
Item
4. age > or = 18 years at the time of signing the informed consent form
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status < or = 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy > or = 3 months
boolean
C0023671 (UMLS CUI [1])
Laboratory parameters
Item
7. subjects must have the following laboratory parameters:
boolean
C0022877 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin > or = 8.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) > or = 1000 cells/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets count > or = 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 | Females & males of reproductive potential Sexually active Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Exception Sexual sterilization
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 women 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])
C4034483 (UMLS CUI [5,1])
C0241028 (UMLS CUI [5,2])
C0700589 (UMLS CUI [5,3])
C2985296 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0038288 (UMLS CUI [9,2])
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 agents | G-CSF | Therapeutic procedure Adverse effects CTCAE Grades | Recovery Absent
Item
1. subjects having received radiotherapy, immunotherapy, chemotherapy and/or biological agents like g-csf in the 4 weeks prior to day 1 of study drug administration or have not recovered (grade < or = 1) from adverse effects of such therapy received prior to 4 weeks
boolean
C1522449 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0005515 (UMLS CUI [4])
C0079459 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C0879626 (UMLS CUI [6,2])
C1516728 (UMLS CUI [6,3])
C2004454 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Investigational New Drugs | Investigational New Drugs Adverse effects | Recovery Absent
Item
2. subjects having received any other investigational agents within 4 weeks prior to the date of enrolment or have not recovered from adverse effects of the investigational agent received prior to 4 weeks.
boolean
C0013230 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C2004454 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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 Cancer Other 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])
C1707251 (UMLS CUI [7,2])
C0012634 (UMLS CUI [7,3])
C0332296 (UMLS CUI [7,4])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Cardiac ejection fraction | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
6. subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, 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])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (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 | Medical History HIV Infection | HIV Infection Physical Examination
Item
8. subjects known to be seropositive for the human immunodeficiency virus or any history or evidence from physical examination of hiv infection.
boolean
C0019699 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0019693 (UMLS CUI [2,2])
C0019693 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
Concomitant Agent Causing Prolonged QT interval | Concomitant Agent Causing Prolonged QTc interval | Concomitant Agent 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
C2347852 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C1560305 (UMLS CUI [2,3])
C2347852 (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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