ID

30839

Beschreibung

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00507442

Link

https://clinicaltrials.gov/show/NCT00507442

Stichworte

Versionen (1)
  1. 25.06.18 25.06.18 -
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See clinicaltrials.gov

Hochgeladen am

25. Juni 2018

DOI

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Eligibility Multiple Myeloma NCT00507442

Englisch

Eligibility Multiple Myeloma NCT00507442

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
voluntary written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
male or female subject 18 years of age or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
a karnofsky performance status score of ≥50% (eastern cooperative oncology group performance status score ≤2)
Beschreibung

Karnofsky Performance Status | ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage
Beschreibung

Myeloma Symptomatic | Asymptomatic myeloma Relationship Organ damage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C2585107
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0178784
UMLS CUI [2,4]
C0010957
diagnosed multiple myeloma
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
subjects must have measurable disease requiring systemic therapy
Beschreibung

Measurable Disease Requirement Systemic therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
subjects must not have been treated previously with any systemic therapy for multiple myeloma
Beschreibung

Absence Systemic therapy Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C0026764
two weeks must have elapsed since the date of the last radiotherapy treatment
Beschreibung

Elapsed Time Since Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C1522449
women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 to 14 days prior to therapy and repeated within 24 hours before starting study drug. they must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of revlimid treatment. women must also agree to ongoing pregnancy testing
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity | Revlimid | Childbearing Potential Pregnancy Tests

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
UMLS CUI [5]
C1135145
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0032976
men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential
Beschreibung

Gender Reproduction Absent | Gender Use of Latex condom | Gender Vasectomy | Relationship Partner Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0035150
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C3873750
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0042387
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C3831118
all subjects must agree to comply with the requirements of the revassistsm program
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of allergy to any of the study medications, their analogues, or excipients in the various formulations
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Investigational New Drug Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0243071
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C0015237
≥grade 2 peripheral neuropathy on clinical examination
Beschreibung

Peripheral Neuropathy CTCAE Grades Clinical examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [1,3]
C1456356
myocardial infarction within 6 months prior to enrollment or new york heart association class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities.
Beschreibung

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
UMLS CUI [6,1]
C0151236
UMLS CUI [6,2]
C1623258
female subject who is pregnant or breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
clinically relevant active infection or serious comorbid medical conditions
Beschreibung

Communicable Disease | Comorbidity Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
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. this includes but is not limited to serious medical or psychiatric illness likely to interfere with participation in this clinical study
Beschreibung

Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status

Datentyp

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
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C3841614
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
active prior malignancy diagnosed or treated within the last 3 years
Beschreibung

Malignant Neoplasms Previous | Malignant Neoplasms Previous Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C1522326
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00507442

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
voluntary written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
male or female subject 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status | ECOG performance status
Item
a karnofsky performance status score of ≥50% (eastern cooperative oncology group performance status score ≤2)
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Myeloma Symptomatic | Asymptomatic myeloma Relationship Organ damage
Item
subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2585107 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0178784 (UMLS CUI [2,3])
C0010957 (UMLS CUI [2,4])
Multiple Myeloma
Item
diagnosed multiple myeloma
boolean
C0026764 (UMLS CUI [1])
Measurable Disease Requirement Systemic therapy
Item
subjects must have measurable disease requiring systemic therapy
boolean
C1513041 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Absence Systemic therapy Multiple Myeloma
Item
subjects must not have been treated previously with any systemic therapy for multiple myeloma
boolean
C0332197 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Elapsed Time Since Therapeutic radiology procedure
Item
two weeks must have elapsed since the date of the last radiotherapy treatment
boolean
C2826303 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity | Revlimid | Childbearing Potential Pregnancy Tests
Item
women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 to 14 days prior to therapy and repeated within 24 hours before starting study drug. they must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of revlimid treatment. women must also agree to ongoing pregnancy testing
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C1135145 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0032976 (UMLS CUI [6,2])
Gender Reproduction Absent | Gender Use of Latex condom | Gender Vasectomy | Relationship Partner Childbearing Potential
Item
men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential
boolean
C0079399 (UMLS CUI [1,1])
C0035150 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C3873750 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0042387 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C3831118 (UMLS CUI [4,3])
Protocol Compliance
Item
all subjects must agree to comply with the requirements of the revassistsm program
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Investigational New Drug Excipient
Item
history of allergy to any of the study medications, their analogues, or excipients in the various formulations
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0243071 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Peripheral Neuropathy CTCAE Grades Clinical examination
Item
≥grade 2 peripheral neuropathy on clinical examination
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Conduction system abnormalities Electrocardiography
Item
myocardial infarction within 6 months prior to enrollment or new york heart association class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or clinically significant conduction system abnormalities.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C0151236 (UMLS CUI [6,1])
C1623258 (UMLS CUI [6,2])
Pregnancy | Breast Feeding
Item
female subject who is pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Disease | Comorbidity Serious
Item
clinically relevant active infection or serious comorbid medical conditions
boolean
C0009450 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status
Item
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. this includes but is not limited to serious medical or psychiatric illness likely to interfere with participation in this clinical 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])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3841614 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Malignant Neoplasms Previous | Malignant Neoplasms Previous Treated
Item
active prior malignancy diagnosed or treated within the last 3 years
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
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