ID

21962

Description

An Efficacy and Safety Study of Bortezomib Re-treatment in Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00431769

Link

https://clinicaltrials.gov/show/NCT00431769

Keywords

Versions (1)
  1. 5/10/17 5/10/17 -
Uploaded on

May 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00431769

English

Eligibility Multiple Myeloma NCT00431769

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant was previously diagnosed with multiple myeloma based on standard criteria and had measurable disease. measurable disease for secretory multiple myeloma was defined as any quantifiable serum m-protein value (generally, but not exclusively, greater than (>) 1 gram per deciliter (g/dl) immunoglobulin (ig) g myeloma protein (m-protein) and >0.5 g/dl ig a) or urine light-chain excretion of equal to (=) or >200 milligram (mg)/24 hour
Description

Multiple Myeloma | Measurable Disease | Multiple Myeloma Secretion | Serum M Protein Immunoglobulin G measurement | M Protein Immunoglobulin A measurement | Urine light chain measurement Unit per 24 Hours

Data type

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1513041
UMLS CUI [3,1]
C0026764
UMLS CUI [3,2]
C1327616
UMLS CUI [4,1]
C0229671
UMLS CUI [4,2]
C0700271
UMLS CUI [4,3]
C0202087
UMLS CUI [5,1]
C0700271
UMLS CUI [5,2]
C0202083
UMLS CUI [6,1]
C1445962
UMLS CUI [6,2]
C1883460
participant previously tolerated 1.0 or 1.3 mg/metersquare (m^2) bortezomib alone or in combination with other agents and had complete response (cr) or partial response (pr) upon completion of bortezomib therapy
Description

bortezomib | Combined Modality Therapy | In complete remission | partial response

Data type

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0677874
UMLS CUI [4]
C1521726
it had been greater than or equal to (>=) 6 months since the participant's last bortezomibdose and the participant had progressive disease (pd) if prior response to bortezomib was pr or the participant had relapsed from cr
Description

Bortezomib Dosage | partial response | In complete remission | Recurrent disease | Progressive Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1176309
UMLS CUI [1,2]
C0178602
UMLS CUI [2]
C1521726
UMLS CUI [3]
C0677874
UMLS CUI [4]
C0277556
UMLS CUI [5]
C1335499
participant had a life expectancy >3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
if female, the participant was either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from screening through at least 30 days after completion of the last cycle
Description

Postmenopausal state | Female Sterilization | Gender Contraceptive methods Willing

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant had received chemotherapy, radiotherapy, antibody, immunotherapy, or experimental therapy to treat multiple myeloma since their last dose of bortezomib. note: participants could have received localized palliative radiotherapy for complications due to osteolytic bone lesions. participants could have received steroids (dexamethasone or equivalent) or thalidomide or interferon as maintenance therapy since their last dose of bortezomib according to local standard of care. in addition, participants could have received a cumulative dose of up to 160 mg dexamethasone or equivalent as emergency therapy within 4 weeks prior to enrolment. participants could have received high dose therapy/stem cell transplantation after induction regimen containing bortezomib, but only if pr or cr was observed during bortezomib containing induction therapy
Description

Chemotherapy Multiple Myeloma | Therapeutic radiology procedure Multiple Myeloma | Antibody therapy Multiple Myeloma | Immunotherapy Multiple Myeloma | Investigational Therapies Multiple Myeloma | bortezomib | Palliative course of radiotherapy OSTEOLYTIC BONE LESION Complication | Steroids | Dexamethasone | Dexamethasone Equivalent | Thalidomide | Interferon | Maintenance therapy | Dexamethasone Cumulative Dose | Dexamethasone Equivalent Cumulative Dose | Emergency treatment | Therapeutic procedure High dose | Stem cell transplant | Neoadjuvant Therapy Containing Bortezomib | partial response | In complete remission

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0026764
UMLS CUI [3,1]
C0281176
UMLS CUI [3,2]
C0026764
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C0026764
UMLS CUI [5,1]
C0949266
UMLS CUI [5,2]
C0026764
UMLS CUI [6]
C1176309
UMLS CUI [7,1]
C0475092
UMLS CUI [7,2]
C0302846
UMLS CUI [7,3]
C0009566
UMLS CUI [8]
C0038317
UMLS CUI [9]
C0011777
UMLS CUI [10,1]
C0011777
UMLS CUI [10,2]
C0205163
UMLS CUI [11]
C0039736
UMLS CUI [12]
C0733470
UMLS CUI [13]
C0677908
UMLS CUI [14,1]
C0011777
UMLS CUI [14,2]
C2986497
UMLS CUI [15,1]
C0011777
UMLS CUI [15,2]
C0205163
UMLS CUI [15,3]
C2986497
UMLS CUI [16]
C0013969
UMLS CUI [17,1]
C0087111
UMLS CUI [17,2]
C0444956
UMLS CUI [18]
C1504389
UMLS CUI [19,1]
C0600558
UMLS CUI [19,2]
C0332256
UMLS CUI [19,3]
C1176309
UMLS CUI [20]
C1521726
UMLS CUI [21]
C0677874
participant had uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment or had new york heart association class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Description

Cardiovascular Diseases Uncontrolled | Cardiovascular Diseases Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Ventricular arrhythmia Uncontrolled Severe | Ischemia Evidence Electrocardiography | Conduction system abnormalities Evidence Electrocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0421196
UMLS CUI [6]
C0265122
UMLS CUI [7,1]
C0085612
UMLS CUI [7,2]
C0205318
UMLS CUI [7,3]
C0205082
UMLS CUI [8,1]
C0022116
UMLS CUI [8,2]
C3887511
UMLS CUI [8,3]
C1623258
UMLS CUI [9,1]
C0151236
UMLS CUI [9,2]
C3887511
UMLS CUI [9,3]
C1623258
participant had poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol
Description

Uncontrolled hypertension | Diabetic - poor control | Illness Serious Interferes with Treatment completion | Mental disorder Serious Interferes with Treatment completion

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421258
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0580352
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0580352
participant had another malignancy within the past 5 years. exceptions were made for the following if they were treated and not active: basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or international federation of gynecology and obstetrics stage 1 carcinoma of the cervix
Description

Malignant Neoplasms | Basal cell carcinoma Treated Successful | Squamous cell carcinoma of skin Treated Successful | Carcinoma in situ of uterine cervix Treated Successful FIGO staging system of gynecological malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C1272703
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C1272703
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C1272703
UMLS CUI [4,4]
C0474956
patient has an uncontrolled or severe cardiovascular disease, within 6 months of enrolment
Description

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
female participant was pregnant or breast feeding. confirmation that the participant was not pregnant was to be established by a negative beta human chorionic gonadotropin pregnancy test result obtained during the screening period. pregnancy testing was not required for post menopausal or surgically sterilized women.
Description

Pregnancy | Breast Feeding | Serum pregnancy test (B-HCG) Negative | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0430060
UMLS CUI [3,2]
C1513916
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0015787
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Similar models

Eligibility Multiple Myeloma NCT00431769

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Measurable Disease | Multiple Myeloma Secretion | Serum M Protein Immunoglobulin G measurement | M Protein Immunoglobulin A measurement | Urine light chain measurement Unit per 24 Hours
Item
participant was previously diagnosed with multiple myeloma based on standard criteria and had measurable disease. measurable disease for secretory multiple myeloma was defined as any quantifiable serum m-protein value (generally, but not exclusively, greater than (>) 1 gram per deciliter (g/dl) immunoglobulin (ig) g myeloma protein (m-protein) and >0.5 g/dl ig a) or urine light-chain excretion of equal to (=) or >200 milligram (mg)/24 hour
boolean
C0026764 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0026764 (UMLS CUI [3,1])
C1327616 (UMLS CUI [3,2])
C0229671 (UMLS CUI [4,1])
C0700271 (UMLS CUI [4,2])
C0202087 (UMLS CUI [4,3])
C0700271 (UMLS CUI [5,1])
C0202083 (UMLS CUI [5,2])
C1445962 (UMLS CUI [6,1])
C1883460 (UMLS CUI [6,2])
bortezomib | Combined Modality Therapy | In complete remission | partial response
Item
participant previously tolerated 1.0 or 1.3 mg/metersquare (m^2) bortezomib alone or in combination with other agents and had complete response (cr) or partial response (pr) upon completion of bortezomib therapy
boolean
C1176309 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0677874 (UMLS CUI [3])
C1521726 (UMLS CUI [4])
Bortezomib Dosage | partial response | In complete remission | Recurrent disease | Progressive Disease
Item
it had been greater than or equal to (>=) 6 months since the participant's last bortezomibdose and the participant had progressive disease (pd) if prior response to bortezomib was pr or the participant had relapsed from cr
boolean
C1176309 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1521726 (UMLS CUI [2])
C0677874 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C1335499 (UMLS CUI [5])
Life Expectancy
Item
participant had a life expectancy >3 months
boolean
C0023671 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods Willing
Item
if female, the participant was either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from screening through at least 30 days after completion of the last cycle
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Multiple Myeloma | Therapeutic radiology procedure Multiple Myeloma | Antibody therapy Multiple Myeloma | Immunotherapy Multiple Myeloma | Investigational Therapies Multiple Myeloma | bortezomib | Palliative course of radiotherapy OSTEOLYTIC BONE LESION Complication | Steroids | Dexamethasone | Dexamethasone Equivalent | Thalidomide | Interferon | Maintenance therapy | Dexamethasone Cumulative Dose | Dexamethasone Equivalent Cumulative Dose | Emergency treatment | Therapeutic procedure High dose | Stem cell transplant | Neoadjuvant Therapy Containing Bortezomib | partial response | In complete remission
Item
participant had received chemotherapy, radiotherapy, antibody, immunotherapy, or experimental therapy to treat multiple myeloma since their last dose of bortezomib. note: participants could have received localized palliative radiotherapy for complications due to osteolytic bone lesions. participants could have received steroids (dexamethasone or equivalent) or thalidomide or interferon as maintenance therapy since their last dose of bortezomib according to local standard of care. in addition, participants could have received a cumulative dose of up to 160 mg dexamethasone or equivalent as emergency therapy within 4 weeks prior to enrolment. participants could have received high dose therapy/stem cell transplantation after induction regimen containing bortezomib, but only if pr or cr was observed during bortezomib containing induction therapy
boolean
C0392920 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0281176 (UMLS CUI [3,1])
C0026764 (UMLS CUI [3,2])
C0021083 (UMLS CUI [4,1])
C0026764 (UMLS CUI [4,2])
C0949266 (UMLS CUI [5,1])
C0026764 (UMLS CUI [5,2])
C1176309 (UMLS CUI [6])
C0475092 (UMLS CUI [7,1])
C0302846 (UMLS CUI [7,2])
C0009566 (UMLS CUI [7,3])
C0038317 (UMLS CUI [8])
C0011777 (UMLS CUI [9])
C0011777 (UMLS CUI [10,1])
C0205163 (UMLS CUI [10,2])
C0039736 (UMLS CUI [11])
C0733470 (UMLS CUI [12])
C0677908 (UMLS CUI [13])
C0011777 (UMLS CUI [14,1])
C2986497 (UMLS CUI [14,2])
C0011777 (UMLS CUI [15,1])
C0205163 (UMLS CUI [15,2])
C2986497 (UMLS CUI [15,3])
C0013969 (UMLS CUI [16])
C0087111 (UMLS CUI [17,1])
C0444956 (UMLS CUI [17,2])
C1504389 (UMLS CUI [18])
C0600558 (UMLS CUI [19,1])
C0332256 (UMLS CUI [19,2])
C1176309 (UMLS CUI [19,3])
C1521726 (UMLS CUI [20])
C0677874 (UMLS CUI [21])
Cardiovascular Diseases Uncontrolled | Cardiovascular Diseases Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Ventricular arrhythmia Uncontrolled Severe | Ischemia Evidence Electrocardiography | Conduction system abnormalities Evidence Electrocardiography
Item
participant had uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment or had new york heart association class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0421196 (UMLS CUI [5])
C0265122 (UMLS CUI [6])
C0085612 (UMLS CUI [7,1])
C0205318 (UMLS CUI [7,2])
C0205082 (UMLS CUI [7,3])
C0022116 (UMLS CUI [8,1])
C3887511 (UMLS CUI [8,2])
C1623258 (UMLS CUI [8,3])
C0151236 (UMLS CUI [9,1])
C3887511 (UMLS CUI [9,2])
C1623258 (UMLS CUI [9,3])
Uncontrolled hypertension | Diabetic - poor control | Illness Serious Interferes with Treatment completion | Mental disorder Serious Interferes with Treatment completion
Item
participant had poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol
boolean
C1868885 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0580352 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0580352 (UMLS CUI [4,4])
Malignant Neoplasms | Basal cell carcinoma Treated Successful | Squamous cell carcinoma of skin Treated Successful | Carcinoma in situ of uterine cervix Treated Successful FIGO staging system of gynecological malignancy
Item
participant had another malignancy within the past 5 years. exceptions were made for the following if they were treated and not active: basal cell or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or international federation of gynecology and obstetrics stage 1 carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1272703 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C1272703 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C1272703 (UMLS CUI [4,3])
C0474956 (UMLS CUI [4,4])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe
Item
patient has an uncontrolled or severe cardiovascular disease, within 6 months of enrolment
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Serum pregnancy test (B-HCG) Negative | Postmenopausal state | Female Sterilization
Item
female participant was pregnant or breast feeding. confirmation that the participant was not pregnant was to be established by a negative beta human chorionic gonadotropin pregnancy test result obtained during the screening period. pregnancy testing was not required for post menopausal or surgically sterilized women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430060 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
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