ID

30891

Description

Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01160107

Link

https://clinicaltrials.gov/show/NCT01160107

Keywords

Versions (1)
  1. 7/2/18 7/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01160107

English

Eligibility Multiple Myeloma NCT01160107

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 65 years of age or older at the time of signing the informed consent.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
Description

Gender Contraceptive methods | Condoms, Male | Sexual Abstinence | Lenalidomide Discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009653
UMLS CUI [3]
C0036899
UMLS CUI [4,1]
C1144149
UMLS CUI [4,2]
C1444662
female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(highly effective methods: intrauterine device -iud-; hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; additional effective methods: latex condom; diaphragm; cervical cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
Description

Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Contraceptive methods Double | Intrauterine Devices | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant | Tubal Ligation | Partner had vasectomy | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Lenalidomide Discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0205173
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0009907
UMLS CUI [7]
C1656586
UMLS CUI [8]
C1657106
UMLS CUI [9]
C0520483
UMLS CUI [10]
C0420842
UMLS CUI [11]
C3873750
UMLS CUI [12]
C0042241
UMLS CUI [13]
C0493327
UMLS CUI [14,1]
C1144149
UMLS CUI [14,2]
C1444662
patient was a newly diagnosed multiple myeloma based on standard criteria
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
patient has measurable disease, defined as follows: - secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dl of igg m-protein and greater than 0.5 g/dl of iga m-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; - non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., mri or ct scan).
Description

Measurable Disease | Multiple Myeloma | Serum M Protein Measurement | M Protein Immunoglobulin G measurement | M Protein Immunoglobulin A measurement | Urine light chain measurement 24 Hour Test | Non-secretory myeloma | Plasma Cells Bone marrow Percentage | Plasmacytoma Size Quantity Clinical examination | Plasmacytoma Size Quantity Radiography | Plasmacytoma Size Quantity MRI | Plasmacytoma Size Quantity CT scan

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0026764
UMLS CUI [3,1]
C0229671
UMLS CUI [3,2]
C0700271
UMLS CUI [3,3]
C0242485
UMLS CUI [4,1]
C0700271
UMLS CUI [4,2]
C0202087
UMLS CUI [5,1]
C0700271
UMLS CUI [5,2]
C0202083
UMLS CUI [6,1]
C1445962
UMLS CUI [6,2]
C1255149
UMLS CUI [7]
C0456845
UMLS CUI [8,1]
C1994776
UMLS CUI [8,2]
C0439165
UMLS CUI [9,1]
C0032131
UMLS CUI [9,2]
C0456389
UMLS CUI [9,3]
C1265611
UMLS CUI [9,4]
C1456356
UMLS CUI [10,1]
C0032131
UMLS CUI [10,2]
C0456389
UMLS CUI [10,3]
C1265611
UMLS CUI [10,4]
C0034571
UMLS CUI [11,1]
C0032131
UMLS CUI [11,2]
C0456389
UMLS CUI [11,3]
C1265611
UMLS CUI [11,4]
C0024485
UMLS CUI [12,1]
C0032131
UMLS CUI [12,2]
C0456389
UMLS CUI [12,3]
C1265611
UMLS CUI [12,4]
C0040405
patient has a karnofsky performance status ≥ 50%.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patient has a life-expectancy >3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
Description

Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent | Medical condition Serious Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C2348568
UMLS CUI [4,4]
C1444641
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1444641
previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days).
Description

Prior Therapy Multiple Myeloma | Exception Therapeutic radiology procedure | Exception Diphosphonates | Exception Steroids Dosage | Equivalent Dexamethasone U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012544
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C0178602
UMLS CUI [5,1]
C0205163
UMLS CUI [5,2]
C0011777
UMLS CUI [5,3]
C0456683
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known positive for hiv or active infectious hepatitis type a, b or c
Description

HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019159
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
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Similar models

Eligibility Multiple Myeloma NCT01160107

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 65 years of age or older at the time of signing the informed consent.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
boolean
C0021430 (UMLS CUI [1])
Gender Contraceptive methods | Condoms, Male | Sexual Abstinence | Lenalidomide Discontinuation
Item
male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009653 (UMLS CUI [2])
C0036899 (UMLS CUI [3])
C1144149 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Contraceptive methods Double | Intrauterine Devices | Contraceptives, Oral, Hormonal | Contraceptive injection | Contraceptive implant | Tubal Ligation | Partner had vasectomy | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Lenalidomide Discontinuation
Item
female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(highly effective methods: intrauterine device -iud-; hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; additional effective methods: latex condom; diaphragm; cervical cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0205173 (UMLS CUI [4,3])
C0021900 (UMLS CUI [5])
C0009907 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C0520483 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C3873750 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
C0493327 (UMLS CUI [13])
C1144149 (UMLS CUI [14,1])
C1444662 (UMLS CUI [14,2])
Multiple Myeloma
Item
patient was a newly diagnosed multiple myeloma based on standard criteria
boolean
C0026764 (UMLS CUI [1])
Measurable Disease | Multiple Myeloma | Serum M Protein Measurement | M Protein Immunoglobulin G measurement | M Protein Immunoglobulin A measurement | Urine light chain measurement 24 Hour Test | Non-secretory myeloma | Plasma Cells Bone marrow Percentage | Plasmacytoma Size Quantity Clinical examination | Plasmacytoma Size Quantity Radiography | Plasmacytoma Size Quantity MRI | Plasmacytoma Size Quantity CT scan
Item
patient has measurable disease, defined as follows: - secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dl of igg m-protein and greater than 0.5 g/dl of iga m-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; - non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., mri or ct scan).
boolean
C1513041 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0229671 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0242485 (UMLS CUI [3,3])
C0700271 (UMLS CUI [4,1])
C0202087 (UMLS CUI [4,2])
C0700271 (UMLS CUI [5,1])
C0202083 (UMLS CUI [5,2])
C1445962 (UMLS CUI [6,1])
C1255149 (UMLS CUI [6,2])
C0456845 (UMLS CUI [7])
C1994776 (UMLS CUI [8,1])
C0439165 (UMLS CUI [8,2])
C0032131 (UMLS CUI [9,1])
C0456389 (UMLS CUI [9,2])
C1265611 (UMLS CUI [9,3])
C1456356 (UMLS CUI [9,4])
C0032131 (UMLS CUI [10,1])
C0456389 (UMLS CUI [10,2])
C1265611 (UMLS CUI [10,3])
C0034571 (UMLS CUI [10,4])
C0032131 (UMLS CUI [11,1])
C0456389 (UMLS CUI [11,2])
C1265611 (UMLS CUI [11,3])
C0024485 (UMLS CUI [11,4])
C0032131 (UMLS CUI [12,1])
C0456389 (UMLS CUI [12,2])
C1265611 (UMLS CUI [12,3])
C0040405 (UMLS CUI [12,4])
Karnofsky Performance Status
Item
patient has a karnofsky performance status ≥ 50%.
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
patient has a life-expectancy >3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent | Medical condition Serious Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Mental disorders Study Subject Participation Status At risk
Item
any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C1444641 (UMLS CUI [4,4])
C0438215 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
Prior Therapy Multiple Myeloma | Exception Therapeutic radiology procedure | Exception Diphosphonates | Exception Steroids Dosage | Equivalent Dexamethasone U/day
Item
previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days).
boolean
C1514463 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012544 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205163 (UMLS CUI [5,1])
C0011777 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C
Item
known positive for hiv or active infectious hepatitis type a, b or c
boolean
C0019699 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
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