ID

30999

Description

Lenalidomide, Thalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00966693

Link

https://clinicaltrials.gov/show/NCT00966693

Keywords

Versions (1)
  1. 7/9/18 7/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 9, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Myeloma NCT00966693

English

Eligibility Myeloma NCT00966693

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Myeloma NCT00966693
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. understand and voluntarily sign an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. age >/= 18 years at the time of signing the informed consent form.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. relapsed/refractory mmm with measurable levels of myeloma paraprotein in serum ( >/= 0.5 g/dl), urine ( >/= 0.2 g excreted in a 24-hour collection sample), or abnormal free light chain (flc) ratio.
Description

Recurrent multiple myeloma | Refractory multiple myeloma | Serum M Protein Measurement | Urine M Protein Measurement 24 hour urine sample | Serum Immunoglobulin Free Light Chain Ratio Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2]
C0278620
UMLS CUI [3,1]
C0229671
UMLS CUI [3,2]
C0700271
UMLS CUI [3,3]
C0242485
UMLS CUI [4,1]
C0042036
UMLS CUI [4,2]
C0700271
UMLS CUI [4,3]
C0242485
UMLS CUI [4,4]
C0456209
UMLS CUI [5]
C2826181
4. serum creatinine </= 2.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. females of childbearing potential (fcbp)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlu/ml within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional affective method at the same time, at least 28 days before she starts taking lenalidomide.
Description

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

Data type

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
6. continuation from inclusion # 6: fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
Description

Childbearing Potential Pregnancy Tests | Gender Latex condom Coitus Childbearing Potential | Vasectomy | Counseling Contraceptive methods | Counseling Risk Fetal exposure

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032976
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3873750
UMLS CUI [2,3]
C0009253
UMLS CUI [2,4]
C3831118
UMLS CUI [3]
C0042387
UMLS CUI [4,1]
C0010210
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0010210
UMLS CUI [5,2]
C0035647
UMLS CUI [5,3]
C0871747
7. continuation from inclusion # 7: * a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Description

Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0020699
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0278321
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0232970
UMLS CUI [4,2]
C0332197
8. laboratory test results within these ranges: absolute neutrophil count > 1000 cells/mm^3 platelet count > 50,000 cells/mm^3 for patients with < 50% of bone marrow plasma cells and platelet count > 25,000 cells/mm^3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells total bilirubin </= 2.0 mg/dl ast (sgot) and alt (agpt) < 3 x uln
Description

Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Bone marrow plasma cells Percentage | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C2238293
UMLS CUI [4,2]
C0439165
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
9. able to take prophylactic anticoagulation, warfarin or equivalent agent
Description

Anticoagulation Prophylactic | Warfarin | Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0199176
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0205163
10. patient is able to understand and comply with the terms and conditions of the lenalidomide and thalidomide counseling program
Description

Counseling Compliance behavior | Lenalidomide | Thalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C0010210
UMLS CUI [1,2]
C1321605
UMLS CUI [2]
C1144149
UMLS CUI [3]
C0039736
11. all study participants must be registered into the mandatory revassist® program, and be willing and able to comply with the requirements of revassist®, and the s.t.e.p.s.® program.
Description

Protocol Compliance | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any serious medical condition, or psychiatric illness that would prevent the subject from signing the informed consent form
Description

Medical condition Serious Preventing Informed Consent | Serious mental illness Preventing Informed Consent

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]
C3841614
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
2. pregnant or breast feeding females. (lactating females must agree not to breast feed while taking lenalidomide).
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. use of any cancer therapy within 21 days prior to beginning cycle 1 day 1 of therapy (radiation therapy allowed within 5 days of completion of radiation therapy).
Description

Cancer treatment | Therapeutic radiology procedure Duration allowed

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0683607
4. known hypersensitivity to thalidomide, lenalidomide and dexamethasone.
Description

Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide | Dexamethasone allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1144149
UMLS CUI [3]
C0571611
5. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Description

Erythema Nodosum Associated with Rash desquamating | Intake Thalidomide | Intake Pharmaceutical Preparations Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C0014743
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0542171
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0039736
UMLS CUI [3,1]
C1512806
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C2348205
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Similar models

Eligibility Myeloma NCT00966693

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Myeloma NCT00966693
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age >/= 18 years at the time of signing the informed consent form.
boolean
C0001779 (UMLS CUI [1])
Recurrent multiple myeloma | Refractory multiple myeloma | Serum M Protein Measurement | Urine M Protein Measurement 24 hour urine sample | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
3. relapsed/refractory mmm with measurable levels of myeloma paraprotein in serum ( >/= 0.5 g/dl), urine ( >/= 0.2 g excreted in a 24-hour collection sample), or abnormal free light chain (flc) ratio.
boolean
C1370446 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
C0229671 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0242485 (UMLS CUI [3,3])
C0042036 (UMLS CUI [4,1])
C0700271 (UMLS CUI [4,2])
C0242485 (UMLS CUI [4,3])
C0456209 (UMLS CUI [4,4])
C2826181 (UMLS CUI [5])
Creatinine measurement, serum
Item
4. serum creatinine </= 2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity
Item
5. females of childbearing potential (fcbp)* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlu/ml within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional affective method at the same time, at least 28 days before she starts taking lenalidomide.
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])
Childbearing Potential Pregnancy Tests | Gender Latex condom Coitus Childbearing Potential | Vasectomy | Counseling Contraceptive methods | Counseling Risk Fetal exposure
Item
6. continuation from inclusion # 6: fcbp must also agree to ongoing pregnancy testing. men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C3873750 (UMLS CUI [2,2])
C0009253 (UMLS CUI [2,3])
C3831118 (UMLS CUI [2,4])
C0042387 (UMLS CUI [3])
C0010210 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0010210 (UMLS CUI [5,1])
C0035647 (UMLS CUI [5,2])
C0871747 (UMLS CUI [5,3])
Childbearing Potential | Hysterectomy Absent | Bilateral oophorectomy Absent | Postmenopausal state Absent
Item
7. continuation from inclusion # 7: * a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
boolean
C3831118 (UMLS CUI [1])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Bone marrow plasma cells Percentage | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
8. laboratory test results within these ranges: absolute neutrophil count > 1000 cells/mm^3 platelet count > 50,000 cells/mm^3 for patients with < 50% of bone marrow plasma cells and platelet count > 25,000 cells/mm^3 for patients in whom > 50% of the bone marrow nucleated cells were plasma cells total bilirubin </= 2.0 mg/dl ast (sgot) and alt (agpt) < 3 x uln
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C2238293 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
Anticoagulation Prophylactic | Warfarin | Equivalent
Item
9. able to take prophylactic anticoagulation, warfarin or equivalent agent
boolean
C0003281 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0043031 (UMLS CUI [2])
C0205163 (UMLS CUI [3])
Counseling Compliance behavior | Lenalidomide | Thalidomide
Item
10. patient is able to understand and comply with the terms and conditions of the lenalidomide and thalidomide counseling program
boolean
C0010210 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1144149 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
Protocol Compliance | Other Coding
Item
11. all study participants must be registered into the mandatory revassist® program, and be willing and able to comply with the requirements of revassist®, and the s.t.e.p.s.® program.
boolean
C0525058 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious Preventing Informed Consent | Serious mental illness Preventing Informed Consent
Item
1. any serious medical condition, or psychiatric illness that would prevent the subject from signing the informed consent form
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
2. pregnant or breast feeding females. (lactating females must agree not to breast feed while taking lenalidomide).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer treatment | Therapeutic radiology procedure Duration allowed
Item
3. use of any cancer therapy within 21 days prior to beginning cycle 1 day 1 of therapy (radiation therapy allowed within 5 days of completion of radiation therapy).
boolean
C0920425 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide | Dexamethasone allergy
Item
4. known hypersensitivity to thalidomide, lenalidomide and dexamethasone.
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1144149 (UMLS CUI [2,2])
C0571611 (UMLS CUI [3])
Erythema Nodosum Associated with Rash desquamating | Intake Thalidomide | Intake Pharmaceutical Preparations Similar
Item
5. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
C0014743 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0542171 (UMLS CUI [1,3])
C1512806 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C1512806 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
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