ID

30882

Beskrivning

Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01002703

Länk

https://clinicaltrials.gov/show/NCT01002703

Nyckelord

Versioner (1)
  1. 2018-07-01 2018-07-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01002703

Engelsk

Eligibility Multiple Myeloma NCT01002703

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Informed Consent

Datatyp

boolean

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. life expectancy of at least 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
4. able to adhere to the study visit schedule and other protocol requirements
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
5. relapsed or refractory mm (only first or second relapse) in stage ii or iii after autologous sct or conventional chemotherapy (histologically or cytologically proven/
Beskrivning

Recurrent multiple myeloma Durie/Salmon Stage | Refractory multiple myeloma Durie/Salmon Stage | First Relapse | Relapse second | Status post Transplantation of autologous hematopoietic stem cell | Status post Chemotherapy conventional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1370446
UMLS CUI [1,2]
C4528204
UMLS CUI [2,1]
C0278620
UMLS CUI [2,2]
C4528204
UMLS CUI [3]
C4054953
UMLS CUI [4,1]
C0035020
UMLS CUI [4,2]
C0205436
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C1831743
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C0392920
UMLS CUI [6,3]
C0439858
salmon and durie criteria) with detectable myeloma protein in blood or urine
Beskrivning

Myeloma Protein In Blood Detectable | Myeloma Protein In Urine Detectable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027015
UMLS CUI [1,2]
C0005768
UMLS CUI [1,3]
C3830527
UMLS CUI [2,1]
C0027015
UMLS CUI [2,2]
C0042037
UMLS CUI [2,3]
C3830527
6. all previous cancer therapies, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy.
Beskrivning

Cancer treatment Discontinued | Therapeutic radiology procedure Discontinued | Therapeutic procedure Cytostatic Discontinued | Operative Surgical Procedures Discontinued | Exception Steroid therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0010858
UMLS CUI [3,3]
C1444662
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C1444662
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0149783
7. ecog performance status of £ 2 at study entry (see appendix 01).
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. laboratory test results within ranges
Beskrivning

Laboratory Results Within reference range

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0460094
9. females of childbearing potential must agree to contraception or abstinence
Beskrivning

Childbearing Potential Contraceptive methods | Childbearing Potential Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
10. disease free of prior malignancies for ³ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
Beskrivning

Malignant Neoplasms Free of | 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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332296
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
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent

Datatyp

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
2. pregnant or breast feeding females.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Beskrivning

Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data

Datatyp

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]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0681873
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0681873
4. patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
Beskrivning

Medical contraindication Lenalidomide | Medical contraindication Bendamustine | Medical contraindication Prednisone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1144149
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0525079
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0032952
5. uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, new york heart association class iii or iv heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ lown 3).
Beskrivning

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled Grade | Other Coding

Datatyp

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 [5,1]
C0002962
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0085612
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0205318
UMLS CUI [6,4]
C0441800
UMLS CUI [7]
C3846158
6. use of any other experimental drug or therapy within 28 days of baseline.
Beskrivning

Investigational New Drugs | Therapies, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
7. known hypersensitivity to thalidomide or purine analogues
Beskrivning

Hypersensitivity Thalidomide | Hypersensitivity Purine analog

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1268902
8. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Beskrivning

Erythema Nodosum Development | Rash desquamating | Thalidomide | Pharmaceutical Preparations Thalidomide Similar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0014743
UMLS CUI [1,2]
C0243107
UMLS CUI [2]
C0542171
UMLS CUI [3]
C0039736
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0039736
UMLS CUI [4,3]
C2348205
9. any prior use of lenalidomide or bendamustine in the last six months
Beskrivning

lenalidomide | bendamustine

Datatyp

boolean

Alias
UMLS CUI [1]
C1144149
UMLS CUI [2]
C0525079
10. concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
Beskrivning

Antineoplastic Agents Exception Treatment Plan | Cancer treatment Exception Treatment Plan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0599880
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1705847
UMLS CUI [2,3]
C0599880
11. known positive for hiv or infectious hepatitis, type a, b or c.
Beskrivning

HIV Seropositivity | Hepatitis A positive | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112370
UMLS CUI [3]
C0856706
UMLS CUI [4]
C1112419
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Similar models

Eligibility Multiple Myeloma NCT01002703

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Life Expectancy
Item
3. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Protocol Compliance
Item
4. able to adhere to the study visit schedule and other protocol requirements
boolean
C0525058 (UMLS CUI [1])
Recurrent multiple myeloma Durie/Salmon Stage | Refractory multiple myeloma Durie/Salmon Stage | First Relapse | Relapse second | Status post Transplantation of autologous hematopoietic stem cell | Status post Chemotherapy conventional
Item
5. relapsed or refractory mm (only first or second relapse) in stage ii or iii after autologous sct or conventional chemotherapy (histologically or cytologically proven/
boolean
C1370446 (UMLS CUI [1,1])
C4528204 (UMLS CUI [1,2])
C0278620 (UMLS CUI [2,1])
C4528204 (UMLS CUI [2,2])
C4054953 (UMLS CUI [3])
C0035020 (UMLS CUI [4,1])
C0205436 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C1831743 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C0392920 (UMLS CUI [6,2])
C0439858 (UMLS CUI [6,3])
Myeloma Protein In Blood Detectable | Myeloma Protein In Urine Detectable
Item
salmon and durie criteria) with detectable myeloma protein in blood or urine
boolean
C0027015 (UMLS CUI [1,1])
C0005768 (UMLS CUI [1,2])
C3830527 (UMLS CUI [1,3])
C0027015 (UMLS CUI [2,1])
C0042037 (UMLS CUI [2,2])
C3830527 (UMLS CUI [2,3])
Cancer treatment Discontinued | Therapeutic radiology procedure Discontinued | Therapeutic procedure Cytostatic Discontinued | Operative Surgical Procedures Discontinued | Exception Steroid therapy
Item
6. all previous cancer therapies, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy.
boolean
C0920425 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0010858 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0149783 (UMLS CUI [5,2])
ECOG performance status
Item
7. ecog performance status of £ 2 at study entry (see appendix 01).
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Within reference range
Item
8. laboratory test results within ranges
boolean
C1254595 (UMLS CUI [1,1])
C0460094 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods | Childbearing Potential Sexual Abstinence
Item
9. females of childbearing potential must agree to contraception or abstinence
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
Malignant Neoplasms Free of | 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
Item
10. disease free of prior malignancies for ³ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
boolean
C0006826 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
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])
Item Group
C0680251 (UMLS CUI)
Medical condition Serious Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
1. any serious medical condition, laboratory abnormality, 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])
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])
Pregnancy | Breast Feeding
Item
2. pregnant or breast feeding females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data
Item
3. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from 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])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0681873 (UMLS CUI [3,4])
C0438215 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0681873 (UMLS CUI [4,4])
Medical contraindication Lenalidomide | Medical contraindication Bendamustine | Medical contraindication Prednisone
Item
4. patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
boolean
C1301624 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0525079 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0032952 (UMLS CUI [3,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled Grade | Other Coding
Item
5. uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, new york heart association class iii or iv heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ lown 3).
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])
C0002962 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0085612 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
C0441800 (UMLS CUI [6,4])
C3846158 (UMLS CUI [7])
Investigational New Drugs | Therapies, Investigational
Item
6. use of any other experimental drug or therapy within 28 days of baseline.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hypersensitivity Thalidomide | Hypersensitivity Purine analog
Item
7. known hypersensitivity to thalidomide or purine analogues
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1268902 (UMLS CUI [2,2])
Erythema Nodosum Development | Rash desquamating | Thalidomide | Pharmaceutical Preparations Thalidomide Similar
Item
8. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
boolean
C0014743 (UMLS CUI [1,1])
C0243107 (UMLS CUI [1,2])
C0542171 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0039736 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
lenalidomide | bendamustine
Item
9. any prior use of lenalidomide or bendamustine in the last six months
boolean
C1144149 (UMLS CUI [1])
C0525079 (UMLS CUI [2])
Antineoplastic Agents Exception Treatment Plan | Cancer treatment Exception Treatment Plan
Item
10. concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
boolean
C0003392 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0599880 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C1705847 (UMLS CUI [2,2])
C0599880 (UMLS CUI [2,3])
HIV Seropositivity | Hepatitis A positive | Hepatitis B positive | Hepatitis C positive
Item
11. known positive for hiv or infectious hepatitis, type a, b or c.
boolean
C0019699 (UMLS CUI [1])
C1112370 (UMLS CUI [2])
C0856706 (UMLS CUI [3])
C1112419 (UMLS CUI [4])
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