ID

36420

Descripción

Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02289222

Link

https://clinicaltrials.gov/show/NCT02289222

Palabras clave

Versiones (1)
  1. 13/5/19 13/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02289222

Inglés

Eligibility Multiple Myeloma NCT02289222

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of relapsed and/or refractory mm according to international myeloma working group guidelines (2003)
Descripción

Recurrent multiple myeloma | Multiple myeloma Refractory

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0205269
2. documented disease progression during or within 60 days after their most recent line of anti-myeloma therapy.
Descripción

Disease Progression | Therapeutic procedure Myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0026764
3. failure of 2 lines of prior therapy that includes an imid (lenalidomide or thalidomide) and a proteasome inhibitor (bortezomib and/or carfilzomib) (used either separately or in combination).
Descripción

Prior Therapy Quantity failed | Immunomodulators | lenalidomide | Thalidomide | Proteasome inhibitor | bortezomib | carfilzomib | Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2]
C1527392
UMLS CUI [3]
C1144149
UMLS CUI [4]
C0039736
UMLS CUI [5]
C1443643
UMLS CUI [6]
C1176309
UMLS CUI [7]
C2001856
UMLS CUI [8]
C0009429
4. measurable disease as defined by the protocol.
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
5. be willing and able to provide written informed consent/assent for the trial.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
6. have a performance status of 0 1 2 on the ecog performance scale.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
7. demonstrate adequate organ function as defined by the protocol.
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
8. female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug.
Descripción

Childbearing Potential Serum pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
9. male subjects should agree to use an adequate method of contraception.
Descripción

Gender Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
Descripción

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
2. has a diagnosis of immunodeficiency (hiv) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Descripción

HIV Infection | Steroid therapy Systemic | Therapeutic immunosuppression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0021079
3. has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Descripción

Monoclonal Antibody | Adverse event Due to Pharmaceutical Preparations | Lacking Recovery CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003250
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0013227
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2004454
UMLS CUI [3,3]
C1516728
4. has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent. (subjects with
Descripción

Prior Chemotherapy | Targeted Therapy Small Molecule | Prior radiation therapy | Adverse event Due to Pharmaceutical Preparations | Lacking Recovery CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1328819
UMLS CUI [3]
C0279134
UMLS CUI [4,1]
C0877248
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0013227
UMLS CUI [5,1]
C0332268
UMLS CUI [5,2]
C2004454
UMLS CUI [5,3]
C1516728
≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.)
Descripción

Exception Neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0442874
UMLS CUI [1,3]
C1516728
5. has a known additional malignancy that is progressing or requires active treatment.
Descripción

Second Cancer Progressing | Second Cancer Treatment required for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0751623
UMLS CUI [1,2]
C0205329
UMLS CUI [2,1]
C0751623
UMLS CUI [2,2]
C0332121
6. has known active central nervous system disease and/or carcinomatous meningitis.
Descripción

CNS disorder | Meningeal Carcinomatosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0220654
7. has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
Descripción

Autoimmune Disease Requirement Systemic therapy | Autoimmune Disease Severe | Syndrome Requirement Systemic steroids | Syndrome Requirement Immunosuppressive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0039082
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C2825233
UMLS CUI [4,1]
C0039082
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0021081
8. has evidence of interstitial lung disease or active, non-infectious pneumonitis.
Descripción

Lung Diseases, Interstitial | Non-infectious pneumonia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C0264376
9. has an active infection requiring systemic therapy.
Descripción

Communicable Disease Requirement Systemic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
10. has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Descripción

Condition Interferes with Research results | Therapeutic procedure Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Condition Interferes with Study Subject Participation Status | Therapeutic procedure Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status | Condition Study Subject Participation Status Unfavorable | Therapeutic procedure Study Subject Participation Status Unfavorable | Laboratory test result abnormal Study Subject Participation Status Unfavorable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C0438215
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C3640815
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C3640815
UMLS CUI [9,1]
C0438215
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C3640815
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Similar models

Eligibility Multiple Myeloma NCT02289222

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent multiple myeloma | Multiple myeloma Refractory
Item
1. confirmed diagnosis of relapsed and/or refractory mm according to international myeloma working group guidelines (2003)
boolean
C1370446 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Disease Progression | Therapeutic procedure Myeloma
Item
2. documented disease progression during or within 60 days after their most recent line of anti-myeloma therapy.
boolean
C0242656 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
Prior Therapy Quantity failed | Immunomodulators | lenalidomide | Thalidomide | Proteasome inhibitor | bortezomib | carfilzomib | Combined Modality Therapy
Item
3. failure of 2 lines of prior therapy that includes an imid (lenalidomide or thalidomide) and a proteasome inhibitor (bortezomib and/or carfilzomib) (used either separately or in combination).
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1527392 (UMLS CUI [2])
C1144149 (UMLS CUI [3])
C0039736 (UMLS CUI [4])
C1443643 (UMLS CUI [5])
C1176309 (UMLS CUI [6])
C2001856 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
Measurable Disease
Item
4. measurable disease as defined by the protocol.
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
5. be willing and able to provide written informed consent/assent for the trial.
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
6. have a performance status of 0 1 2 on the ecog performance scale.
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
7. demonstrate adequate organ function as defined by the protocol.
boolean
C0678852 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative
Item
8. female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Gender Contraceptive methods
Item
9. male subjects should agree to use an adequate method of contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
1. is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
HIV Infection | Steroid therapy Systemic | Therapeutic immunosuppression
Item
2. has a diagnosis of immunodeficiency (hiv) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
boolean
C0019693 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0021079 (UMLS CUI [3])
Monoclonal Antibody | Adverse event Due to Pharmaceutical Preparations | Lacking Recovery CTCAE Grades
Item
3. has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
boolean
C0003250 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C2004454 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
Prior Chemotherapy | Targeted Therapy Small Molecule | Prior radiation therapy | Adverse event Due to Pharmaceutical Preparations | Lacking Recovery CTCAE Grades
Item
4. has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent. (subjects with
boolean
C1514457 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C1328819 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3])
C0877248 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0332268 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C1516728 (UMLS CUI [5,3])
Exception Neuropathy CTCAE Grades
Item
≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.)
boolean
C1705847 (UMLS CUI [1,1])
C0442874 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Second Cancer Progressing | Second Cancer Treatment required for
Item
5. has a known additional malignancy that is progressing or requires active treatment.
boolean
C0751623 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0751623 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
CNS disorder | Meningeal Carcinomatosis
Item
6. has known active central nervous system disease and/or carcinomatous meningitis.
boolean
C0007682 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Autoimmune Disease Requirement Systemic therapy | Autoimmune Disease Severe | Syndrome Requirement Systemic steroids | Syndrome Requirement Immunosuppressive Agents
Item
7. has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C0004364 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0039082 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C2825233 (UMLS CUI [3,3])
C0039082 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0021081 (UMLS CUI [4,3])
Lung Diseases, Interstitial | Non-infectious pneumonia
Item
8. has evidence of interstitial lung disease or active, non-infectious pneumonitis.
boolean
C0206062 (UMLS CUI [1])
C0264376 (UMLS CUI [2])
Communicable Disease Requirement Systemic therapy
Item
9. has an active infection requiring systemic therapy.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Condition Interferes with Research results | Therapeutic procedure Interferes with Research results | Laboratory test result abnormal Interferes with Research results | Condition Interferes with Study Subject Participation Status | Therapeutic procedure Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status | Condition Study Subject Participation Status Unfavorable | Therapeutic procedure Study Subject Participation Status Unfavorable | Laboratory test result abnormal Study Subject Participation Status Unfavorable
Item
10. has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0348080 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C3640815 (UMLS CUI [7,3])
C0087111 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C3640815 (UMLS CUI [8,3])
C0438215 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C3640815 (UMLS CUI [9,3])
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