ID

36454

Descripción

Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02462525

Link

https://clinicaltrials.gov/show/NCT02462525

Palabras clave

Versiones (1)
  1. 15/5/19 15/5/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de mayo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02462525

Inglés

Eligibility Multiple Myeloma NCT02462525

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group performance status of 0 to 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
Descripción

Ineligibility Stem cell transplant | Ineligibility Bone Marrow Transplantation | Stem cell transplant Refused | Bone Marrow Transplantation Refused | Recurrent disease Post Autologous hematopoietic stem cell transplant | Recurrent disease Post Autologous bone marrow transplant | Recurrent disease Post Allogeneic hematopoietic stem cell transplant | Recurrent disease Post Allogeneic bone marrow transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C1504389
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0005961
UMLS CUI [3,1]
C1504389
UMLS CUI [3,2]
C1705116
UMLS CUI [4,1]
C0005961
UMLS CUI [4,2]
C1705116
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C2193200
UMLS CUI [6,1]
C0277556
UMLS CUI [6,2]
C0687676
UMLS CUI [6,3]
C0194037
UMLS CUI [7,1]
C0277556
UMLS CUI [7,2]
C0687676
UMLS CUI [7,3]
C4255274
UMLS CUI [8,1]
C0277556
UMLS CUI [8,2]
C0687676
UMLS CUI [8,3]
C0149615
eligible for and agree to bm aspirate prior to treatment start
Descripción

Eligibility Bone marrow aspirate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1271729
measurable disease m component in serum (≥ 0.5 g/dl) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
Descripción

Measurable Disease | M Protein Measurement Serum | M Protein Measurement In Urine 24 hour urine sample

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C2984963
UMLS CUI [2,2]
C0229671
UMLS CUI [3,1]
C2984963
UMLS CUI [3,2]
C0042037
UMLS CUI [3,3]
C0456209
received at least 2 prior therapies including an imid and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an imid or proteasome inhibitor, are allowed to enroll in the trial
Descripción

Prior Therapy Quantity | Immunomodulators | Proteasome inhibitor | Disease Progression | Alkylating Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1527392
UMLS CUI [3]
C1443643
UMLS CUI [4]
C0242656
UMLS CUI [5]
C0002073
participants must have adequate liver, kidney, and bone morrow function
Descripción

Liver function | Renal function | Bone Marrow function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
participants with a history of chronic heart failure must have cardiac echo indicating left ventricular ejection fraction (lvef) ≥ 45% within 21 days prior to first dose of study drug
Descripción

Chronic heart failure | Left ventricular ejection fraction Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0264716
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, or any investigational therapy within a period of 21 days, herbal therapy within 7 days prior to the first dose of abbv-838, and have unresolved toxicities ≥
Descripción

Cancer treatment | Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Biological treatment | Therapy, Investigational | Phytotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1522449
UMLS CUI [5]
C1531518
UMLS CUI [6]
C0949266
UMLS CUI [7]
C0242388
grade 2
Descripción

Toxicity CTCAE Grades | Resolution Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0332268
concurrent metastatic solid tumors
Descripción

Solid Neoplasm metastatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C1522484
non-measurable m protein (serum or urine) and measurable sflc (< 100 mg/ml)
Descripción

M Protein Non-Measurable Serum | M Protein Non-Measurable In Urine | Serum Free Light Chain Measurable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700271
UMLS CUI [1,2]
C1518373
UMLS CUI [1,3]
C0229671
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C1518373
UMLS CUI [2,3]
C0042037
UMLS CUI [3,1]
C2827352
UMLS CUI [3,2]
C1513040
major surgery within 21 days prior to the first dose of abbv-838
Descripción

Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
clinically significant uncontrolled condition(s) including but not limited to the following:
Descripción

Condition Clinical Significance Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0205318
grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain uncontrolled hypercalcemia active uncontrolled infection symptomatic congestive heart failure unstable angina pectoris or cardiac arrhythmia psychiatric illness/social situation that would limit compliance with the study
Descripción

Peripheral Neuropathy CTCAE Grades | Pain | Hypercalcemia Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0030193
UMLS CUI [3,1]
C0020437
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0742758
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0003811
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
UMLS CUI [9,1]
C0748872
UMLS CUI [9,2]
C0439801
UMLS CUI [9,3]
C0525058
major immunologic reaction to any igg containing agent or auristatin based agent
Descripción

Immunologic reaction Major Immunoglobulin G | Immunologic reaction Major Auristatin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0301873
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0020852
UMLS CUI [2,1]
C0301873
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C2742798
participants who are taking strong cyp3a4 inhibitors
Descripción

CYP3A4 Inhibitors Strong

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
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Similar models

Eligibility Multiple Myeloma NCT02462525

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Ineligibility Stem cell transplant | Ineligibility Bone Marrow Transplantation | Stem cell transplant Refused | Bone Marrow Transplantation Refused | Recurrent disease Post Autologous hematopoietic stem cell transplant | Recurrent disease Post Autologous bone marrow transplant | Recurrent disease Post Allogeneic hematopoietic stem cell transplant | Recurrent disease Post Allogeneic bone marrow transplantation
Item
not eligible for stem cell/bone marrow transplant or have refused stem cell/bone marrow transplant or have relapsed after autologous or allogeneic stem cell/bone marrow transplant
boolean
C1512714 (UMLS CUI [1,1])
C1504389 (UMLS CUI [1,2])
C1512714 (UMLS CUI [2,1])
C0005961 (UMLS CUI [2,2])
C1504389 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
C0005961 (UMLS CUI [4,1])
C1705116 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C2193200 (UMLS CUI [5,3])
C0277556 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C0194037 (UMLS CUI [6,3])
C0277556 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C4255274 (UMLS CUI [7,3])
C0277556 (UMLS CUI [8,1])
C0687676 (UMLS CUI [8,2])
C0149615 (UMLS CUI [8,3])
Eligibility Bone marrow aspirate
Item
eligible for and agree to bm aspirate prior to treatment start
boolean
C1548635 (UMLS CUI [1,1])
C1271729 (UMLS CUI [1,2])
Measurable Disease | M Protein Measurement Serum | M Protein Measurement In Urine 24 hour urine sample
Item
measurable disease m component in serum (≥ 0.5 g/dl) and/or urine (≥ 0.2 g excreted in a 24 hour collection sample)
boolean
C1513041 (UMLS CUI [1])
C2984963 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
C2984963 (UMLS CUI [3,1])
C0042037 (UMLS CUI [3,2])
C0456209 (UMLS CUI [3,3])
Prior Therapy Quantity | Immunomodulators | Proteasome inhibitor | Disease Progression | Alkylating Agents
Item
received at least 2 prior therapies including an imid and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy; participants previously treated with an alkylating agent, in addition to an imid or proteasome inhibitor, are allowed to enroll in the trial
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1527392 (UMLS CUI [2])
C1443643 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C0002073 (UMLS CUI [5])
Liver function | Renal function | Bone Marrow function
Item
participants must have adequate liver, kidney, and bone morrow function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Chronic heart failure | Left ventricular ejection fraction Echocardiography
Item
participants with a history of chronic heart failure must have cardiac echo indicating left ventricular ejection fraction (lvef) ≥ 45% within 21 days prior to first dose of study drug
boolean
C0264716 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment | Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Biological treatment | Therapy, Investigational | Phytotherapy
Item
received anti-cancer therapy including chemotherapy, immunotherapy, radiation, biologic, or any investigational therapy within a period of 21 days, herbal therapy within 7 days prior to the first dose of abbv-838, and have unresolved toxicities ≥
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
C0242388 (UMLS CUI [7])
Toxicity CTCAE Grades | Resolution Lacking
Item
grade 2
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Solid Neoplasm metastatic
Item
concurrent metastatic solid tumors
boolean
C0280100 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
M Protein Non-Measurable Serum | M Protein Non-Measurable In Urine | Serum Free Light Chain Measurable
Item
non-measurable m protein (serum or urine) and measurable sflc (< 100 mg/ml)
boolean
C0700271 (UMLS CUI [1,1])
C1518373 (UMLS CUI [1,2])
C0229671 (UMLS CUI [1,3])
C0700271 (UMLS CUI [2,1])
C1518373 (UMLS CUI [2,2])
C0042037 (UMLS CUI [2,3])
C2827352 (UMLS CUI [3,1])
C1513040 (UMLS CUI [3,2])
Major surgery
Item
major surgery within 21 days prior to the first dose of abbv-838
boolean
C0679637 (UMLS CUI [1])
Condition Clinical Significance Uncontrolled
Item
clinically significant uncontrolled condition(s) including but not limited to the following:
boolean
C0348080 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades | Pain | Hypercalcemia Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
grade ≥ 3 peripheral neuropathy or grade 2 peripheral neuropathy with pain uncontrolled hypercalcemia active uncontrolled infection symptomatic congestive heart failure unstable angina pectoris or cardiac arrhythmia psychiatric illness/social situation that would limit compliance with the study
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
C0020437 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0742758 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0004936 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C0439801 (UMLS CUI [9,2])
C0525058 (UMLS CUI [9,3])
Immunologic reaction Major Immunoglobulin G | Immunologic reaction Major Auristatin
Item
major immunologic reaction to any igg containing agent or auristatin based agent
boolean
C0301873 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0020852 (UMLS CUI [1,3])
C0301873 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C2742798 (UMLS CUI [2,3])
CYP3A4 Inhibitors Strong
Item
participants who are taking strong cyp3a4 inhibitors
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
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