ID

36422

Beskrivning

Study of ACY-241 Alone and in Combination With Pomalidomide and Dexamethasone in Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02400242

Länk

https://clinicaltrials.gov/show/NCT02400242

Nyckelord

  1. 2019-05-14 2019-05-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 maj 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT02400242

Eligibility Multiple Myeloma NCT02400242

Criteria
Beskrivning

Criteria

must have a documented diagnosis of mm and have relapsed or relapsed-and-refractory disease. all patients must have relapsed after having achieved at least stable disease (sd) for at least 1 cycle of treatment to at least 1 prior regimen and then developed progressive disease (pd). relapsed-and-refractory patients also have documented evidence of pd during or within 60 days of completing last treatment
Beskrivning

Multiple Myeloma | Multiple myeloma recurrent | Multiple myeloma recurrent Refractory | Status post Stable Disease | Therapeutic procedure Quantity | Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C1370446
UMLS CUI [3,1]
C1370446
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0677946
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C1265611
UMLS CUI [6]
C1335499
must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of proteasome inhibitor unless not a candidate.
Beskrivning

Prior Therapy Quantity | lenalidomide | Proteasome inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1144149
UMLS CUI [3]
C1443643
may have undergone prior treatment with pomalidomide if patient previously achieved a response of minimal response (mr) or better to pomalidomide.
Beskrivning

Prior Therapy | pomalidomide | Disease Response Pomalidomide | Minimal response Pomalidomide | Partial response Pomalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C2347624
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C2347624
UMLS CUI [4,1]
C0184783
UMLS CUI [4,2]
C2347624
UMLS CUI [5,1]
C1521726
UMLS CUI [5,2]
C2347624
must have measurable disease (serum m-protein or urine m-protein).
Beskrivning

Measurable Disease | Serum M Protein | Urine M Protein

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0700271
UMLS CUI [3,1]
C0042036
UMLS CUI [3,2]
C0700271
must have eastern cooperative oncology group (ecog) performance score of 0, 1, or 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
must be able to take low-dose aspirin, low molecular weight heparin, or other equivalent antithrombotic or anticoagulant daily as prophylactic anticoagulation.
Beskrivning

Aspirin Low Dose | Heparin, Low-Molecular-Weight | Antithrombotic Agents Equivalent Daily | Anticoagulants Equivalent Daily | Prophylactic anticoagulation

Datatyp

boolean

Alias
UMLS CUI [1]
C2608320
UMLS CUI [2]
C0019139
UMLS CUI [3,1]
C1704311
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0332173
UMLS CUI [4,1]
C0003280
UMLS CUI [4,2]
C0205163
UMLS CUI [4,3]
C0332173
UMLS CUI [5]
C4304154
key exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
prior therapy with pomalidomide with best response of pd or sd.
Beskrivning

Prior Therapy | pomalidomide | Response Progressive Disease | Response Stable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C2347624
UMLS CUI [3,1]
C1704632
UMLS CUI [3,2]
C1335499
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C0677946
prior therapy with histone deacetylase (hdac) inhibitor.
Beskrivning

Prior Therapy | Histone deacetylase inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1512474
any of the following laboratory abnormalities: absolute neutrophil count(anc) < 1,000/µl, platelet count < 75,000/µl or < 50,000/µl for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells, hemoglobin < 8 g/dl, creatinine clearance < 45 ml/min according to cockcroft-gault formula. if creatinine clearance calculated from the 24 hour urine sample is ≥ 45 ml/min, patient will qualify for the trial, aspartate transaminase (ast) or alanine transaminase (alt) > 3.0 × upper limited normal (uln), serum total bilirubin > 2.0 mg/dl or > 3.0 × uln for patients with hereditary benign hyperbilirubinaemia.
Beskrivning

Laboratory test result abnormal | Absolute neutrophil count | Platelet Count measurement | Nucleated cells Bone marrow Percentage Plasma Cells | Hemoglobin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Estimation of creatinine clearance by Cockcroft-Gault formula 24 hour urine sample | Aspartate aminotransferase increased | Alanine aminotransferase increased | SERUM TOTAL BILIRUBIN ELEVATED | Hereditary Benign Hyperbilirubinemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C2738468
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0032112
UMLS CUI [5]
C0518015
UMLS CUI [6]
C2711451
UMLS CUI [7,1]
C2711451
UMLS CUI [7,2]
C0456209
UMLS CUI [8]
C0151904
UMLS CUI [9]
C0151905
UMLS CUI [10]
C0595866
UMLS CUI [11,1]
C0020435
UMLS CUI [11,2]
C0205183
hematologic growth factors are not allowed at screening or during the first cycle of phase 1a or 1b.
Beskrivning

Growth Factors Hematologic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C0205488
nonsecretory myeloma or free light chain detected in serum only (ogliosecretory).
Beskrivning

Non-secretory myeloma | Serum Free Light Chain | Myeloma M Protein Very low

Datatyp

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2]
C2827352
UMLS CUI [3,1]
C0026764
UMLS CUI [3,2]
C0700271
UMLS CUI [3,3]
C0442811
hypersensitivity to thalidomide, lenalidomide, pomalidomide, or dexamethasone
Beskrivning

Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide | Hypersensitivity Pomalidomide | Dexamethasone allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1144149
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C2347624
UMLS CUI [4]
C0571611
patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study
Beskrivning

Allogeneic bone marrow transplantation | Allogeneic peripheral blood stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0149615
UMLS CUI [2]
C1960580

Similar models

Eligibility Multiple Myeloma NCT02400242

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Multiple Myeloma | Multiple myeloma recurrent | Multiple myeloma recurrent Refractory | Status post Stable Disease | Therapeutic procedure Quantity | Progressive Disease
Item
must have a documented diagnosis of mm and have relapsed or relapsed-and-refractory disease. all patients must have relapsed after having achieved at least stable disease (sd) for at least 1 cycle of treatment to at least 1 prior regimen and then developed progressive disease (pd). relapsed-and-refractory patients also have documented evidence of pd during or within 60 days of completing last treatment
boolean
C0026764 (UMLS CUI [1])
C1370446 (UMLS CUI [2])
C1370446 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0677946 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C1335499 (UMLS CUI [6])
Prior Therapy Quantity | lenalidomide | Proteasome inhibitor
Item
must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of proteasome inhibitor unless not a candidate.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1144149 (UMLS CUI [2])
C1443643 (UMLS CUI [3])
Prior Therapy | pomalidomide | Disease Response Pomalidomide | Minimal response Pomalidomide | Partial response Pomalidomide
Item
may have undergone prior treatment with pomalidomide if patient previously achieved a response of minimal response (mr) or better to pomalidomide.
boolean
C1514463 (UMLS CUI [1])
C2347624 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C2347624 (UMLS CUI [3,2])
C0184783 (UMLS CUI [4,1])
C2347624 (UMLS CUI [4,2])
C1521726 (UMLS CUI [5,1])
C2347624 (UMLS CUI [5,2])
Measurable Disease | Serum M Protein | Urine M Protein
Item
must have measurable disease (serum m-protein or urine m-protein).
boolean
C1513041 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0042036 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
ECOG performance status
Item
must have eastern cooperative oncology group (ecog) performance score of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Aspirin Low Dose | Heparin, Low-Molecular-Weight | Antithrombotic Agents Equivalent Daily | Anticoagulants Equivalent Daily | Prophylactic anticoagulation
Item
must be able to take low-dose aspirin, low molecular weight heparin, or other equivalent antithrombotic or anticoagulant daily as prophylactic anticoagulation.
boolean
C2608320 (UMLS CUI [1])
C0019139 (UMLS CUI [2])
C1704311 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
C0003280 (UMLS CUI [4,1])
C0205163 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
C4304154 (UMLS CUI [5])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Prior Therapy | pomalidomide | Response Progressive Disease | Response Stable Disease
Item
prior therapy with pomalidomide with best response of pd or sd.
boolean
C1514463 (UMLS CUI [1])
C2347624 (UMLS CUI [2])
C1704632 (UMLS CUI [3,1])
C1335499 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4,1])
C0677946 (UMLS CUI [4,2])
Prior Therapy | Histone deacetylase inhibitor
Item
prior therapy with histone deacetylase (hdac) inhibitor.
boolean
C1514463 (UMLS CUI [1])
C1512474 (UMLS CUI [2])
Laboratory test result abnormal | Absolute neutrophil count | Platelet Count measurement | Nucleated cells Bone marrow Percentage Plasma Cells | Hemoglobin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Estimation of creatinine clearance by Cockcroft-Gault formula 24 hour urine sample | Aspartate aminotransferase increased | Alanine aminotransferase increased | SERUM TOTAL BILIRUBIN ELEVATED | Hereditary Benign Hyperbilirubinemia
Item
any of the following laboratory abnormalities: absolute neutrophil count(anc) < 1,000/µl, platelet count < 75,000/µl or < 50,000/µl for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells, hemoglobin < 8 g/dl, creatinine clearance < 45 ml/min according to cockcroft-gault formula. if creatinine clearance calculated from the 24 hour urine sample is ≥ 45 ml/min, patient will qualify for the trial, aspartate transaminase (ast) or alanine transaminase (alt) > 3.0 × upper limited normal (uln), serum total bilirubin > 2.0 mg/dl or > 3.0 × uln for patients with hereditary benign hyperbilirubinaemia.
boolean
C0438215 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C2738468 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0032112 (UMLS CUI [4,3])
C0518015 (UMLS CUI [5])
C2711451 (UMLS CUI [6])
C2711451 (UMLS CUI [7,1])
C0456209 (UMLS CUI [7,2])
C0151904 (UMLS CUI [8])
C0151905 (UMLS CUI [9])
C0595866 (UMLS CUI [10])
C0020435 (UMLS CUI [11,1])
C0205183 (UMLS CUI [11,2])
Growth Factors Hematologic
Item
hematologic growth factors are not allowed at screening or during the first cycle of phase 1a or 1b.
boolean
C0018284 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
Non-secretory myeloma | Serum Free Light Chain | Myeloma M Protein Very low
Item
nonsecretory myeloma or free light chain detected in serum only (ogliosecretory).
boolean
C0456845 (UMLS CUI [1])
C2827352 (UMLS CUI [2])
C0026764 (UMLS CUI [3,1])
C0700271 (UMLS CUI [3,2])
C0442811 (UMLS CUI [3,3])
Hypersensitivity Thalidomide | Hypersensitivity Lenalidomide | Hypersensitivity Pomalidomide | Dexamethasone allergy
Item
hypersensitivity to thalidomide, lenalidomide, pomalidomide, or dexamethasone
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1144149 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C2347624 (UMLS CUI [3,2])
C0571611 (UMLS CUI [4])
Allogeneic bone marrow transplantation | Allogeneic peripheral blood stem cell transplant
Item
patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study
boolean
C0149615 (UMLS CUI [1])
C1960580 (UMLS CUI [2])

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