ID

15548

Beschrijving

Phase 2b Open-Label Single-Arm Study With KPT-330 & Dexamethasone in Patients w/ Quad-refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02336815

Link

https://clinicaltrials.gov/show/NCT02336815

Trefwoorden

Versies (1)
  1. 02-06-16 02-06-16 -
Geüploaded op

2 juni 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02336815

Engels

Eligibility Multiple Myeloma NCT02336815

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
symptomatic mm, based on imwg guidelines. patients must have measurable disease as defined by at least one of the following:
Beschrijving

Multiple Myeloma Symptomatic | Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1513041
1. serum m-protein ≥ 0.5 g/dl by serum electrophoresis (spep) or for iga myeloma, by quantitative iga; or
Beschrijving

M Protein | Serum protein electrophoresis | IgA myeloma | Immunoglobulin A measurement Quantitative

Datatype

boolean

Alias
UMLS CUI [1]
C0700271
UMLS CUI [2]
C0201720
UMLS CUI [3]
C0563305
UMLS CUI [4,1]
C0202083
UMLS CUI [4,2]
C0392762
2. urinary m-protein excretion at least 200 mg/24 hours; or
Beschrijving

Excretion measurement M Protein In Urine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201808
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0042037
3. serum free light chain (flc) whereby the involved light chain measures ≥ 10 mg/dl and with an abnormal light chain ratio.
Beschrijving

Serum Free Immunoglobulin Light Chain | Serum Immunoglobulin Free Light Chain Ratio Abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C2827352
UMLS CUI [2]
C2826181
patients must have received ≥ 3 prior anti-mm regimens including the following: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib and a glucocorticoid. there is no upper limit on the number of prior therapies provided that all other inclusion/exclusion criteria are met.
Beschrijving

Therapeutic regimen Multiple Myeloma | Alkylating Agents | lenalidomide | pomalidomide | bortezomib | carfilzomib | Glucocorticoids

Datatype

boolean

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0026764
UMLS CUI [2]
C0002073
UMLS CUI [3]
C1144149
UMLS CUI [4]
C2347624
UMLS CUI [5]
C1176309
UMLS CUI [6]
C2001856
UMLS CUI [7]
C0017710
quad-refractory mm: mm refractory to lenalidomide, pomalidomide, bortezomib, and carfilzomib. refractory is defined as ≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy.
Beschrijving

Multiple Myeloma Unresponsive to Treatment lenalidomide pomalidomide bortezomib carfilzomib | Disease Progression

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C1144149
UMLS CUI [1,4]
C2347624
UMLS CUI [1,5]
C1176309
UMLS CUI [1,6]
C2001856
UMLS CUI [2]
C0242656
penta-refractory mm: 25% of patients must have mm refractory to lenalidomide, pomalidomide, bortezomib, carfilzomib, and at least one anti-cd38 mab (e.g., sar 650984 or daratumumab)
Beschrijving

Multiple Myeloma Unresponsive to Treatment lenalidomide pomalidomide bortezomib carfilzomib daratumumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C1144149
UMLS CUI [1,4]
C2347624
UMLS CUI [1,5]
C1176309
UMLS CUI [1,6]
C2001856
UMLS CUI [1,7]
C2346801
multiple myeloma refractory to the patient's most recent anti-mm regimen.
Beschrijving

Multiple Myeloma Unresponsive to Treatment Most Recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C1513491
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoldering mm.
Beschrijving

Smoldering myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C1531608
plasma cell leukemia.
Beschrijving

Leukemia, Plasma Cell

Datatype

boolean

Alias
UMLS CUI [1]
C0023484
mm that does not express m-protein or flc (i.e., non-secretory mm is excluded; plasmacytomas without m-protein or flc are excluded).
Beschrijving

Multiple Myeloma | Gene Expression | M Protein | Serum Free Immunoglobulin Light Chain | Non-secretory myeloma | Plasmacytoma

Datatype

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2]
C0017262
UMLS CUI [3]
C0700271
UMLS CUI [4]
C2827352
UMLS CUI [5]
C0456845
UMLS CUI [6]
C0032131
documented systemic amyloid light chain amyloidosis.
Beschrijving

Primary amyloidosis of light chain type | Systemic amyloidosis | Amyloid

Datatype

boolean

Alias
UMLS CUI [1]
C0342606
UMLS CUI [2]
C0268380
UMLS CUI [3]
C0002716
active cns mm.
Beschrijving

Central Nervous System Involvement with Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0026764
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Similar models

Eligibility Multiple Myeloma NCT02336815

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic | Measurable Disease
Item
symptomatic mm, based on imwg guidelines. patients must have measurable disease as defined by at least one of the following:
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2])
M Protein | Serum protein electrophoresis | IgA myeloma | Immunoglobulin A measurement Quantitative
Item
1. serum m-protein ≥ 0.5 g/dl by serum electrophoresis (spep) or for iga myeloma, by quantitative iga; or
boolean
C0700271 (UMLS CUI [1])
C0201720 (UMLS CUI [2])
C0563305 (UMLS CUI [3])
C0202083 (UMLS CUI [4,1])
C0392762 (UMLS CUI [4,2])
Excretion measurement M Protein In Urine
Item
2. urinary m-protein excretion at least 200 mg/24 hours; or
boolean
C0201808 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0042037 (UMLS CUI [1,3])
Serum Free Immunoglobulin Light Chain | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
3. serum free light chain (flc) whereby the involved light chain measures ≥ 10 mg/dl and with an abnormal light chain ratio.
boolean
C2827352 (UMLS CUI [1])
C2826181 (UMLS CUI [2])
Therapeutic regimen Multiple Myeloma | Alkylating Agents | lenalidomide | pomalidomide | bortezomib | carfilzomib | Glucocorticoids
Item
patients must have received ≥ 3 prior anti-mm regimens including the following: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib and a glucocorticoid. there is no upper limit on the number of prior therapies provided that all other inclusion/exclusion criteria are met.
boolean
C1276413 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0002073 (UMLS CUI [2])
C1144149 (UMLS CUI [3])
C2347624 (UMLS CUI [4])
C1176309 (UMLS CUI [5])
C2001856 (UMLS CUI [6])
C0017710 (UMLS CUI [7])
Multiple Myeloma Unresponsive to Treatment lenalidomide pomalidomide bortezomib carfilzomib | Disease Progression
Item
quad-refractory mm: mm refractory to lenalidomide, pomalidomide, bortezomib, and carfilzomib. refractory is defined as ≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy.
boolean
C0026764 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,3])
C2347624 (UMLS CUI [1,4])
C1176309 (UMLS CUI [1,5])
C2001856 (UMLS CUI [1,6])
C0242656 (UMLS CUI [2])
Multiple Myeloma Unresponsive to Treatment lenalidomide pomalidomide bortezomib carfilzomib daratumumab
Item
penta-refractory mm: 25% of patients must have mm refractory to lenalidomide, pomalidomide, bortezomib, carfilzomib, and at least one anti-cd38 mab (e.g., sar 650984 or daratumumab)
boolean
C0026764 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,3])
C2347624 (UMLS CUI [1,4])
C1176309 (UMLS CUI [1,5])
C2001856 (UMLS CUI [1,6])
C2346801 (UMLS CUI [1,7])
Multiple Myeloma Unresponsive to Treatment Most Recent
Item
multiple myeloma refractory to the patient's most recent anti-mm regimen.
boolean
C0026764 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Smoldering myeloma
Item
smoldering mm.
boolean
C1531608 (UMLS CUI [1])
Leukemia, Plasma Cell
Item
plasma cell leukemia.
boolean
C0023484 (UMLS CUI [1])
Multiple Myeloma | Gene Expression | M Protein | Serum Free Immunoglobulin Light Chain | Non-secretory myeloma | Plasmacytoma
Item
mm that does not express m-protein or flc (i.e., non-secretory mm is excluded; plasmacytomas without m-protein or flc are excluded).
boolean
C0026764 (UMLS CUI [1])
C0017262 (UMLS CUI [2])
C0700271 (UMLS CUI [3])
C2827352 (UMLS CUI [4])
C0456845 (UMLS CUI [5])
C0032131 (UMLS CUI [6])
Primary amyloidosis of light chain type | Systemic amyloidosis | Amyloid
Item
documented systemic amyloid light chain amyloidosis.
boolean
C0342606 (UMLS CUI [1])
C0268380 (UMLS CUI [2])
C0002716 (UMLS CUI [3])
Central Nervous System Involvement with Multiple Myeloma
Item
active cns mm.
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
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