ID

15548

Description

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

Keywords

  1. 6/2/16 6/2/16 -
Uploaded on

June 2, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT02336815

Eligibility Multiple Myeloma NCT02336815

Inclusion Criteria
Description

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:
Description

Multiple Myeloma Symptomatic | Measurable Disease

Data type

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
Description

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

Data type

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
Description

Excretion measurement M Protein In Urine

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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)
Description

Multiple Myeloma Unresponsive to Treatment lenalidomide pomalidomide bortezomib carfilzomib daratumumab

Data type

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.
Description

Multiple Myeloma Unresponsive to Treatment Most Recent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoldering mm.
Description

Smoldering myeloma

Data type

boolean

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

Leukemia, Plasma Cell

Data type

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).
Description

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

Data type

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.
Description

Primary amyloidosis of light chain type | Systemic amyloidosis | Amyloid

Data type

boolean

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

Central Nervous System Involvement with Multiple Myeloma

Data type

boolean

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

Similar models

Eligibility Multiple Myeloma NCT02336815

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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