ID

44127

Description

Trisenox, Ascorbic Acid and Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00590603

Link

https://clinicaltrials.gov/show/NCT00590603

Keywords

Versions (2)
  1. 6/26/18 6/26/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00590603

English

Eligibility Multiple Myeloma NCT00590603

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of relapsed/refractory multiple myeloma.
Description

Recurrent multiple myeloma | Refractory multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2]
C0278620
patients must have measurable disease, defined as localized plasmacytoma, detectable m-spike by serum protein electrophoresis (spep) and/or urine protein electrophoresis (upep), or free light chain assay, bone lytic lesions and/or bone marrow infiltration with atypical plasma-cells.
Description

Measurable Disease | Plasmacytoma Localized | m-spike Serum protein electrophoresis | m-spike Urine protein electrophoresis | Free Immunoglobulin Light Chain Assay | Osteolytic lesion | Bone marrow infiltration Plasma Cells Atypical

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0032131
UMLS CUI [2,2]
C0392752
UMLS CUI [3,1]
C0241988
UMLS CUI [3,2]
C0201720
UMLS CUI [4,1]
C0241988
UMLS CUI [4,2]
C0201721
UMLS CUI [5,1]
C0806492
UMLS CUI [5,2]
C1510438
UMLS CUI [6]
C0302313
UMLS CUI [7,1]
C3854434
UMLS CUI [7,2]
C0032112
UMLS CUI [7,3]
C0205182
patients must be at least four weeks since their prior therapy. patients will not be excluded because of any prior regimen they have received as long as they meet other requirements.
Description

Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514463
adequate organ function, patients with elevated creatinine due to myeloma are not excluded
Description

Organ function | Serum creatinine raised Due to Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0700225
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0026764
eastern cooperative oncology group (ecog) performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
serum potassium greater than 4.0 milliequivalent (meq)/dl and serum magnesium greater than 1.8 mg/dl. if these electrolytes are below the specified limits on the baseline laboratory tests, supplemental electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.
Description

Serum potassium measurement | Serum magnesium measurement | Electrolytes Supplemental As Needed | Arsenic trioxide

Data type

boolean

Alias
UMLS CUI [1]
C0302353
UMLS CUI [2]
C0202125
UMLS CUI [3,1]
C0013832
UMLS CUI [3,2]
C2348609
UMLS CUI [3,3]
C1720688
UMLS CUI [4]
C0052416
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients may not be receiving any other investigational agents.
Description

Investigational New Drugs Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, trisenox, ascorbic acid, or other agents used in the study.
Description

Allergic Reaction Compound Bortezomib Similar | Allergic Reaction Compound Trisenox Similar | Allergic Reaction Compound Ascorbic Acid Similar | Allergic Reaction Compound Investigational New Drugs Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C1176309
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C1096917
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C0003968
UMLS CUI [3,4]
C2348205
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C0013230
UMLS CUI [4,4]
C2348205
corrected qt interval (qtc) interval greater than 460 msec in the presence of serum potassium greater than or equal to 4.0 meq/l and magnesium greater than or equal to 1.8 mg/dl, or underlying conduction disease that prevents measurement of the qtc interval.
Description

Prolonged QTc interval | Serum potassium measurement | Serum magnesium measurement | Conduction disorder Preventing QTc interval Measurement

Data type

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2]
C0302353
UMLS CUI [3]
C0202125
UMLS CUI [4,1]
C0264886
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0489625
UMLS CUI [4,4]
C0242485
history of ventricular tachycardia or any cardiac arrhythmia requiring the placement of an automated intraventricular cardiac defibrillator or therapy with class i or class ii antiarrhythmic drug.
Description

Tachycardia, Ventricular | Cardiac Arrhythmia Requirement Automatic Implantable Cardioverter-Defibrillators | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents Class

Data type

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0972395
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0003195
UMLS CUI [3,4]
C0456387
ejection fraction (ef) by multigated acquisition (muga) scan less than 35%.
Description

Cardiac ejection fraction MUGA scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
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Similar models

Eligibility Multiple Myeloma NCT00590603

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent multiple myeloma | Refractory multiple myeloma
Item
diagnosis of relapsed/refractory multiple myeloma.
boolean
C1370446 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
Measurable Disease | Plasmacytoma Localized | m-spike Serum protein electrophoresis | m-spike Urine protein electrophoresis | Free Immunoglobulin Light Chain Assay | Osteolytic lesion | Bone marrow infiltration Plasma Cells Atypical
Item
patients must have measurable disease, defined as localized plasmacytoma, detectable m-spike by serum protein electrophoresis (spep) and/or urine protein electrophoresis (upep), or free light chain assay, bone lytic lesions and/or bone marrow infiltration with atypical plasma-cells.
boolean
C1513041 (UMLS CUI [1])
C0032131 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C0241988 (UMLS CUI [3,1])
C0201720 (UMLS CUI [3,2])
C0241988 (UMLS CUI [4,1])
C0201721 (UMLS CUI [4,2])
C0806492 (UMLS CUI [5,1])
C1510438 (UMLS CUI [5,2])
C0302313 (UMLS CUI [6])
C3854434 (UMLS CUI [7,1])
C0032112 (UMLS CUI [7,2])
C0205182 (UMLS CUI [7,3])
Prior Therapy
Item
patients must be at least four weeks since their prior therapy. patients will not be excluded because of any prior regimen they have received as long as they meet other requirements.
boolean
C1514463 (UMLS CUI [1])
Organ function | Serum creatinine raised Due to Myeloma
Item
adequate organ function, patients with elevated creatinine due to myeloma are not excluded
boolean
C0678852 (UMLS CUI [1])
C0700225 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Serum potassium measurement | Serum magnesium measurement | Electrolytes Supplemental As Needed | Arsenic trioxide
Item
serum potassium greater than 4.0 milliequivalent (meq)/dl and serum magnesium greater than 1.8 mg/dl. if these electrolytes are below the specified limits on the baseline laboratory tests, supplemental electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.
boolean
C0302353 (UMLS CUI [1])
C0202125 (UMLS CUI [2])
C0013832 (UMLS CUI [3,1])
C2348609 (UMLS CUI [3,2])
C1720688 (UMLS CUI [3,3])
C0052416 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs Other
Item
patients may not be receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Allergic Reaction Compound Bortezomib Similar | Allergic Reaction Compound Trisenox Similar | Allergic Reaction Compound Ascorbic Acid Similar | Allergic Reaction Compound Investigational New Drugs Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, trisenox, ascorbic acid, or other agents used in the study.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C1176309 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C1096917 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C0003968 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
Prolonged QTc interval | Serum potassium measurement | Serum magnesium measurement | Conduction disorder Preventing QTc interval Measurement
Item
corrected qt interval (qtc) interval greater than 460 msec in the presence of serum potassium greater than or equal to 4.0 meq/l and magnesium greater than or equal to 1.8 mg/dl, or underlying conduction disease that prevents measurement of the qtc interval.
boolean
C1560305 (UMLS CUI [1])
C0302353 (UMLS CUI [2])
C0202125 (UMLS CUI [3])
C0264886 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0489625 (UMLS CUI [4,3])
C0242485 (UMLS CUI [4,4])
Tachycardia, Ventricular | Cardiac Arrhythmia Requirement Automatic Implantable Cardioverter-Defibrillators | Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents Class
Item
history of ventricular tachycardia or any cardiac arrhythmia requiring the placement of an automated intraventricular cardiac defibrillator or therapy with class i or class ii antiarrhythmic drug.
boolean
C0042514 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0972395 (UMLS CUI [2,3])
C0003811 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003195 (UMLS CUI [3,3])
C0456387 (UMLS CUI [3,4])
Cardiac ejection fraction MUGA scan
Item
ejection fraction (ef) by multigated acquisition (muga) scan less than 35%.
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
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