ID

21965

Description

Two Cycles of PAD Combination by AHCT in MM; ODM derived from: https://clinicaltrials.gov/show/NCT01370434

Link

https://clinicaltrials.gov/show/NCT01370434

Keywords

  1. 5/10/17 5/10/17 -
Uploaded on

May 10, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT01370434

Eligibility Multiple Myeloma NCT01370434

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with newly diagnosed symptomatic mm (see appendix i)
Description

Multiple Myeloma Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
patients should be eligible for ahct.
Description

Patient eligible Transplantation of autologous hematopoietic stem cell

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C1831743
patients should have measurable serum or urine paraprotein.
Description

Serum paraprotein measurement | Urine paraprotein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0585639
UMLS CUI [2]
C0585640
the performance status of the patients should be 70 or over by karnofsky performance scale
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
adequate hepatic and renal function: serum bilirubin < 1.5 x the upper limit of normal (uln), serum alanine aminotransferase (alt)/aspartate aminotransaminase (ast) values < 2.5 x uln, serum creatinine < 1.5 x uln
Description

Liver function | Renal function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201976
adequate cardiac function: ejection fraction > 40% by echocardiogram or radionuclide heart scan
Description

Cardiac function | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Radionuclide Imaging Heart

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C0034606
UMLS CUI [3,3]
C0018787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy for myeloma except 4 days of dexamethasone up to 40 mg per day or localized radiotherapy or plasmapheresis for the treatment of clinically significant hyperviscosity syndrome
Description

Chemotherapy Multiple Myeloma | Dexamethasone U/day | Therapeutic radiology procedure Localized | Plasmapheresis Hyperviscosity syndrome

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C0011777
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0392752
UMLS CUI [4,1]
C0032134
UMLS CUI [4,2]
C0221030
have a peripheral neuropathy of grade 2 or more within 14 days of enrollment.
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
significant infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450

Similar models

Eligibility Multiple Myeloma NCT01370434

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic
Item
patients with newly diagnosed symptomatic mm (see appendix i)
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient eligible Transplantation of autologous hematopoietic stem cell
Item
patients should be eligible for ahct.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C1831743 (UMLS CUI [1,3])
Serum paraprotein measurement | Urine paraprotein measurement
Item
patients should have measurable serum or urine paraprotein.
boolean
C0585639 (UMLS CUI [1])
C0585640 (UMLS CUI [2])
Karnofsky Performance Status
Item
the performance status of the patients should be 70 or over by karnofsky performance scale
boolean
C0206065 (UMLS CUI [1])
Liver function | Renal function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
adequate hepatic and renal function: serum bilirubin < 1.5 x the upper limit of normal (uln), serum alanine aminotransferase (alt)/aspartate aminotransaminase (ast) values < 2.5 x uln, serum creatinine < 1.5 x uln
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Radionuclide Imaging Heart
Item
adequate cardiac function: ejection fraction > 40% by echocardiogram or radionuclide heart scan
boolean
C0232164 (UMLS CUI [1])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0034606 (UMLS CUI [3,2])
C0018787 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Multiple Myeloma | Dexamethasone U/day | Therapeutic radiology procedure Localized | Plasmapheresis Hyperviscosity syndrome
Item
prior chemotherapy for myeloma except 4 days of dexamethasone up to 40 mg per day or localized radiotherapy or plasmapheresis for the treatment of clinically significant hyperviscosity syndrome
boolean
C0392920 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C0011777 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
C0032134 (UMLS CUI [4,1])
C0221030 (UMLS CUI [4,2])
Peripheral Neuropathy CTCAE Grades
Item
have a peripheral neuropathy of grade 2 or more within 14 days of enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Communicable Disease
Item
significant infection
boolean
C0009450 (UMLS CUI [1])

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