ID

15976

Beskrivning

Bortezomib, Dexamethasone, and Cyclophosphamide in Treating Older Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02082405

Länk

https://clinicaltrials.gov/show/NCT02082405

Nyckelord

Versioner (1)
  1. 2016-06-22 2016-06-22 -
Uppladdad den

22 juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Stage I Multiple Myeloma NCT02082405

Engelsk

Eligibility Stage I Multiple Myeloma NCT02082405

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a confirmed diagnosis of symptomatic myeloma in accordance with international myeloma working group (imwg) criteria
Beskrivning

Multiple Myeloma Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
Beskrivning

BONE MARROW PLASMACYTOSIS | Plasma Cells | Plasmacytoma | Biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0238803
UMLS CUI [2]
C0032112
UMLS CUI [3]
C0032131
UMLS CUI [4]
C0005558
symptomatic disease, i.e., end-organ damage due to multiple myeloma (mm) including at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction
Beskrivning

Disease Symptomatic | end organ damage Due to Multiple Myeloma | Anemia | Hypercalcemia | Bone Diseases | Lytic lesion | Pathological fracture | Renal dysfunction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0743496
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0026764
UMLS CUI [3]
C0002871
UMLS CUI [4]
C0020437
UMLS CUI [5]
C0005940
UMLS CUI [6]
C0221204
UMLS CUI [7]
C0016663
UMLS CUI [8]
C3279454
absolute neutrophil count (anc) >= 1000 cells/mm^3 (without use of growth factors)
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets >= 50,000 cells/mm^3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
direct bilirubin =< 1.5 x upper limit of normal (uln); elevated bilirubin is permissible if patient has a known history of elevated bilirubin due to gilbert's or if elevated bilirubin is due to hemolysis
Beskrivning

Bilirubin, direct measurement | Increased bilirubin level Due to Gilbert Disease | Increased bilirubin level Due to Hemolysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0201916
UMLS CUI [2,1]
C0311468
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0017551
UMLS CUI [3,1]
C0311468
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0019054
alanine aminotransferase (alt) (serum glutamate pyruvate transaminase [sgpt]) =< 1.5 x uln
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
subjects must have the ability to understand and the willingness to sign a written informed consent document
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with > 1 cycle of any plasma cell myeloma (pcm) induction regimen (maximum 6 weeks of prior treatment)
Beskrivning

Prior Therapy | Multiple Myeloma Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0026764
UMLS CUI [2,2]
C0600558
prior radiation therapy is allowed
Beskrivning

prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
prior treatment for other cancers is allowed as long as patient meets criteria for adequate hematopoietic and organ function and is not actively on chemotherapy for another cancer
Beskrivning

Prior Therapy Malignant Neoplasms Other | physiological aspects Hematopoietic | organ function | Chemotherapy Malignant Neoplasm Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0031843
UMLS CUI [2,2]
C0229601
UMLS CUI [3]
C0678852
UMLS CUI [4,1]
C3665472
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C0205394
grade >= 2 peripheral neuropathy
Beskrivning

Peripheral Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0031117
second malignancy currently undergoing chemotherapy or radiotherapy; hormonal therapy for breast or prostate cancer is allowed
Beskrivning

Neoplasms, Second Primary | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy Breast Carcinoma | Hormone Therapy Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C0678222
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C0600139
patients may not be receiving any other investigational agents
Beskrivning

Investigational New Drugs Other

Datatyp

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, cyclophosphamide, dexamethasone or other agents used in this study
Beskrivning

Allergic Reaction bortezomib | Allergic Reaction Cyclophosphamide | Allergic Reaction Dexamethasone | Allergic Reaction Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0010583
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0011777
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0013230
patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Beskrivning

Comorbidity Compliance behavior Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders | social situation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0748872
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Similar models

Eligibility Stage I Multiple Myeloma NCT02082405

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic
Item
patients must have a confirmed diagnosis of symptomatic myeloma in accordance with international myeloma working group (imwg) criteria
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
BONE MARROW PLASMACYTOSIS | Plasma Cells | Plasmacytoma | Biopsy
Item
bone marrow plasmacytosis with > 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
boolean
C0238803 (UMLS CUI [1])
C0032112 (UMLS CUI [2])
C0032131 (UMLS CUI [3])
C0005558 (UMLS CUI [4])
Disease Symptomatic | end organ damage Due to Multiple Myeloma | Anemia | Hypercalcemia | Bone Diseases | Lytic lesion | Pathological fracture | Renal dysfunction
Item
symptomatic disease, i.e., end-organ damage due to multiple myeloma (mm) including at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction
boolean
C0012634 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0743496 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C0002871 (UMLS CUI [3])
C0020437 (UMLS CUI [4])
C0005940 (UMLS CUI [5])
C0221204 (UMLS CUI [6])
C0016663 (UMLS CUI [7])
C3279454 (UMLS CUI [8])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >= 1000 cells/mm^3 (without use of growth factors)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >= 50,000 cells/mm^3
boolean
C0032181 (UMLS CUI [1])
Bilirubin, direct measurement | Increased bilirubin level Due to Gilbert Disease | Increased bilirubin level Due to Hemolysis
Item
direct bilirubin =< 1.5 x upper limit of normal (uln); elevated bilirubin is permissible if patient has a known history of elevated bilirubin due to gilbert's or if elevated bilirubin is due to hemolysis
boolean
C0201916 (UMLS CUI [1])
C0311468 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
C0311468 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0019054 (UMLS CUI [3,3])
Alanine aminotransferase measurement
Item
alanine aminotransferase (alt) (serum glutamate pyruvate transaminase [sgpt]) =< 1.5 x uln
boolean
C0201836 (UMLS CUI [1])
Informed consent
Item
subjects must have the ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | Multiple Myeloma Neoadjuvant Therapy
Item
prior treatment with > 1 cycle of any plasma cell myeloma (pcm) induction regimen (maximum 6 weeks of prior treatment)
boolean
C1514463 (UMLS CUI [1])
C0026764 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
prior radiation therapy
Item
prior radiation therapy is allowed
boolean
C0279134 (UMLS CUI [1])
Prior Therapy Malignant Neoplasms Other | physiological aspects Hematopoietic | organ function | Chemotherapy Malignant Neoplasm Other
Item
prior treatment for other cancers is allowed as long as patient meets criteria for adequate hematopoietic and organ function and is not actively on chemotherapy for another cancer
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0031843 (UMLS CUI [2,1])
C0229601 (UMLS CUI [2,2])
C0678852 (UMLS CUI [3])
C3665472 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0205394 (UMLS CUI [4,3])
Peripheral Neuropathy
Item
grade >= 2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
Neoplasms, Second Primary | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy Breast Carcinoma | Hormone Therapy Prostate carcinoma
Item
second malignancy currently undergoing chemotherapy or radiotherapy; hormonal therapy for breast or prostate cancer is allowed
boolean
C0085183 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
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 bortezomib | Allergic Reaction Cyclophosphamide | Allergic Reaction Dexamethasone | Allergic Reaction Investigational New Drugs
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, cyclophosphamide, dexamethasone or other agents used in this study
boolean
C1527304 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0010583 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0011777 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
Comorbidity Compliance behavior Limited | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders | social situation
Item
patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0748872 (UMLS CUI [7])
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