ID

44447

Description

Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT01484314

Link

https://clinicaltrials.gov/show/NCT01484314

Keywords

  1. 9/22/21 9/22/21 -
Copyright Holder

Dana-Farber Cancer Institute

Uploaded on

September 22, 2021

DOI

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License

Creative Commons BY-NC 4.0

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Eligibility Thrombocytopenia NCT01484314

Eligibility Thrombocytopenia NCT01484314

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must have histologically confirmed multiple myeloma that is relapsed or refractory
Description

Relapsed multiple myeloma | Refractory multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2]
C0278620
patients may have had 1 or more prior chemotherapy regimens for multiple myeloma but none within the preceding 14 days
Description

Absence of recent chemotherapy regiement

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0332197
performance status (ecog) ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
not pregnant or breastfeeding
Description

Pregnancy absent | Breast Feeding absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants with a history of rapidly progressive disease [increase in tumor size (≥50%) as defined by standard myeloma markers ], pelvic irradiation, chemotherapy or radiotherapy within the preceding 14 days)
Description

History of rapidly progressive disease (increase in tumor size as defined by standard myeloma markers) | Pelvic irradiation | Recent chemotherapy | Recent radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1335499
UMLS CUI [1,3]
C0475440
UMLS CUI [1,4]
C0026764
UMLS CUI [1,5]
C0041365
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0030797
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0332185
participants may not be receiving any other study agents within 21 days prior to entry on the study.
Description

Recent use of other Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332185
the use of growth factors other than erythropoiesis stimulating agents or g-csf (neupogen or neulasta) during the study period.
Description

The use of growth factors other than erythropoiesis stimulating agents or g-csf (neupogen or neulasta) during the study period.

Data type

boolean

Alias
UMLS CUI [1,1]
C0079490
UMLS CUI [1,2]
C1959590
UMLS CUI [1,3]
C1705847
UMLS CUI [1,4]
C0733468
UMLS CUI [1,5]
C1705847
UMLS CUI [1,6]
C1171279
UMLS CUI [1,7]
C1705847
UMLS CUI [1,8]
C2347804
participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line).
Description

Active thromboembolic disease | History of recent thromboembolism except thrombosis of a central venous catether

Data type

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C2707252
UMLS CUI [2,1]
C0040038
UMLS CUI [2,2]
C0262926
UMLS CUI [2,3]
C0332185
UMLS CUI [2,4]
C1145640
UMLS CUI [2,5]
C0040053
UMLS CUI [2,6]
C1705847
participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, at-iii deficiency, etc.), platelet disorder or bleeding disorder.
Description

Genetic predisposition for thrombosis | Platelet disorder | Blood coagulation disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0314657
UMLS CUI [1,2]
C0040053
UMLS CUI [2]
C0005818
UMLS CUI [3]
C0005779
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.
Description

Uncontrolled comorbidity | Active infection | Symptomatic congestive heart failure | Unstable angina pectoris | Cardiac arrhythmia | Mental disorder | Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205177
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0205394
individuals with a history of other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancers are eligible if diagnosed and treated within the preceding 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Description

Other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence | Cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin are eligible if treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0332296
UMLS CUI [1,5]
C3538919
UMLS CUI [1,6]
C2825055
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C1548635
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C1548635
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C1548635

Similar models

Eligibility Thrombocytopenia NCT01484314

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Relapsed multiple myeloma | Refractory multiple myeloma
Item
participants must have histologically confirmed multiple myeloma that is relapsed or refractory
boolean
C1370446 (UMLS CUI [1])
C0278620 (UMLS CUI [2])
Absence of recent chemotherapy regiement
Item
patients may have had 1 or more prior chemotherapy regimens for multiple myeloma but none within the preceding 14 days
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
ECOG performance status
Item
performance status (ecog) ≤ 2
boolean
C1520224 (UMLS CUI [1])
Pregnancy absent | Breast Feeding absent
Item
not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
History of rapidly progressive disease (increase in tumor size as defined by standard myeloma markers) | Pelvic irradiation | Recent chemotherapy | Recent radiotherapy
Item
participants with a history of rapidly progressive disease [increase in tumor size (≥50%) as defined by standard myeloma markers ], pelvic irradiation, chemotherapy or radiotherapy within the preceding 14 days)
boolean
C0262926 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C0475440 (UMLS CUI [1,3])
C0026764 (UMLS CUI [1,4])
C0041365 (UMLS CUI [1,5])
C1522449 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Recent use of other Investigational New Drugs
Item
participants may not be receiving any other study agents within 21 days prior to entry on the study.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
The use of growth factors other than erythropoiesis stimulating agents or g-csf (neupogen or neulasta) during the study period.
Item
the use of growth factors other than erythropoiesis stimulating agents or g-csf (neupogen or neulasta) during the study period.
boolean
C0079490 (UMLS CUI [1,1])
C1959590 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0733468 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,5])
C1171279 (UMLS CUI [1,6])
C1705847 (UMLS CUI [1,7])
C2347804 (UMLS CUI [1,8])
Active thromboembolic disease | History of recent thromboembolism except thrombosis of a central venous catether
Item
participants with evidence of active thromboembolic disease or a history of thromboembolism within the preceding 6 months (excluding thrombosis of a central line).
boolean
C0040038 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C0040038 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1145640 (UMLS CUI [2,4])
C0040053 (UMLS CUI [2,5])
C1705847 (UMLS CUI [2,6])
Genetic predisposition for thrombosis | Platelet disorder | Blood coagulation disorder
Item
participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, at-iii deficiency, etc.), platelet disorder or bleeding disorder.
boolean
C0314657 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
C0005818 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
Uncontrolled comorbidity | Active infection | Symptomatic congestive heart failure | Unstable angina pectoris | Cardiac arrhythmia | Mental disorder | Other
Item
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])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0205394 (UMLS CUI [7])
Other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence | Cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin are eligible if treated
Item
individuals with a history of other malignancies are eligible only if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. individuals with the following cancers are eligible if diagnosed and treated within the preceding 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0332296 (UMLS CUI [1,4])
C3538919 (UMLS CUI [1,5])
C2825055 (UMLS CUI [1,6])
C0851140 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1548635 (UMLS CUI [2,3])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C1548635 (UMLS CUI [3,3])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C1548635 (UMLS CUI [4,3])

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