ID

24644

Description

Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00570180

Link

https://clinicaltrials.gov/show/NCT00570180

Keywords

  1. 8/10/17 8/10/17 -
Uploaded on

August 10, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00570180

Eligibility Multiple Myeloma NCT00570180

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients previously diagnosed with mm based on criteria from the international myeloma working group (imwg)
Description

Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
patients who have 'measurable' disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
age 18 years at the time of signing informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
a patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed on the current regimen and the other eligibility criteria are met.
Description

Therapeutic procedure Additional Multiple Myeloma | Remission Induction Therapy | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0026764
UMLS CUI [2]
C1514832
UMLS CUI [3]
C2348568
patient is t(4;14) positive on screening assay.
Description

t(4;14) Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C2986942
UMLS CUI [1,2]
C1514241
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concomitant therapy medications that include corticosteroids (> 10 mg per day of prednisone or equivalent) or other therapy that is or may be active against myeloma prior to day 1 (with the exception of radiation therapy or induction therapy as described under the above inclusion criteria section
Description

Pharmacotherapy | Adrenal Cortex Hormones | Prednisone U/day | Therapeutic procedure Myeloma | Therapeutic radiology procedure Excluded | Remission Induction Therapy Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0026764
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C2828389
UMLS CUI [6,1]
C1514832
UMLS CUI [6,2]
C2828389
peripheral neuropathy of grade 2 or greater.
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
patients with evidence of mucosal or internal bleeding and/or refractoriness to platelet transfusions (i.e., unable to maintain a platelet count 50 x 109 /l).
Description

Mucosal bleeding | Internal hemorrhage | Platelet Transfusion refractory | Platelet count Maintenance Unable

Data type

boolean

Alias
UMLS CUI [1]
C2748540
UMLS CUI [2]
C1390214
UMLS CUI [3,1]
C0086818
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C1287267
UMLS CUI [4,2]
C0024501
UMLS CUI [4,3]
C1299582
patients with an absolute neutrophil count (anc) < 1.0 x 109/l. treatment to raise the anc, such as granulocyte colony-stimulating factor (g-csf) or granulocyte-macrophage colony-stimulating factor (gm-csf) is not allowed within 14 days of study entry.
Description

Absolute neutrophil count | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0079459
UMLS CUI [3]
C0079460
patients with hemoglobin < 80 g/l despite transfusion.
Description

Hemoglobin measurement | Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C1879316
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Multiple Myeloma NCT00570180

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
patients previously diagnosed with mm based on criteria from the international myeloma working group (imwg)
boolean
C0026764 (UMLS CUI [1])
Measurable Disease
Item
patients who have 'measurable' disease
boolean
C1513041 (UMLS CUI [1])
Age | Informed Consent
Item
age 18 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Therapeutic procedure Additional Multiple Myeloma | Remission Induction Therapy | Study Subject Participation Status
Item
a patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed on the current regimen and the other eligibility criteria are met.
boolean
C0087111 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C1514832 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
t(4;14) Positive
Item
patient is t(4;14) positive on screening assay.
boolean
C2986942 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pharmacotherapy | Adrenal Cortex Hormones | Prednisone U/day | Therapeutic procedure Myeloma | Therapeutic radiology procedure Excluded | Remission Induction Therapy Excluded
Item
concomitant therapy medications that include corticosteroids (> 10 mg per day of prednisone or equivalent) or other therapy that is or may be active against myeloma prior to day 1 (with the exception of radiation therapy or induction therapy as described under the above inclusion criteria section
boolean
C0013216 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0032952 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0026764 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C2828389 (UMLS CUI [5,2])
C1514832 (UMLS CUI [6,1])
C2828389 (UMLS CUI [6,2])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy of grade 2 or greater.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Mucosal bleeding | Internal hemorrhage | Platelet Transfusion refractory | Platelet count Maintenance Unable
Item
patients with evidence of mucosal or internal bleeding and/or refractoriness to platelet transfusions (i.e., unable to maintain a platelet count 50 x 109 /l).
boolean
C2748540 (UMLS CUI [1])
C1390214 (UMLS CUI [2])
C0086818 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C1287267 (UMLS CUI [4,1])
C0024501 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Absolute neutrophil count | Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor
Item
patients with an absolute neutrophil count (anc) < 1.0 x 109/l. treatment to raise the anc, such as granulocyte colony-stimulating factor (g-csf) or granulocyte-macrophage colony-stimulating factor (gm-csf) is not allowed within 14 days of study entry.
boolean
C0948762 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
C0079460 (UMLS CUI [3])
Hemoglobin measurement | Transfusion
Item
patients with hemoglobin < 80 g/l despite transfusion.
boolean
C0518015 (UMLS CUI [1])
C1879316 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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