ID

21470

Beschreibung

UARK 2006-66, Total Therapy 3B: An Extension of UARK 2003-33 Total Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00572169

Link

https://clinicaltrials.gov/show/NCT00572169

Stichworte

Versionen (1)
  1. 23.04.17 23.04.17 -
Hochgeladen am

23. April 2017

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00572169

Englisch

Eligibility Multiple Myeloma NCT00572169

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have newly diagnosed active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
Beschreibung

Multiple myeloma requiring treatment, smoldering myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1830593
UMLS CUI [2]
C1531608
protein criteria must be present (quantifiable serum m-component of igg, iga, igd, or ige; urinary kappa or lambda light chain; or serum free light chain (sflc) levels in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas or focal lesions on mri or diffuse hyperintense signal on stir images in the absence of hematopoietic growth factors.
Beschreibung

Myeloma proteins

Datentyp

boolean

Alias
UMLS CUI [1]
C0027015
patients must have received no more than one cycle or one month of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
Beschreibung

Prior chemotherapy or radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
patients must be <75 years of age at the time of initial registration.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ejection fraction by echo or muga ≥ 40% performed within 60 days prior to registration.
Beschreibung

Ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0489482
patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > 50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy.
Beschreibung

Pulmonary function

Datentyp

boolean

Alias
UMLS CUI [1]
C0231921
patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
Beschreibung

Performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
platelet count < 30 x 109/l, unless myeloma-related.
Beschreibung

Platelets

Datentyp

boolean

Alias
UMLS CUI [1]
C0005821
5.1.2.2 grade > 2 peripheral neuropathy.
Beschreibung

Neuropathy grade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0441800
hypersensitivity to bortezomib, boron, or mannitol.
Beschreibung

Hypersensitivity to bortezomib, boron, or mannitol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176309
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0006030
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0024730
uncontrolled diabetes.
Beschreibung

Uncontrolled diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205318
recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
Beschreibung

Cardiac status

Datentyp

boolean

Alias
UMLS CUI [1]
C1999091
evidence of chronic obstructive or chronic restrictive pulmonary disease.
Beschreibung

Chronic obstructive or chronic restrictive pulmonary disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0877013
patients must not have light chain deposition disease or creatinine > 3 mg/dl
Beschreibung

Light chain deposition disease or creatinine

Datentyp

boolean

Alias
UMLS CUI [1]
C0238239
UMLS CUI [2]
C0201976
patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. other cancers will only be acceptable if the patient's life expectancy exceeds five years.
Beschreibung

Prior malignancy or life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0023671
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Beschreibung

Gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00572169

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple myeloma requiring treatment, smoldering myeloma
Item
patients must have newly diagnosed active mm requiring treatment. patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
boolean
C0026764 (UMLS CUI [1,1])
C1830593 (UMLS CUI [1,2])
C1531608 (UMLS CUI [2])
Myeloma proteins
Item
protein criteria must be present (quantifiable serum m-component of igg, iga, igd, or ige; urinary kappa or lambda light chain; or serum free light chain (sflc) levels in order to evaluate response. non-secretory patients are eligible provided the patient has > 20% plasmacytosis or multiple (>3) focal plasmacytomas or focal lesions on mri or diffuse hyperintense signal on stir images in the absence of hematopoietic growth factors.
boolean
C0027015 (UMLS CUI [1])
Prior chemotherapy or radiotherapy
Item
patients must have received no more than one cycle or one month of prior chemotherapy for this disease. patients may have received prior radiotherapy provided approval has been obtained by the principal investigator.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Age
Item
patients must be <75 years of age at the time of initial registration.
boolean
C0001779 (UMLS CUI [1])
Ejection fraction
Item
ejection fraction by echo or muga ≥ 40% performed within 60 days prior to registration.
boolean
C0489482 (UMLS CUI [1])
Pulmonary function
Item
patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > 50% of predicted, within 60 days of registration. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy.
boolean
C0231921 (UMLS CUI [1])
Performance status
Item
patients must have a performance status of 0-2 based on swog criteria. patients with a poor performance status (3-4), based solely on bone pain, will be eligible.
boolean
C1518965 (UMLS CUI [1])
Informed consent
Item
all patients must be informed of the investigational nature of this study and must have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Platelets
Item
platelet count < 30 x 109/l, unless myeloma-related.
boolean
C0005821 (UMLS CUI [1])
Neuropathy grade
Item
5.1.2.2 grade > 2 peripheral neuropathy.
boolean
C0442874 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Hypersensitivity to bortezomib, boron, or mannitol
Item
hypersensitivity to bortezomib, boron, or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0006030 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0024730 (UMLS CUI [3,2])
Uncontrolled diabetes mellitus
Item
uncontrolled diabetes.
boolean
C0011849 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cardiac status
Item
recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias.
boolean
C1999091 (UMLS CUI [1])
Chronic obstructive or chronic restrictive pulmonary disease
Item
evidence of chronic obstructive or chronic restrictive pulmonary disease.
boolean
C0024117 (UMLS CUI [1])
C0877013 (UMLS CUI [2])
Light chain deposition disease or creatinine
Item
patients must not have light chain deposition disease or creatinine > 3 mg/dl
boolean
C0238239 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Prior malignancy or life expectancy
Item
patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. other cancers will only be acceptable if the patient's life expectancy exceeds five years.
boolean
C2735088 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Comorbidity
Item
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
boolean
C0009488 (UMLS CUI [1])
Gynaecological status
Item
pregnant or nursing women. women of child-bearing potential must have a negative pregnancy test documented within one week of registration. women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
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