ID

30873

Description

A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission; ODM derived from: https://clinicaltrials.gov/show/NCT00869232

Lien

https://clinicaltrials.gov/show/NCT00869232

Mots-clés

Versions (1)
  1. 29/06/2018 29/06/2018 -
Détendeur de droits

See clinicaltrials.gov

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29 juin 2018

DOI

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Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00869232

Anglais

Eligibility Multiple Myeloma NCT00869232

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Multiple Myeloma Treatment required for | Smoldering myeloma | Progressive Disease Requirement Chemotherapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C1531608
UMLS CUI [3,1]
C1335499
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0392920
patients must be either untreated o have not had more than one cycle of systemic mm therapy, excluding bisphosphonates and localized radiation.
Description

Patients untreated | Systemic therapy Course Quantity Multiple Myeloma | Diphosphonates Excluded | Therapeutic radiology procedure Localized Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0026764
UMLS CUI [3,1]
C0012544
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0392752
UMLS CUI [4,3]
C0332196
patients must have high-risk disease, as defined by any one of the following:
Description

Disease High risk

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332167
gep risk score of > or = 0.66 or
Description

Gene Expression Profiling Risk Score

Type de données

boolean

Alias
UMLS CUI [1,1]
C0752248
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0449820
ldh > or = 360 u/l rule out hemolysis, infection an contact pi for clarification
Description

Lactate dehydrogenase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0202113
zubrod < or = 2, unless solely due to symptoms of mm-related bone disease.
Description

Zubrod Performance Status | Exception Bone Disease Relationship Multiple Myeloma

Type de données

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005940
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0026764
patients must have a platelet count of > or = 50,000/ul, unless lower levels are explained by extensive bone marrow plasmacytosis.
Description

Platelet Count measurement | Exception BONE MARROW PLASMACYTOSIS Extensive

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0238803
UMLS CUI [2,3]
C0205231
patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
participants must have preserved renal function as defined by a serum creatinine level of < 3 mg/dl.
Description

Renal function | Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
participants must have an ejection fraction by echo or muga scan > or = 45%
Description

Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan

Type de données

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (fev squared, fvc, etc) and diffusion capacity (dlco) > or = 50% of predicted. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted if the principle investigator documents that the patient is a candidate for high dose therapy.
Description

Pulmonary function tests | FEV1 | FVC | Carbon Monoxide Diffusing Capability Test

Type de données

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C0849974
UMLS CUI [3]
C3714541
UMLS CUI [4]
C1516251
patients must have signed an irb-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the irb.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
does not have high-risk disease
Description

Disease High risk Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0332197
poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
Description

Poor hypertension control | Diabetes mellitus poor control | Illness Serious Interferes with Treatment completion | Serious mental illness Interferes with Treatment completion

Type de données

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0860161
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0580352
UMLS CUI [4,1]
C3841614
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0580352
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.
Description

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasms untreated | Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C0332155
UMLS CUI [6]
C0023671
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy documented within one week of registration. subjects of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Description

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C4034483
UMLS CUI [4,2]
C0700589
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Similar models

Eligibility Multiple Myeloma NCT00869232

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Treatment required for | Smoldering myeloma | Progressive Disease Requirement Chemotherapy
Item
patients must have newly diagnosed active mm requiring treatment. patients with previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy.
boolean
C0026764 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1531608 (UMLS CUI [2])
C1335499 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Patients untreated | Systemic therapy Course Quantity Multiple Myeloma | Diphosphonates Excluded | Therapeutic radiology procedure Localized Excluded
Item
patients must be either untreated o have not had more than one cycle of systemic mm therapy, excluding bisphosphonates and localized radiation.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0026764 (UMLS CUI [2,4])
C0012544 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
Disease High risk
Item
patients must have high-risk disease, as defined by any one of the following:
boolean
C0012634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
Gene Expression Profiling Risk Score
Item
gep risk score of > or = 0.66 or
boolean
C0752248 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Lactate dehydrogenase measurement
Item
ldh > or = 360 u/l rule out hemolysis, infection an contact pi for clarification
boolean
C0202113 (UMLS CUI [1])
Zubrod Performance Status | Exception Bone Disease Relationship Multiple Myeloma
Item
zubrod < or = 2, unless solely due to symptoms of mm-related bone disease.
boolean
C3714786 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005940 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0026764 (UMLS CUI [2,4])
Platelet Count measurement | Exception BONE MARROW PLASMACYTOSIS Extensive
Item
patients must have a platelet count of > or = 50,000/ul, unless lower levels are explained by extensive bone marrow plasmacytosis.
boolean
C0032181 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0238803 (UMLS CUI [2,2])
C0205231 (UMLS CUI [2,3])
Age
Item
patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
boolean
C0001779 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
participants must have preserved renal function as defined by a serum creatinine level of < 3 mg/dl.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction MUGA scan
Item
participants must have an ejection fraction by echo or muga scan > or = 45%
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Pulmonary function tests | FEV1 | FVC | Carbon Monoxide Diffusing Capability Test
Item
patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (fev squared, fvc, etc) and diffusion capacity (dlco) > or = 50% of predicted. if the patient is unable to complete pulmonary function tests due to mm related pain or condition, exception may be granted if the principle investigator documents that the patient is a candidate for high dose therapy.
boolean
C0024119 (UMLS CUI [1])
C0849974 (UMLS CUI [2])
C3714541 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
Informed Consent
Item
patients must have signed an irb-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the irb.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Disease High risk Absent
Item
does not have high-risk disease
boolean
C0012634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Poor hypertension control | Diabetes mellitus poor control | Illness Serious Interferes with Treatment completion | Serious mental illness Interferes with Treatment completion
Item
poorly controlled hypertension, diabetes mellitus, or other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
boolean
C0421190 (UMLS CUI [1])
C0860161 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0580352 (UMLS CUI [3,4])
C3841614 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Malignant Neoplasms untreated | 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
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C0332155 (UMLS CUI [5,3])
C0023671 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods
Item
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy documented within one week of registration. subjects 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])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C4034483 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
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