ID

13059

Description

TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00083551

Link

https://clinicaltrials.gov/show/NCT00083551

Keywords

Versions (1)
  1. 1/13/16 1/13/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 13, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT00083551

English

Eligibility Multiple Myeloma NCT00083551

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
protein criteria must be present in order to evaluate response.non-secretory patients are eligible provided the patient has > or = 20% plasmacytosis or multiple (>3) focal plasmacytomas on mri or diffuse hyperintense signal on stir images in the absence of hematopoietic growth factors is seen.
Description

proteinuria

Data type

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2]
C0085663
all necessary baseline studies for determining stage, bloodwork, and bone marrow must be obtained within 35 days prior to registration.
Description

stage, bloodwork, and bone marrow

Data type

boolean

Alias
UMLS CUI [1]
C0430022
patients must have received no more than one cycle of prior chemotherapy including one month of dexamethasone and thalidomide for this disease. patients may have received prior radiotherapy provided approval has been obtained by one of the study coordinators.
Description

chemotherapy, radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
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.
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
patients with renal failure, even if on dialysis, are eligible if it is felt to be due to myeloma and if the duration of renal failure does not exceed two months
Description

renal failure

Data type

boolean

Alias
UMLS CUI [1]
C0035078
patients must be 75 years of age or less at the time of registration
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
if medically appropriate, patients with pathologic fractures, pneumonia at diagnosis or hyperviscosity with shortness of breath should have these conditions attended to prior to registration.
Description

pathologic fractures, pneumonia at diagnosis or hyperviscosity with shortness of breath

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection
Description

patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients must not have uncontrolled diabetes
Description

diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011849
patients with recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. ejection fraction by echo or muga should be within the institutional normal range and must be performed within 42 days prior to registration.
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0232174
patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease.
Description

pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
no prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval and there must be no prior treatment with cytotoxic drugs that could potentially be assigned on this treatment protocol.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
pregnant or nursing women may not participate. women of child-bearing potential must have a negative pregnancy documented within one week of registration. women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method.
Description

pregnancy, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
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Similar models

Eligibility Multiple Myeloma NCT00083551

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma
Item
patients must have newly diagnosed active multiple myeloma 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])
proteinuria
Item
protein criteria must be present in order to evaluate response.non-secretory patients are eligible provided the patient has > or = 20% plasmacytosis or multiple (>3) focal plasmacytomas on mri or diffuse hyperintense signal on stir images in the absence of hematopoietic growth factors is seen.
boolean
C0033687 (UMLS CUI [1])
C0085663 (UMLS CUI [2])
stage, bloodwork, and bone marrow
Item
all necessary baseline studies for determining stage, bloodwork, and bone marrow must be obtained within 35 days prior to registration.
boolean
C0430022 (UMLS CUI [1])
chemotherapy, radiotherapy
Item
patients must have received no more than one cycle of prior chemotherapy including one month of dexamethasone and thalidomide for this disease. patients may have received prior radiotherapy provided approval has been obtained by one of the study coordinators.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
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])
renal failure
Item
patients with renal failure, even if on dialysis, are eligible if it is felt to be due to myeloma and if the duration of renal failure does not exceed two months
boolean
C0035078 (UMLS CUI [1])
age
Item
patients must be 75 years of age or less at the time of registration
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
all patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
pathologic fractures, pneumonia at diagnosis or hyperviscosity with shortness of breath
Item
if medically appropriate, patients with pathologic fractures, pneumonia at diagnosis or hyperviscosity with shortness of breath should have these conditions attended to prior to registration.
boolean
C0009488 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection
Item
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection
boolean
C0009488 (UMLS CUI [1])
diabetes
Item
patients must not have uncontrolled diabetes
boolean
C0011849 (UMLS CUI [1])
cardiac disease
Item
patients with recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. ejection fraction by echo or muga should be within the institutional normal range and must be performed within 42 days prior to registration.
boolean
C0018799 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
pulmonary disease
Item
patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease.
boolean
C0024115 (UMLS CUI [1])
malignancy
Item
no prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years.prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval and there must be no prior treatment with cytotoxic drugs that could potentially be assigned on this treatment protocol.
boolean
C0006826 (UMLS CUI [1])
pregnancy, contraception
Item
pregnant or nursing women may not participate. women of child-bearing potential must have a negative pregnancy documented within one week of registration. women/men of reproductive potential may not participate unless they have agreed to use two forms of effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
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