ID

13064

Description

D.T. PACE Versus High Dose Melphalan and Autologous Transplant in Patients With Previously Treated Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00083876

Link

https://clinicaltrials.gov/show/NCT00083876

Keywords

Versions (1)
  1. 1/14/16 1/14/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 14, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Multiple Myeloma NCT00083876

English

Eligibility Multiple Myeloma NCT00083876

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have previously treated (> 1 cycle prior therapy), active multiple myeloma requiring treatment. patients that have received >450 mg/m2 of prior adriamycin therapy are eligible, however, adriamycin will be deleted from the dt pace regimen in these patients.
Description

multiple myeloma

Data type

boolean

Alias
UMLS CUI [1]
C0026764
patients must have measurable disease defined as one of the following: serum monoclonal protein >/= 1.0 mg/dl, or urine monoclonal protein >/= 1.0 grams/24 hour, or >/= 20% bone marrow plasmacytosis.
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C2984963
UMLS CUI [2]
C0085663
all necessary baseline studies for determining eligibility must be obtained within 35 days prior to registration.
Description

eligibility

Data type

boolean

Alias
UMLS CUI [1]
C0013893
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 must have a platelet count > or = 100,000/microliters. patients with platelet count < 100,000/microliters may be enrolled if it is felt to be due to extensive marrow plasmacytosis. the study coordinator must be consulted and dose modifications may apply.
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0005821
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

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have received a prior autotransplant or allograft.
Description

autotransplant or allograft

Data type

boolean

Alias
UMLS CUI [1]
C0472699
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
Description

co-morbid medical conditions

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with recent (< o= 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.patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > or = 50% of predicted. patients unable to complete pulmonary function tests due to myeloma related pain or fracture must have a high resolution ct scan of the chest and must also have acceptable arterial blood gases defined as p02 greater than 70.
Description

pulmonary diseases

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0024119
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

prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
pregnant or nursing women may not participate. women of childbearing 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 an 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 NCT00083876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
multiple myeloma
Item
patients must have previously treated (> 1 cycle prior therapy), active multiple myeloma requiring treatment. patients that have received >450 mg/m2 of prior adriamycin therapy are eligible, however, adriamycin will be deleted from the dt pace regimen in these patients.
boolean
C0026764 (UMLS CUI [1])
measurable disease
Item
patients must have measurable disease defined as one of the following: serum monoclonal protein >/= 1.0 mg/dl, or urine monoclonal protein >/= 1.0 grams/24 hour, or >/= 20% bone marrow plasmacytosis.
boolean
C2984963 (UMLS CUI [1])
C0085663 (UMLS CUI [2])
eligibility
Item
all necessary baseline studies for determining eligibility must be obtained within 35 days prior to registration.
boolean
C0013893 (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])
platelet count
Item
patients must have a platelet count > or = 100,000/microliters. patients with platelet count < 100,000/microliters may be enrolled if it is felt to be due to extensive marrow plasmacytosis. the study coordinator must be consulted and dose modifications may apply.
boolean
C0005821 (UMLS CUI [1])
written 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])
Item Group
C0680251 (UMLS CUI)
autotransplant or allograft
Item
patients must not have received a prior autotransplant or allograft.
boolean
C0472699 (UMLS CUI [1])
co-morbid medical conditions
Item
patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection.
boolean
C0009488 (UMLS CUI [1])
cardiac disease
Item
patients with recent (< o= 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 diseases
Item
patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease.patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > or = 50% of predicted. patients unable to complete pulmonary function tests due to myeloma related pain or fracture must have a high resolution ct scan of the chest and must also have acceptable arterial blood gases defined as p02 greater than 70.
boolean
C0024115 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
prior 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 childbearing 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 an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
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