ID

18192

Description

UARK 2003-25: A Study of Intravenous (IV) Busulfan (Busulfex®) in Multiple Myeloma Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00113919

Link

https://clinicaltrials.gov/show/NCT00113919

Keywords

Versions (1)
  1. 10/24/16 10/24/16 -
Uploaded on

October 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00113919

English

Eligibility Multiple Myeloma NCT00113919

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have symptomatic multiple myeloma requiring treatment
Description

Multiple Myeloma Symptomatic Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
patients must have been approved for single or tandem autologous transplant
Description

Single Autologous Transplantation Approved | Double Autologous Transplantation Approved

Data type

boolean

Alias
UMLS CUI [1,1]
C0040736
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0205540
UMLS CUI [2,1]
C0040736
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C0205540
patients must be > or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine > 3 mg/dl or a creatinine clearance < 30 ml/minute
Description

Age | Renal Insufficiency | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0373595
patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > 50% of predicted,
Description

Chronic Obstructive Airway Disease | Restrictive pulmonary disease chronic | Pulmonary function tests | FEV1 | FVC | DLCO

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2,1]
C0877013
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0024119
UMLS CUI [4]
C0748133
UMLS CUI [5]
C1287681
UMLS CUI [6]
C1516251
patients must have an echo or muga performed within 60 days prior to registration, lvef > 40%.
Description

Left ventricular ejection fraction | Echocardiography | MUGA

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0521317
bilirubin, sgot, sgpt must be less than 1.5 times the upper limit of normal
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
patients must have evaluable myeloma marker for response such as: *serum m protein >1g/dl or urine m protein >1g/24 hours and/or; *bone marrow plasmacytosis with >20% plasma cells and/or; *extramedullary plasmacytosis; *mri/pet scan has focal lesions due to myeloma.
Description

Disease Response | M Protein Serum | M Protein In Urine | BONE MARROW PLASMACYTOSIS | Plasma Cells Percentage | Plasmacytosis Extramedullary | Lesion Focal Due to Multiple Myeloma | Magnetic Resonance Imaging | Positron-Emission Tomography

Data type

boolean

Alias
UMLS CUI [1]
C1704632
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0229671
UMLS CUI [3,1]
C0700271
UMLS CUI [3,2]
C0042037
UMLS CUI [4]
C0238803
UMLS CUI [5,1]
C0032112
UMLS CUI [5,2]
C0439165
UMLS CUI [6,1]
C0085663
UMLS CUI [6,2]
C1517060
UMLS CUI [7,1]
C0221198
UMLS CUI [7,2]
C0205234
UMLS CUI [7,3]
C0678226
UMLS CUI [7,4]
C0026764
UMLS CUI [8]
C0024485
UMLS CUI [9]
C0032743
patients must be able to receive full doses of dt-pace, in the opinion of the treating investigator, with the exception of cisplatin.
Description

DT PACE regimen Ability | Cisplatin

Data type

boolean

Alias
UMLS CUI [1,1]
C1880242
UMLS CUI [1,2]
C0085732
UMLS CUI [2]
C0008838
patients must have a performance status of 0-2 based on swog criteria unless the patient's status is due to active myeloma
Description

performance status | Patient status Due to Multiple Myeloma

Data type

boolean

Alias
UMLS CUI [1]
C1518965
UMLS CUI [2,1]
C0449437
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0026764
all patients must be informed of the investigational nature of the study and have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
serum transaminases > 1.5 x uln and direct bilirubin > 1.5 mg/dl
Description

Serum transaminase increased | Bilirubin, direct measurement

Data type

boolean

Alias
UMLS CUI [1]
C0859350
UMLS CUI [2]
C0201916
hiv positive or active hepatitis b or hepatitis c infection; (if serology is positive a quantitative pcr will be done).
Description

HIV Seropositivity | Hepatitis B | Hepatitis C | Serology positive Causing Quantitative PCR analysis

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4,1]
C0242089
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C2733022
patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. patients must not currently be receiving therapy for the prior malignancy.
Description

Life Expectancy Due to Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0006826
pregnant or nursing women. women of childbearing potential must have a negative pregnancy test 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 | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C0015895
UMLS CUI [4,2]
C0700589
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Similar models

Eligibility Multiple Myeloma NCT00113919

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma Symptomatic Requirement Therapeutic procedure
Item
patients must have symptomatic multiple myeloma requiring treatment
boolean
C0026764 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Single Autologous Transplantation Approved | Double Autologous Transplantation Approved
Item
patients must have been approved for single or tandem autologous transplant
boolean
C0040736 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0205540 (UMLS CUI [1,3])
C0040736 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0205540 (UMLS CUI [2,3])
Age | Renal Insufficiency | Creatinine measurement, serum | Creatinine clearance measurement
Item
patients must be > or = 65 years of age or diagnosed with renal insufficiency, defined as having a creatinine > 3 mg/dl or a creatinine clearance < 30 ml/minute
boolean
C0001779 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
Chronic Obstructive Airway Disease | Restrictive pulmonary disease chronic | Pulmonary function tests | FEV1 | FVC | DLCO
Item
patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease. patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (fev1, fvc, etc) and diffusion capacity (dlco) > 50% of predicted,
boolean
C0024117 (UMLS CUI [1])
C0877013 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0024119 (UMLS CUI [3])
C0748133 (UMLS CUI [4])
C1287681 (UMLS CUI [5])
C1516251 (UMLS CUI [6])
Left ventricular ejection fraction | Echocardiography | MUGA
Item
patients must have an echo or muga performed within 60 days prior to registration, lvef > 40%.
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
bilirubin, sgot, sgpt must be less than 1.5 times the upper limit of normal
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Disease Response | M Protein Serum | M Protein In Urine | BONE MARROW PLASMACYTOSIS | Plasma Cells Percentage | Plasmacytosis Extramedullary | Lesion Focal Due to Multiple Myeloma | Magnetic Resonance Imaging | Positron-Emission Tomography
Item
patients must have evaluable myeloma marker for response such as: *serum m protein >1g/dl or urine m protein >1g/24 hours and/or; *bone marrow plasmacytosis with >20% plasma cells and/or; *extramedullary plasmacytosis; *mri/pet scan has focal lesions due to myeloma.
boolean
C1704632 (UMLS CUI [1])
C0700271 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
C0700271 (UMLS CUI [3,1])
C0042037 (UMLS CUI [3,2])
C0238803 (UMLS CUI [4])
C0032112 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C0085663 (UMLS CUI [6,1])
C1517060 (UMLS CUI [6,2])
C0221198 (UMLS CUI [7,1])
C0205234 (UMLS CUI [7,2])
C0678226 (UMLS CUI [7,3])
C0026764 (UMLS CUI [7,4])
C0024485 (UMLS CUI [8])
C0032743 (UMLS CUI [9])
DT PACE regimen Ability | Cisplatin
Item
patients must be able to receive full doses of dt-pace, in the opinion of the treating investigator, with the exception of cisplatin.
boolean
C1880242 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
performance status | Patient status Due to Multiple Myeloma
Item
patients must have a performance status of 0-2 based on swog criteria unless the patient's status is due to active myeloma
boolean
C1518965 (UMLS CUI [1])
C0449437 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
Informed Consent
Item
all patients must be informed of the investigational nature of the study and have signed an irb-approved informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Serum transaminase increased | Bilirubin, direct measurement
Item
serum transaminases > 1.5 x uln and direct bilirubin > 1.5 mg/dl
boolean
C0859350 (UMLS CUI [1])
C0201916 (UMLS CUI [2])
HIV Seropositivity | Hepatitis B | Hepatitis C | Serology positive Causing Quantitative PCR analysis
Item
hiv positive or active hepatitis b or hepatitis c infection; (if serology is positive a quantitative pcr will be done).
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0242089 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C2733022 (UMLS CUI [4,3])
Life Expectancy Due to Malignant Neoplasms
Item
patients with a prior malignancy in whom life expectancy is more likely to be determined by the prior malignancy than the myeloma. patients must not currently be receiving therapy for the prior malignancy.
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Fertility Contraceptive methods
Item
pregnant or nursing women. women of childbearing potential must have a negative pregnancy test 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])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0015895 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
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