ID

21894

Description

High -Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00349778

Link

https://clinicaltrials.gov/show/NCT00349778

Keywords

  1. 5/7/17 5/7/17 -
Uploaded on

May 7, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00349778

Eligibility Multiple Myeloma NCT00349778

Criteria
Description

Criteria

age 18-75 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have their pathology reviewed and the diagnosis confirmed at stanford university medical center. patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or primary amyloidosis will be excluded from this study. patients with multiple myeloma and amyloidosis may be eligible for this trial, with approval by the principle investigator.
Description

Smoldering myeloma Excluded | Monoclonal Gammopathy of Undetermined Significance Excluded | Primary amyloidosis Excluded | Multiple Myeloma | Amyloidosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1531608
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0026470
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0268381
UMLS CUI [3,2]
C2828389
UMLS CUI [4]
C0026764
UMLS CUI [5]
C0002726
patients must have a karnofsky performance status > 70%.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
dlco >=60% predicted.
Description

Carbon Monoxide Diffusing Capability Test

Data type

boolean

Alias
UMLS CUI [1]
C1516251
alt and ast must be < 2x normal. total bilirubin less than 2 mg/dl.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C1278039
serum creatinine < 2.0 or 24-hour creatinine clearance e 60 ml/min.
Description

Creatinine measurement, serum | 24 hour renal creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C4032392
patients must be hiv negative.
Description

HIV negative

Data type

boolean

Alias
UMLS CUI [1]
C0481430
pregnant or lactating women will not be eligible to participate.
Description

Pregnancy Excluded | Breast Feeding Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C2828389
patients must provide signed, informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria:- severe psychological or medical illness
Description

Exclusion Criteria | Mental disorder Severe | Illness Severe

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205082
patients who have undergone prior autologous hematopoietic cell transplantation will not be eligible for this study.
Description

autologous hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C2193200

Similar models

Eligibility Multiple Myeloma NCT00349778

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
age 18-75 years.
boolean
C0001779 (UMLS CUI [1])
Smoldering myeloma Excluded | Monoclonal Gammopathy of Undetermined Significance Excluded | Primary amyloidosis Excluded | Multiple Myeloma | Amyloidosis
Item
patients must have their pathology reviewed and the diagnosis confirmed at stanford university medical center. patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or primary amyloidosis will be excluded from this study. patients with multiple myeloma and amyloidosis may be eligible for this trial, with approval by the principle investigator.
boolean
C1531608 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0026470 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0268381 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0026764 (UMLS CUI [4])
C0002726 (UMLS CUI [5])
Karnofsky Performance Status
Item
patients must have a karnofsky performance status > 70%.
boolean
C0206065 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test
Item
dlco >=60% predicted.
boolean
C1516251 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
alt and ast must be < 2x normal. total bilirubin less than 2 mg/dl.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Creatinine measurement, serum | 24 hour renal creatinine clearance
Item
serum creatinine < 2.0 or 24-hour creatinine clearance e 60 ml/min.
boolean
C0201976 (UMLS CUI [1])
C4032392 (UMLS CUI [2])
HIV negative
Item
patients must be hiv negative.
boolean
C0481430 (UMLS CUI [1])
Pregnancy Excluded | Breast Feeding Excluded
Item
pregnant or lactating women will not be eligible to participate.
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Informed Consent
Item
patients must provide signed, informed consent.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria | Mental disorder Severe | Illness Severe
Item
exclusion criteria:- severe psychological or medical illness
boolean
C0680251 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0221423 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
autologous hematopoietic stem cell transplant
Item
patients who have undergone prior autologous hematopoietic cell transplantation will not be eligible for this study.
boolean
C2193200 (UMLS CUI [1])

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