Eligibility Multiple Myeloma NCT00577668

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StudyEvent: Eligibility
1. Eligibility Multiple Myeloma NCT00577668

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Multiple Myeloma | Transplantation Twice Scheduled | Autologous Transplantation Scheduled | Recurrent disease | Progressive Disease

Item

history of histologically documented mm with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.

boolean

C0026764 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C1948050 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0040736 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
C1335499 (UMLS CUI [5])

Measurable Disease

Item

patient has measurable disease in which to capture response.

boolean

C1513041 (UMLS CUI [1])

Zubrod Performance Status | Bone pain Zubrod Performance Status

Item

performance status of 2 as per zubroid scale, unless ps of 3-4 based solely on bone pain.

boolean

C3714786 (UMLS CUI [1])
C0151825 (UMLS CUI [2,1])
C3714786 (UMLS CUI [2,2])

Platelet Count measurement | Absolute neutrophil count

Item

patients must have a platelet count 75,000/μl, and an anc of at least 1,000/μl.

boolean

C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])

Renal function | Creatinine measurement, serum

Item

patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.

boolean

C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])

Liver function | Transaminase Assay | Bilirubin, direct measurement

Item

patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.

boolean

C0232741 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
C0201916 (UMLS CUI [3])

Pregnancy Exclusion | Breast Feeding Exclusion | Childbearing Potential Pregnancy test negative | Childbearing 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. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

boolean

C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])

Age

Item

male or female adults of at least 18 years of age.

boolean

C0001779 (UMLS CUI [1])

Informed Consent | Protocol Compliance

Item

patients must have signed an irb-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.

boolean

C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Chemotherapy | Therapeutic radiology procedure

Item

chemotherapy or radiotherapy received within the previous 2 weeks.

boolean

C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])

Neurotoxicity CTCAE Grades

Item

significant neurotoxicity, defined as grade > 2 neurotoxicity per nci common toxicity criteria (see appendix).

boolean

C0235032 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])

Platelet Count measurement | Absolute neutrophil count

Item

platelet count < 75,000/mm3, or anc < 1,000/μl.

boolean

C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])

Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Hepatitis

Item

clinically significant hepatic dysfunction as noted by bilirubin or ast > 3 times the upper normal limit or clinically significant concurrent hepatitis.

boolean

C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0019158 (UMLS CUI [4])

Heart failure New York Heart Association Classification

Item

new york hospital association (nyha) class iii or class iv heart failure.

boolean

C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])

Myocardial Infarction

Item

myocardial infarction within the last 6 months.

boolean

C0027051 (UMLS CUI [1])

Communicable Disease Uncontrolled | Intravenous antibiotic therapy Patient need for

Item

uncontrolled, active infection requiring iv antibiotics.

boolean

C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0559680 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])

Therapeutic procedure Ventricular arrhythmia

Item

patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.

boolean

C0087111 (UMLS CUI [1,1])
C0085612 (UMLS CUI [1,2])

Poor hypertension control | Diabetes Mellitus | Illness Serious Interferes with Treatment completion | Mental disorder Interferes with Treatment completion

Item

poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.

boolean

C0421190 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0580352 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])

Pregnancy | Gender Fertility | Childbearing Potential Pregnancy Test Contraceptive methods

Item

pregnant or potential for pregnancy. women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method.

boolean

C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0015895 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])

Breast Feeding

Item

breast-feeding women may not participate.

boolean

C0006147 (UMLS CUI [1])

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Eligibility Multiple Myeloma NCT00577668