Information:
Fel:
ID
21440
Beskrivning
Study of XL999 in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00304590
Länk
https://clinicaltrials.gov/show/NCT00304590
Nyckelord
Versioner (1)
- 2017-04-21 2017-04-21 -
Uppladdad den
21 april 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00304590
Eligibility Multiple Myeloma NCT00304590
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Myeloma NCT00304590
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Multiple myeloma
Item
males and females with a diagnosis of mm based on bone marrow aspirate and biopsy with ≥10% plasma cells (or biopsy of a tissue with monoclonal plasma cells), m protein level in the serum or urine, and evidence of end organ or tissue impairment (hypercalcemia, renal insufficiency, anemia, or lytic bone lesions), as defined by the international myeloma working group criteria (2003), at initial diagnosis (before initiation of chemotherapy)
boolean
C0026764 (UMLS CUI [1])
M component
Item
measurable disease defined as serum and/or urine m component by electrophoresis
boolean
C2363751 (UMLS CUI [1])
Refractory or relapsed disease
Item
refractory to or relapsed after 2 prior treatment regimens (chemotherapy, biologic or hematopoietic stem cell transplantation)
boolean
C0205269 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0277556 (UMLS CUI [2])
Bisphosphonate
Item
concurrent therapy with a bisphosphonate is acceptable
boolean
C0012544 (UMLS CUI [1])
ECOG Performance Status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life expectancy
Item
life expectancy ≥3 months
boolean
C0023671 (UMLS CUI [1])
Liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
Prior malignancy
Item
no other malignancies within 5 years
boolean
C2735088 (UMLS CUI [1])
Informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Nonsecretory myeloma, MGUS, smoldering myeloma
Item
nonsecretory myeloma, monoclonal gammopathy of uncertain significance (mgus), or smoldering myeloma
boolean
C0456845 (UMLS CUI [1])
C0026470 (UMLS CUI [2])
C1531608 (UMLS CUI [3])
C0026470 (UMLS CUI [2])
C1531608 (UMLS CUI [3])
Antineoplastic therapy
Item
anticancer therapy including chemotherapeutic, biologic, or investigational agents, including dexamethasone, within 30 days of xl999 treatment
boolean
C2346834 (UMLS CUI [1])
Hematopoietic stem cell transplantation
Item
hematopoietic stem cell transplantation within the previous 6 weeks
boolean
C1504389 (UMLS CUI [1])
Bone marrow radiation
Item
radiation to ≥33% of bone marrow within 30 days of xl999 treatment
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
Adverse event
Item
subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs that were administered >30 prior to study enrollment
boolean
C0877248 (UMLS CUI [1])
Comorbidity
Item
uncontrolled and/or intercurrent illness
boolean
C0009488 (UMLS CUI [1])
Gynaecological status
Item
pregnant or breastfeeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
HIV infection
Item
known hiv
boolean
C0019693 (UMLS CUI [1])