ID

21440

Descripción

Study of XL999 in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00304590

Link

https://clinicaltrials.gov/show/NCT00304590

Palabras clave

  1. 21/4/17 21/4/17 -
Subido en

21 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00304590

Eligibility Multiple Myeloma NCT00304590

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Descripción

Multiple myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0026764
measurable disease defined as serum and/or urine m component by electrophoresis
Descripción

M component

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2363751
refractory to or relapsed after 2 prior treatment regimens (chemotherapy, biologic or hematopoietic stem cell transplantation)
Descripción

Refractory or relapsed disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205269
UMLS CUI [2]
C0277556
concurrent therapy with a bisphosphonate is acceptable
Descripción

Bisphosphonate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012544
ecog performance status of 0 or 1
Descripción

ECOG Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy ≥3 months
Descripción

Life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
adequate liver function
Descripción

Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
no other malignancies within 5 years
Descripción

Prior malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2735088
signed informed consent
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
nonsecretory myeloma, monoclonal gammopathy of uncertain significance (mgus), or smoldering myeloma
Descripción

Nonsecretory myeloma, MGUS, smoldering myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0456845
UMLS CUI [2]
C0026470
UMLS CUI [3]
C1531608
anticancer therapy including chemotherapeutic, biologic, or investigational agents, including dexamethasone, within 30 days of xl999 treatment
Descripción

Antineoplastic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2346834
hematopoietic stem cell transplantation within the previous 6 weeks
Descripción

Hematopoietic stem cell transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1504389
radiation to ≥33% of bone marrow within 30 days of xl999 treatment
Descripción

Bone marrow radiation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
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
Descripción

Adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
uncontrolled and/or intercurrent illness
Descripción

Comorbidity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or breastfeeding females
Descripción

Gynaecological status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known hiv
Descripción

HIV infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693

Similar models

Eligibility Multiple Myeloma NCT00304590

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
HIV infection
Item
known hiv
boolean
C0019693 (UMLS CUI [1])

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