ID

16954

Descripción

Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00375791

Link

https://clinicaltrials.gov/show/NCT00375791

Palabras clave

Versiones (2)
  1. 16/8/16 16/8/16 -
  2. 16/8/16 16/8/16 - Julian Varghese
Subido en

16 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00375791

Inglés

Eligibility Multiple Myeloma NCT00375791

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. plasmacytomas on tissue biopsy.
Descripción

Criteria 1-3 are major criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032131
2. bone marrow plasmacytosis (> 30% plasma cells).
Descripción

Bone marrow plasmacytosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0238803
3. monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin g (igg) > 3.5 g/dl or immunoglobulin a (iga) > 2.0 g/dl; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
Descripción

monoclonal immunoglobulin spike, IgG, IgA, kappa or lambda light chain excretion on 24 hour urine protein electrophoresis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0860896
UMLS CUI [2]
C0202087
UMLS CUI [3]
C0202083
UMLS CUI [4,1]
C0021036
UMLS CUI [4,2]
C2321676
UMLS CUI [5,1]
C0021037
UMLS CUI [5,2]
C2321676
minor criteria:
Descripción

Minor criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0205165
1. bone marrow plasmacytosis (10 to 30% plasma cells)
Descripción

following criteria 1. -4. are minor criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0238803
2. monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
Descripción

Monoclonal immunoglobulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700271
3. lytic bone lesions
Descripción

Lytic bone lesions

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0221204
4. normal immunoglobulin m (igm) < 50 mg/dl, iga < 100 mg/dl or igg < 600 mg/dl.
Descripción

IgM, IgA, IgG

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202084
UMLS CUI [2]
C0202083
UMLS CUI [3]
C0202087
any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
Descripción

following sets of criteria will confirm the diagnosis of multiple myeloma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0750484
1. any two of the major criteria.
Descripción

Eligibility Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
2. major criterion 1 plus minor criterion b, c or d.
Descripción

Eligibility Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
3. major criterion 3 plus minor criterion a or c.
Descripción

Eligibility Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
4. minor criteria a, b and c or a, b and d.
Descripción

Eligibility Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. renal insufficiency (serum creatinine levels > 3 mg/dl).
Descripción

Renal insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
2. patients who present with either alt or ast ≥ 2.5 x upper limit of normal.
Descripción

ALT/AST

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
Descripción

Hypersensitivity to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0754570
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0068006
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0044549
4. concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to day 1. nitrosoureas must be discontinued 6 weeks prior to day 1.
Descripción

Corticosteroids, other chemotherapy, nitrosoureas

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0028210
5. subjects with a hemoglobin < 8.0 g/dl.
Descripción

Hb

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0518015
6. any condition, including laboratory abnormalities, that in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
Descripción

Any condition that places the subject at unacceptable risk if they were to participate in the study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
7. women of childbearing potential (wcbp) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
Descripción

Pregnant or breast feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
8. plasma cell leukemia.
Descripción

Plasma cell leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023484
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Similar models

Eligibility Multiple Myeloma NCT00375791

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Plasmacytomas
Item
1. plasmacytomas on tissue biopsy.
boolean
C0032131 (UMLS CUI [1])
Bone marrow plasmacytosis
Item
2. bone marrow plasmacytosis (> 30% plasma cells).
boolean
C0238803 (UMLS CUI [1])
monoclonal immunoglobulin spike, IgG, IgA, kappa or lambda light chain excretion on 24 hour urine protein electrophoresis
Item
3. monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin g (igg) > 3.5 g/dl or immunoglobulin a (iga) > 2.0 g/dl; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
boolean
C0860896 (UMLS CUI [1])
C0202087 (UMLS CUI [2])
C0202083 (UMLS CUI [3])
C0021036 (UMLS CUI [4,1])
C2321676 (UMLS CUI [4,2])
C0021037 (UMLS CUI [5,1])
C2321676 (UMLS CUI [5,2])
Minor criteria
Item
minor criteria:
boolean
C1516637 (UMLS CUI [1,1])
C0205165 (UMLS CUI [1,2])
Bone marrow plasmacytosis
Item
1. bone marrow plasmacytosis (10 to 30% plasma cells)
boolean
C0238803 (UMLS CUI [1])
Monoclonal immunoglobulin
Item
2. monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
boolean
C0700271 (UMLS CUI [1])
Lytic bone lesions
Item
3. lytic bone lesions
boolean
C0221204 (UMLS CUI [1])
IgM, IgA, IgG
Item
4. normal immunoglobulin m (igm) < 50 mg/dl, iga < 100 mg/dl or igg < 600 mg/dl.
boolean
C0202084 (UMLS CUI [1])
C0202083 (UMLS CUI [2])
C0202087 (UMLS CUI [3])
following sets of criteria will confirm the diagnosis of multiple myeloma
Item
any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
boolean
C0026764 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Eligibility Criteria
Item
1. any two of the major criteria.
boolean
C1516637 (UMLS CUI [1])
Eligibility Criteria
Item
2. major criterion 1 plus minor criterion b, c or d.
boolean
C1516637 (UMLS CUI [1])
Eligibility Criteria
Item
3. major criterion 3 plus minor criterion a or c.
boolean
C1516637 (UMLS CUI [1])
Eligibility Criteria
Item
4. minor criteria a, b and c or a, b and d.
boolean
C1516637 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Renal insufficiency
Item
1. renal insufficiency (serum creatinine levels > 3 mg/dl).
boolean
C0201976 (UMLS CUI [1])
ALT/AST
Item
2. patients who present with either alt or ast ≥ 2.5 x upper limit of normal.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Hypersensitivity to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine)
Item
3. history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
boolean
C0020517 (UMLS CUI [1,1])
C0754570 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0068006 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0044549 (UMLS CUI [3,2])
Corticosteroids, other chemotherapy, nitrosoureas
Item
4. concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to day 1. nitrosoureas must be discontinued 6 weeks prior to day 1.
boolean
C0038317 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
Hb
Item
5. subjects with a hemoglobin < 8.0 g/dl.
boolean
C0518015 (UMLS CUI [1])
Any condition that places the subject at unacceptable risk if they were to participate in the study
Item
6. any condition, including laboratory abnormalities, that in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Pregnant or breast feeding
Item
7. women of childbearing potential (wcbp) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Plasma cell leukemia
Item
8. plasma cell leukemia.
boolean
C0023484 (UMLS CUI [1])
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