ID

30845

Beschreibung

Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00555100

Link

https://clinicaltrials.gov/show/NCT00555100

Stichworte

Versionen (1)
  1. 26.06.18 26.06.18 -
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See clinicaltrials.gov

Hochgeladen am

26. Juni 2018

DOI

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Eligibility Multiple Myeloma NCT00555100

Englisch

Eligibility Multiple Myeloma NCT00555100

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with previously treated multiple myeloma
Beschreibung

Prior Therapy Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0026764
measurable levels of m-protein in serum >= 0.5 g/dl [5g/l]) or urine (>= 0.2 g excreted in a 24-hour collection sample)
Beschreibung

Serum M Protein Level Measurable | M Protein In Urine Level 24 hour urine sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0441889
UMLS CUI [1,4]
C1513040
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0042037
UMLS CUI [2,3]
C0441889
UMLS CUI [2,4]
C0456209
ecog performance status of 0 - 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
willing to follow pregnancy precautions
Beschreibung

Contraceptive methods Adherence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1510802
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with acute an myocardial infarction (mi) within the past 6 months, or patients with a history of deep vein thrombosis (dvt) or pulmonary embolism (pe) within the past 3 years
Beschreibung

Myocardial Infarction | Deep Vein Thrombosis | Pulmonary Embolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0034065
patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
Beschreibung

Tuberculosis | Keratitis, Herpetic | Systemic mycosis | Communicable Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2]
C0019357
UMLS CUI [3]
C0553576
UMLS CUI [4]
C0009450
patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
Beschreibung

Diabetic - poor control | Uncontrolled hypertension | Ulcer Digestive Uncontrolled | Glaucoma Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0041582
UMLS CUI [3,2]
C0012238
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0017601
UMLS CUI [4,2]
C0205318
patients with posterior subcapsular cataracts
Beschreibung

Posterior subcapsular cataract

Datentyp

boolean

Alias
UMLS CUI [1]
C0858617
patients with mental illness
Beschreibung

Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
patients with past histories or complications which make the investigator or other staff member deem them inappropriate for this study
Beschreibung

Medical History Study Subject Participation Status Inappropriate | Complications Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
pregnant or lactating females
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
grade 2 or worse neuropathy
Beschreibung

Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
any of the following laboratory abnormalities:
Beschreibung

Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
absolute neutrophil count (anc) < 1,000cells/ml platelet count < 75,000/ml serum creatinine > 2.5 mg/dl serum sgot/ast or sgpt/alt > 3.0 x upper limit of normal (uln)
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151905
prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. - patients who received radiation therapy within 14 days of the start of study drug
Beschreibung

Malignant Neoplasms | Exception Multiple Myeloma | Exception Disease Free of | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0026764
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [4]
C1522449
patients with scars from a recent viscus operation
Beschreibung

Scars Due to Operative Surgical Procedures Viscera

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0241158
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0042779
patients with history of a desquamating (blistering) rash while taking thalidomide
Beschreibung

Rash desquamating | Blistering rash | Thalidomide

Datentyp

boolean

Alias
UMLS CUI [1]
C0542171
UMLS CUI [2]
C0344311
UMLS CUI [3]
C0039736
patients with prior use of lenalidomide
Beschreibung

Lenalidomide

Datentyp

boolean

Alias
UMLS CUI [1]
C1144149
patients with known hiv positivity.
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of mm within 28 days of the start of lenalidomide therapy.
Beschreibung

Cytotoxic Chemotherapy | Immunomodulators | Investigational New Drugs | Intent Treatment Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C1527392
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C1283828
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0026764
patients with known history of hypersensitivity to dexamethasone.
Beschreibung

Dexamethasone allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571611
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00555100

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Prior Therapy Multiple Myeloma
Item
subjects with previously treated multiple myeloma
boolean
C1514463 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
Serum M Protein Level Measurable | M Protein In Urine Level 24 hour urine sample
Item
measurable levels of m-protein in serum >= 0.5 g/dl [5g/l]) or urine (>= 0.2 g excreted in a 24-hour collection sample)
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,4])
C0700271 (UMLS CUI [2,1])
C0042037 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0456209 (UMLS CUI [2,4])
ECOG performance status
Item
ecog performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods Adherence
Item
willing to follow pregnancy precautions
boolean
C0700589 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction | Deep Vein Thrombosis | Pulmonary Embolism
Item
patients with acute an myocardial infarction (mi) within the past 6 months, or patients with a history of deep vein thrombosis (dvt) or pulmonary embolism (pe) within the past 3 years
boolean
C0027051 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
Tuberculosis | Keratitis, Herpetic | Systemic mycosis | Communicable Diseases
Item
patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
boolean
C0041296 (UMLS CUI [1])
C0019357 (UMLS CUI [2])
C0553576 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
Diabetic - poor control | Uncontrolled hypertension | Ulcer Digestive Uncontrolled | Glaucoma Uncontrolled
Item
patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
boolean
C0421258 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0041582 (UMLS CUI [3,1])
C0012238 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0017601 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Posterior subcapsular cataract
Item
patients with posterior subcapsular cataracts
boolean
C0858617 (UMLS CUI [1])
Mental disorders
Item
patients with mental illness
boolean
C0004936 (UMLS CUI [1])
Medical History Study Subject Participation Status Inappropriate | Complications Study Subject Participation Status Inappropriate
Item
patients with past histories or complications which make the investigator or other staff member deem them inappropriate for this study
boolean
C0262926 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009566 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Neuropathy CTCAE Grades
Item
grade 2 or worse neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Laboratory test result abnormal
Item
any of the following laboratory abnormalities:
boolean
C0438215 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
absolute neutrophil count (anc) < 1,000cells/ml platelet count < 75,000/ml serum creatinine > 2.5 mg/dl serum sgot/ast or sgpt/alt > 3.0 x upper limit of normal (uln)
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
Malignant Neoplasms | Exception Multiple Myeloma | Exception Disease Free of | Therapeutic radiology procedure
Item
prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. - patients who received radiation therapy within 14 days of the start of study drug
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4])
Scars Due to Operative Surgical Procedures Viscera
Item
patients with scars from a recent viscus operation
boolean
C0241158 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0042779 (UMLS CUI [1,4])
Rash desquamating | Blistering rash | Thalidomide
Item
patients with history of a desquamating (blistering) rash while taking thalidomide
boolean
C0542171 (UMLS CUI [1])
C0344311 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
Lenalidomide
Item
patients with prior use of lenalidomide
boolean
C1144149 (UMLS CUI [1])
HIV Seropositivity
Item
patients with known hiv positivity.
boolean
C0019699 (UMLS CUI [1])
Cytotoxic Chemotherapy | Immunomodulators | Investigational New Drugs | Intent Treatment Multiple Myeloma
Item
patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of mm within 28 days of the start of lenalidomide therapy.
boolean
C0677881 (UMLS CUI [1])
C1527392 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1283828 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0026764 (UMLS CUI [4,3])
Dexamethasone allergy
Item
patients with known history of hypersensitivity to dexamethasone.
boolean
C0571611 (UMLS CUI [1])
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