ID

21886

Beskrivning

VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates; ODM derived from: https://clinicaltrials.gov/show/NCT00320476

Länk

https://clinicaltrials.gov/show/NCT00320476

Nyckelord

Versioner (1)
  1. 2017-05-06 2017-05-06 -
Uppladdad den

6 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00320476

Engelsk

Eligibility Multiple Myeloma NCT00320476

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed patients with overt multiple myeloma who are not candidates for hdt/sct because of old age (> 65) or presence of comorbid conditions likely to have a negative impact on tolerability of hdt/sct. sponsors review this conditions and approval is required.
Beskrivning

Multiple Myeloma | Therapeutic procedure High dose Absent | Hemopoietic stem cell transplant Absent | Age | Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0444956
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0472699
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0009488
presence of measurable disease : serum m-protein > 1g/dl or urine m- protein > 400mg/day
Beskrivning

Measurable Disease | M Protein Serum | M Protein Urine

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0700271
UMLS CUI [2,2]
C0229671
UMLS CUI [3,1]
C0700271
UMLS CUI [3,2]
C0042036
performance status £ ecog 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
expected survival ³ 6 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
pretreatment clinical laboratory values meeting the following criteria within 14 days before enrollment platelet ≥ 100 x 109/l hemoglobin ≥ 8 g/dl (≥ 4.96 mol/l) prior rbc transfusion or recombinant human erythropoietin use is allowed) absolute neutrophil count (anc) ≥ 1.0 x 109/l aspartate aminotransferase (ast) ≤ 2.5 times the upper limit of normal alanine aminotransferase (alt) ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤
Beskrivning

Laboratory Results Pretreatment | Platelet Count measurement | Hemoglobin measurement | Red Blood Cell Transfusion | Recombinant Erythropoietin | Absolute neutrophil count | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C3539075
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0086252
UMLS CUI [5]
C0376541
UMLS CUI [6]
C0948762
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
UMLS CUI [9]
C1278039
UMLS CUI [10]
C0201976
3mg/dl corrected serum calcium <14 mg/dl (<3.5 mmol/l)
Beskrivning

Corrected serum calcium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0455288
subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Beskrivning

Informed Consent | Informed Consent Patient Representatives

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
smoldering or indolent myeloma
Beskrivning

Smoldering myeloma | Indolent Myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C1531608
UMLS CUI [2]
C1334169
history of allergic reaction attributable to compounds containing boron or mannitol
Beskrivning

Allergic Reaction Boron Compounds | Allergic Reaction Mannitol Compound

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0006031
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0024730
UMLS CUI [2,3]
C1706082
known hypersensitivity to thalidomide or dexamethasone
Beskrivning

Hypersensitivity Thalidomide | Dexamethasone allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
UMLS CUI [2]
C0571611
peripheral neuropathy or neuropathic pain grade 2 or higher as defined by nci ctcae version 3
Beskrivning

Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0458960
UMLS CUI [2,2]
C1516728
uncontrolled or severe cardiovascular disease, including mi within 6 months of enrolment, new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : severe conduction disorder : hypotension (sitting systolic bp ≤ 100 mmhg and/or sitting diastolic bp ≤ 60 mmhg
Beskrivning

Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis | Cardiac ejection fraction | Conduction disorder of the heart Severe | Hypotension | Sitting systolic blood pressure | Sitting diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0421196
UMLS CUI [6]
C0265122
UMLS CUI [7]
C0268407
UMLS CUI [8]
C0232174
UMLS CUI [9,1]
C0264886
UMLS CUI [9,2]
C0205082
UMLS CUI [10]
C0020649
UMLS CUI [11]
C1319893
UMLS CUI [12]
C1319894
sepsis
Beskrivning

Sepsis

Datatyp

boolean

Alias
UMLS CUI [1]
C0243026
pregnancy or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
uncontrolled diabetes mellitus
Beskrivning

Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
recurrent dvt or pulmonary embolism
Beskrivning

Recurrent deep vein thrombosis | Pulmonary Embolism

Datatyp

boolean

Alias
UMLS CUI [1]
C1735901
UMLS CUI [2]
C0034065
active ulcers detected by gastroscopy
Beskrivning

Ulcer Endoscopy of stomach

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0041582
UMLS CUI [1,2]
C0017195
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Beskrivning

Illness Serious Interferes with Study Subject Participation Status | Mental disorder Serious Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C2348568
receipt of extensive radiation therapy within 4 weeks
Beskrivning

Extensive Radiation

Datatyp

boolean

Alias
UMLS CUI [1]
C1517030
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Similar models

Eligibility Multiple Myeloma NCT00320476

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma | Therapeutic procedure High dose Absent | Hemopoietic stem cell transplant Absent | Age | Comorbidity
Item
newly diagnosed patients with overt multiple myeloma who are not candidates for hdt/sct because of old age (> 65) or presence of comorbid conditions likely to have a negative impact on tolerability of hdt/sct. sponsors review this conditions and approval is required.
boolean
C0026764 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0472699 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
Measurable Disease | M Protein Serum | M Protein Urine
Item
presence of measurable disease : serum m-protein > 1g/dl or urine m- protein > 400mg/day
boolean
C1513041 (UMLS CUI [1])
C0700271 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
C0700271 (UMLS CUI [3,1])
C0042036 (UMLS CUI [3,2])
ECOG performance status
Item
performance status £ ecog 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
expected survival ³ 6 months
boolean
C0023671 (UMLS CUI [1])
Laboratory Results Pretreatment | Platelet Count measurement | Hemoglobin measurement | Red Blood Cell Transfusion | Recombinant Erythropoietin | Absolute neutrophil count | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
pretreatment clinical laboratory values meeting the following criteria within 14 days before enrollment platelet ≥ 100 x 109/l hemoglobin ≥ 8 g/dl (≥ 4.96 mol/l) prior rbc transfusion or recombinant human erythropoietin use is allowed) absolute neutrophil count (anc) ≥ 1.0 x 109/l aspartate aminotransferase (ast) ≤ 2.5 times the upper limit of normal alanine aminotransferase (alt) ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤
boolean
C1254595 (UMLS CUI [1,1])
C3539075 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0086252 (UMLS CUI [4])
C0376541 (UMLS CUI [5])
C0948762 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201976 (UMLS CUI [10])
Corrected serum calcium measurement
Item
3mg/dl corrected serum calcium <14 mg/dl (<3.5 mmol/l)
boolean
C0455288 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representatives
Item
subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Smoldering myeloma | Indolent Myeloma
Item
smoldering or indolent myeloma
boolean
C1531608 (UMLS CUI [1])
C1334169 (UMLS CUI [2])
Allergic Reaction Boron Compounds | Allergic Reaction Mannitol Compound
Item
history of allergic reaction attributable to compounds containing boron or mannitol
boolean
C1527304 (UMLS CUI [1,1])
C0006031 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
Hypersensitivity Thalidomide | Dexamethasone allergy
Item
known hypersensitivity to thalidomide or dexamethasone
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0571611 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades | Peripheral neuropathic pain CTCAE Grades
Item
peripheral neuropathy or neuropathic pain grade 2 or higher as defined by nci ctcae version 3
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0458960 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Severe | Myocardial Infarction | Heart failure New York Heart Association Classification | Angina control - poor | Disorder of pericardium | Cardiac amyloidosis | Cardiac ejection fraction | Conduction disorder of the heart Severe | Hypotension | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
uncontrolled or severe cardiovascular disease, including mi within 6 months of enrolment, new york heart association (nyha) class iii or iv heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : severe conduction disorder : hypotension (sitting systolic bp ≤ 100 mmhg and/or sitting diastolic bp ≤ 60 mmhg
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0421196 (UMLS CUI [5])
C0265122 (UMLS CUI [6])
C0268407 (UMLS CUI [7])
C0232174 (UMLS CUI [8])
C0264886 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0020649 (UMLS CUI [10])
C1319893 (UMLS CUI [11])
C1319894 (UMLS CUI [12])
Sepsis
Item
sepsis
boolean
C0243026 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetic - poor control
Item
uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Recurrent deep vein thrombosis | Pulmonary Embolism
Item
recurrent dvt or pulmonary embolism
boolean
C1735901 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
Ulcer Endoscopy of stomach
Item
active ulcers detected by gastroscopy
boolean
C0041582 (UMLS CUI [1,1])
C0017195 (UMLS CUI [1,2])
Illness Serious Interferes with Study Subject Participation Status | Mental disorder Serious Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Extensive Radiation
Item
receipt of extensive radiation therapy within 4 weeks
boolean
C1517030 (UMLS CUI [1])
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