ID

44129

Descripción

Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT); ODM derived from: https://clinicaltrials.gov/show/NCT00642395

Link

https://clinicaltrials.gov/show/NCT00642395

Palabras clave

Versiones (2)
  1. 27/6/18 27/6/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00642395

Inglés

Eligibility Multiple Myeloma NCT00642395

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
at time of diagnosis
Descripción

Timepoint Diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0011900
de novo multiple myeloma patients under 65 or in first relapse, in whom screening for chromosome 13 deletion and beta2microglobulin assay have been performed.
Descripción

Multiple Myeloma de novo | Age | First Relapse | Screening Loss of Chromosome 13 | Beta-2-microglobulin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C1515568
UMLS CUI [2]
C0001779
UMLS CUI [3]
C4054953
UMLS CUI [4,1]
C0220908
UMLS CUI [4,2]
C1517957
UMLS CUI [5]
C0201910
salmon and durie stage: iii, ii, i with symptomatic bone lesion (radiological)
Descripción

Durie/Salmon Stage | Bone lesion Symptomatic Radiologic examination

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4528204
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0043299
patient's written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
no clinical signs of heart failure or coronary insufficiency with lvef>50%
Descripción

Sign or Symptom Heart failure Absent | Sign or Symptom Coronary insufficiency Absent | Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0542052
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0428772
no hepatic in insufficiency: bilirubin<35μmol/l and sgot, sgpt, alkaline phosphatase less than 2.5 n
Descripción

Hepatic Insufficiency Absent | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
no respiratory insufficiency: normal pulmonary function tests and dlco>50%
Descripción

Respiratory Insufficiency Absent | Lung function testing normal | Carbon Monoxide Diffusing Capability Test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035229
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0438186
UMLS CUI [3]
C1516251
no pre-existing renal impairment not related to the disease
Descripción

Renal Insufficiency Pre-existing Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0332197
no history of any other malignant disease with the exception of basal cell carcinoma and stage i cervical cancer
Descripción

Malignant Neoplasms Absent | Exception Basal cell carcinoma | Exception Cervix carcinoma TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0302592
UMLS CUI [3,3]
C3258246
negative hiv serology
Descripción

Serology negative HIV

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0019682
effective contraception when justified
Descripción

Contraceptive methods As Needed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1720688
at the time of transplantation
Descripción

Timepoint Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0040732
good performance status (who score≤2)
Descripción

WHO performance status scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
creatinine≤170μmol/l and no ineligibility criteria for intensification
Descripción

Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
stem cells harvest ≥ 5x10e6 cd34/kg for 2 asct
Descripción

Stem cells Harvest CD34 Quantity | Transplantation of autologous hematopoietic stem cell Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038250
UMLS CUI [1,2]
C1512335
UMLS CUI [1,3]
C0054953
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C1831743
UMLS CUI [2,2]
C1265611
absence of progressive disease before transplantation
Descripción

Progressive Disease Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
known refusal of the subject to participate to the study
Descripción

Study Subject Participation Status Refusal to Participate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1136454
female subject who is pregnant or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of allergy to any of the study medications, their analogues, or excipients in the various formulations
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Investigational New Drug Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0243071
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C0015237
main liver insufficiency
Descripción

Hepatic Insufficiency Main

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1306571
UMLS CUI [1,2]
C1542147
≥ grade 3 peripheral neuropathy on clinical examination within 14 days before enrollment
Descripción

Peripheral Neuropathy CTCAE Grades Clinical examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [1,3]
C1456356
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Similar models

Eligibility Multiple Myeloma NCT00642395

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Timepoint Diagnosis
Item
at time of diagnosis
boolean
C2348792 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Multiple Myeloma de novo | Age | First Relapse | Screening Loss of Chromosome 13 | Beta-2-microglobulin measurement
Item
de novo multiple myeloma patients under 65 or in first relapse, in whom screening for chromosome 13 deletion and beta2microglobulin assay have been performed.
boolean
C0026764 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C4054953 (UMLS CUI [3])
C0220908 (UMLS CUI [4,1])
C1517957 (UMLS CUI [4,2])
C0201910 (UMLS CUI [5])
Durie/Salmon Stage | Bone lesion Symptomatic Radiologic examination
Item
salmon and durie stage: iii, ii, i with symptomatic bone lesion (radiological)
boolean
C4528204 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
Informed Consent
Item
patient's written informed consent
boolean
C0021430 (UMLS CUI [1])
Sign or Symptom Heart failure Absent | Sign or Symptom Coronary insufficiency Absent | Left ventricular ejection fraction
Item
no clinical signs of heart failure or coronary insufficiency with lvef>50%
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3540840 (UMLS CUI [2,1])
C0542052 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0428772 (UMLS CUI [3])
Hepatic Insufficiency Absent | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
no hepatic in insufficiency: bilirubin<35μmol/l and sgot, sgpt, alkaline phosphatase less than 2.5 n
boolean
C1306571 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Respiratory Insufficiency Absent | Lung function testing normal | Carbon Monoxide Diffusing Capability Test
Item
no respiratory insufficiency: normal pulmonary function tests and dlco>50%
boolean
C0035229 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0438186 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
Renal Insufficiency Pre-existing Absent
Item
no pre-existing renal impairment not related to the disease
boolean
C1565489 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Malignant Neoplasms Absent | Exception Basal cell carcinoma | Exception Cervix carcinoma TNM clinical staging
Item
no history of any other malignant disease with the exception of basal cell carcinoma and stage i cervical cancer
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0302592 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
Serology negative HIV
Item
negative hiv serology
boolean
C0919674 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
Contraceptive methods As Needed
Item
effective contraception when justified
boolean
C0700589 (UMLS CUI [1,1])
C1720688 (UMLS CUI [1,2])
Timepoint Transplantation
Item
at the time of transplantation
boolean
C2348792 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
WHO performance status scale
Item
good performance status (who score≤2)
boolean
C1298650 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine≤170μmol/l and no ineligibility criteria for intensification
boolean
C0201976 (UMLS CUI [1])
Stem cells Harvest CD34 Quantity | Transplantation of autologous hematopoietic stem cell Quantity
Item
stem cells harvest ≥ 5x10e6 cd34/kg for 2 asct
boolean
C0038250 (UMLS CUI [1,1])
C1512335 (UMLS CUI [1,2])
C0054953 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1831743 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Progressive Disease Absent
Item
absence of progressive disease before transplantation
boolean
C1335499 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status Refusal to Participate
Item
known refusal of the subject to participate to the study
boolean
C2348568 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
female subject who is pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Investigational New Drug Excipient
Item
history of allergy to any of the study medications, their analogues, or excipients in the various formulations
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0243071 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
Hepatic Insufficiency Main
Item
main liver insufficiency
boolean
C1306571 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Peripheral Neuropathy CTCAE Grades Clinical examination
Item
≥ grade 3 peripheral neuropathy on clinical examination within 14 days before enrollment
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
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