ID

13908

Beschreibung

A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Stichworte

  1. 16.03.16 16.03.16 -
Hochgeladen am

16. März 2016

DOI

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Baseline visit LenaMain-Study

Baseline Visit

  1. StudyEvent: ODM
    1. Baseline Visit
Inclusion of Patient
Beschreibung

Inclusion of Patient

Date of baseline visit
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Date of informed consent
Beschreibung

Date of informed consent

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Screening Date
Beschreibung

Screening Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710032
Date of Inclusion
Beschreibung

Inclusion date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1512693
Patient Birth Date
Beschreibung

Birth Date

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Patient age
Beschreibung

Age

Datentyp

integer

Alias
UMLS CUI [1]
C0001779
Remission status at baseline
Beschreibung

Remission status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0449438
ISS Score
Beschreibung

ISS Score

Datentyp

integer

Alias
UMLS CUI [1]
C2346508
Randomization
Beschreibung

Randomization

Datentyp

integer

Alias
UMLS CUI [1]
C0034656
Inclusion criteria
Beschreibung

Inclusion criteria

Informed consent obtained according to ICH/EU/GCP
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Age at enrollment
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Patient is willing and able to comply to study protocol
Beschreibung

Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
Patients with multiple myeloma, who received high-dose therapy and autologous stem cell therapy as initial therapy within the last 90-120 days and didn´t show any disease progression. Patients may have received a second high-dose therapy if not at least VGPR has been achieved or patients who received an intermediate dose of Melphalan due to age greater than 65 years.
Beschreibung

Multiple Myeloma

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
Patients may have received 6 cycles of Induction therapy (E. G. Idarubicine, Dexamethasone) and up to 2 cycles of a mobilization chemotherapy (E. G. Cyclophosphamide). Induction therapy with Bortezomib or Thalidomide is allowed as well as an accompanying Radiotherapy. The use of Lenalidomide as a single agent or Combination therapy is not allowed.
Beschreibung

Induction therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C3179010
Measurable paraprotein in serum (> 0.5 g / dL) or in urine (> 0.2 g / 24h) or measurable free Light chains (FLC) in serum (> 50 mg / l) with an abnormal FLC part must be documented at the time of diagnosis
Beschreibung

Paraprotein or measurable free Light chains (FLC) in serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030490
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0806492
ECOG performance status ≤2 at the time of enrollment
Beschreibung

Ecog performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Laboratory values within the following Limits: ANC ≥ 1,000 / uL, Platelets ≥ 100,000 / uL, total Bilirubin ≤ 2.5 mg / dL, AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
Beschreibung

Laboratory values

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0042295
Patient must be willing and able to use safe contraceptive measures.
Beschreibung

Contraceptive measures

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Women of childbearing potential must agree to the concurrent use of two medically approved, secure contraceptive methods or continuous abstinence from heterosexual intercourse. Men must consent to use condoms during the study until at least 28 days after conclusion of study, even after having a successful vasectomy, if their partner is of childbearing potential.
Beschreibung

Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Patients should not have suffered an active malignancy during the last 5 years with the exception of a currently treated Basalioma, a squamous cell carcinoma of the skin or a carcinoma "in situ" of the cervix or breast
Beschreibung

Malignancies

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
Exclusion criteria
Beschreibung

Exclusion criteria

Patient is unable to understand and sign informed consent due to any medical condition, change in laboratory parameter or mental illness
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Pregnancy or breastfeeding mothers
Beschreibung

Pregnancy or breastfeeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
All blood chemistry changes that would place an unacceptable risk to the patient in case of study participation or that could influence study evaluation
Beschreibung

Unacceptable risk or influence to study evaluation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1883420
UMLS CUI [1,2]
C0035647
UMLS CUI [2,1]
C1299715
UMLS CUI [2,2]
C0600366
Known hypersensitivity to thalidomide or lenalidomide
Beschreibung

Hypersensitivity thalidomide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
Any unexpected skin reaction with a CTC-grade equal to or higher than 3 (i.e: desquamating rash) during application of thalidomid or similar agents
Beschreibung

Adverse event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0221743
Prior use of lenalidomide
Beschreibung

Lenalidomide

Datentyp

boolean

Alias
UMLS CUI [1]
C1144149
Active infection with HIV or Hepatitis A,B or C
Beschreibung

Communicable disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
Parameter of multiple myeloma at enrollment
Beschreibung

Parameter of multiple myeloma at enrollment

ISS Stage
Beschreibung

ISS Stage

Datentyp

integer

Alias
UMLS CUI [1]
C2346508
Cytogenetic examination done?
Beschreibung

Cytogenetics

Datentyp

boolean

Alias
UMLS CUI [1]
C0010802
Cytogenetics:please specify
Beschreibung

Cytogenetics

Datentyp

text

Alias
UMLS CUI [1]
C0010802
Cytogenetics date
Beschreibung

Cytogenetics

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0010802
beta2-Microglobulin
Beschreibung

beta2-Microglobulin

Datentyp

integer

Maßeinheiten
  • mg/l
Alias
UMLS CUI [1]
C0005149
mg/l
Contrast infiltration
Beschreibung

Contrast infiltration

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0332448
%
Extramedullary lesion
Beschreibung

Extramedullary lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517060
UMLS CUI [1,2]
C0221198
Lytic lesion of bones
Beschreibung

Osteolysis

Datentyp

integer

Alias
UMLS CUI [1]
C0221204
Paraprotein
Beschreibung

Paraprotein

Datentyp

float

Maßeinheiten
  • g/dl
Alias
UMLS CUI [1]
C0030490
g/dl
Vital signs
Beschreibung

Vital signs

Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Blood pressure, diastolic
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Height
Beschreibung

Body Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Ecog performance status
Beschreibung

Ecog performance status

Datentyp

integer

Alias
UMLS CUI [1]
C1520224
Comorbidities
Beschreibung

Comorbidities

Consecutive number
Beschreibung

Number

Datentyp

integer

Alias
UMLS CUI [1]
C0750480
Comorbidity:please specify
Beschreibung

Comorbidity

Datentyp

text

Alias
UMLS CUI [1]
C0009488
Initial Diagnosis
Beschreibung

Initial Diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
Is the comorbidity persistent?
Beschreibung

Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C0549178
Does the comorbidity require treatment
Beschreibung

Treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
Laboratory:Protein electrophoresis
Beschreibung

Laboratory:Protein electrophoresis

Albumin
Beschreibung

Albumin

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C0201838
g/dL
Total Protein in 24h urine
Beschreibung

Total Protein

Datentyp

float

Maßeinheiten
  • mg/24h
Alias
UMLS CUI [1]
C0428541
mg/24h
Total Serum Protein
Beschreibung

Total Serum Protein

Datentyp

float

Maßeinheiten
  • g/dl
Alias
UMLS CUI [1]
C0036836
g/dl
Beta-globulin measurement
Beschreibung

Beta-globulin

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C0005157
g/dL
Gamma-Globulin measurement
Beschreibung

Gamma-Globulin

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C0860681
g/dL
Beta and gamma globulin total
Beschreibung

Please give the sum only, if stated in the lab sheet

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C1717622
g/dL
Serum immunofixation
Beschreibung

Serum immunofixation

Datentyp

integer

Alias
UMLS CUI [1]
C1271678
Comment on serum immunofixation
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Urine immunofixation
Beschreibung

Urine immunofixation

Datentyp

integer

Alias
UMLS CUI [1]
C1271641
Comment on urine immunofixation
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
IgA measurement
Beschreibung

IgA

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1]
C0202083
mg/dl
IgD measurement
Beschreibung

IgD

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1]
C0577612
mg/dl
IgG measurement
Beschreibung

IgG

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1]
C0202087
mg/dl
Immunoglobulin M measurement
Beschreibung

IgM

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1]
C0202084
mg/dl
FLC kappa measurement
Beschreibung

FLC kappa

Datentyp

float

Maßeinheiten
  • mg/l
Alias
UMLS CUI [1]
C3274397
mg/l
Kappa
Beschreibung

Kappa

Datentyp

integer

Alias
UMLS CUI [1]
C0439099
FLC lambda measurement
Beschreibung

FLC lambda

Datentyp

float

Maßeinheiten
  • mg/l
Alias
UMLS CUI [1]
C3274399
mg/l
Lambda
Beschreibung

Lambda

Datentyp

integer

Alias
UMLS CUI [1]
C1706314
Kappa/lambda quotient
Beschreibung

Kappa/lambda quotient

Datentyp

integer

Alias
UMLS CUI [1]
C1168398
Laboratory:Hematology
Beschreibung

Laboratory:Hematology

Erythrocytes
Beschreibung

Erythrocytes

Datentyp

float

Maßeinheiten
  • Mio/μl
Alias
UMLS CUI [1]
C0014772
Mio/μl
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

float

Maßeinheiten
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Hematocrit
Beschreibung

Hematocrit

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0518014
%
Mean Corpuscular Volume
Beschreibung

MCV

Datentyp

float

Maßeinheiten
  • fl
Alias
UMLS CUI [1]
C1948043
fl
MCH
Beschreibung

MCH

Datentyp

float

Maßeinheiten
  • pg
Alias
UMLS CUI [1]
C0369183
pg
Mean corpuscular hemoglobin concentration
Beschreibung

MCHC

Datentyp

float

Maßeinheiten
  • g Hb/dL Ery
Alias
UMLS CUI [1]
C0474535
g Hb/dL Ery
Leukocytes
Beschreibung

Leukocytes

Datentyp

float

Maßeinheiten
  • 1000/μl
Alias
UMLS CUI [1]
C0023508
1000/μl
Leukocytes (total)
Beschreibung

Leukocytes

Datentyp

integer

Alias
UMLS CUI [1]
C1271681
Platelet count
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
UMLS CUI [1]
C0005821
1000/uL
Neutrophils percentage
Beschreibung

Neutrophils percentage

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C2238207
%
Neutrophils
Beschreibung

Neutrophils

Datentyp

float

Maßeinheiten
  • abs.
Alias
UMLS CUI [1]
C0948762
abs.
Eosinophils percentage
Beschreibung

Eosinophils percentage

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C2228144
%
Basophils percentage
Beschreibung

Basophils percentage

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C2237945
%
Monocytes percentage
Beschreibung

Monocytes percentage

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C2237144
%
Lymphocytes percentage
Beschreibung

Lymphocytes percentage

Datentyp

float

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C2200256
%
Neutrophils
Beschreibung

Neutrophils

Datentyp

float

Maßeinheiten
  • 1000/μl
Alias
UMLS CUI [1]
C0200633
1000/μl
Laboratory:serum chemistry
Beschreibung

Laboratory:serum chemistry

Sodium
Beschreibung

Sodium

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Beschreibung

Potassium

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Calcium
Beschreibung

Calcium

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0201925
mmol/l
Glucose
Beschreibung

Glucose

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1]
C0202042
mg/dl
Alkaline Phosphatase
Beschreibung

Alkaline Phosphatase

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Bilirubin
Beschreibung

Bilirubin

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
AST (SGOT)
Beschreibung

AST

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
ALT
Beschreibung

ALT

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
Gamma GT
Beschreibung

Gamma GT

Datentyp

float

Maßeinheiten
  • U/l
Alias
UMLS CUI [1]
C0202035
U/l
Lactate Dehydrogenase (LDH)
Beschreibung

LDH

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
Urea
Beschreibung

Urea

Datentyp

float

Maßeinheiten
  • mg/dl
Alias
UMLS CUI [1]
C0523961
mg/dl
CRP
Beschreibung

CRP

Datentyp

float

Maßeinheiten
  • md/dl
Alias
UMLS CUI [1]
C0201657
md/dl
Serum creatinine
Beschreibung

Creatinine, Serum

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Creatinine Clearance
Beschreibung

Creatinine Clearance

Datentyp

float

Maßeinheiten
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
Laboratory:pregnancy test
Beschreibung

Laboratory:pregnancy test

Is the subject of childbearing potential?
Beschreibung

Childbearing potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
Pregnancy test result
Beschreibung

Pregnancy test

Datentyp

integer

Alias
UMLS CUI [1]
C0032976
Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
Beschreibung

Menstruation

Datentyp

integer

Alias
UMLS CUI [1]
C0025344
Quality of life
Beschreibung

Quality of life

Total Score QoL
Beschreibung

Please answer questions 1-30 of the EORTC QIQ-C30 Quality of Life

Datentyp

float

Alias
UMLS CUI [1]
C3476431

Ähnliche Modelle

Baseline Visit

  1. StudyEvent: ODM
    1. Baseline Visit
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion of Patient
Date
Item
Date of baseline visit
date
C0011008 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Screening Date
Item
Screening Date
date
C0011008 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
Inclusion date
Item
Date of Inclusion
date
C0011008 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
Birth Date
Item
Patient Birth Date
date
C0421451 (UMLS CUI [1])
Age
Item
Patient age
integer
C0001779 (UMLS CUI [1])
Item
Remission status at baseline
integer
C0544452 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Remission status at baseline
CL Item
sCR (0)
CL Item
CR (1)
CL Item
vgPR (2)
CL Item
PR (3)
CL Item
SD (5)
CL Item
PD (6)
Item
ISS Score
integer
C2346508 (UMLS CUI [1])
Code List
ISS Score
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Randomization
integer
C0034656 (UMLS CUI [1])
Code List
Randomization
CL Item
Branch A (1)
CL Item
Branch B (2)
Item Group
Inclusion criteria
Informed consent
Item
Informed consent obtained according to ICH/EU/GCP
boolean
C0021430 (UMLS CUI [1])
Age
Item
Age at enrollment
boolean
C0001779 (UMLS CUI [1])
Compliance behavior
Item
Patient is willing and able to comply to study protocol
boolean
C1321605 (UMLS CUI [1])
Multiple Myeloma
Item
Patients with multiple myeloma, who received high-dose therapy and autologous stem cell therapy as initial therapy within the last 90-120 days and didn´t show any disease progression. Patients may have received a second high-dose therapy if not at least VGPR has been achieved or patients who received an intermediate dose of Melphalan due to age greater than 65 years.
boolean
C0026764 (UMLS CUI [1])
Induction therapy
Item
Patients may have received 6 cycles of Induction therapy (E. G. Idarubicine, Dexamethasone) and up to 2 cycles of a mobilization chemotherapy (E. G. Cyclophosphamide). Induction therapy with Bortezomib or Thalidomide is allowed as well as an accompanying Radiotherapy. The use of Lenalidomide as a single agent or Combination therapy is not allowed.
boolean
C3179010 (UMLS CUI [1])
Paraprotein or measurable free Light chains (FLC) in serum
Item
Measurable paraprotein in serum (> 0.5 g / dL) or in urine (> 0.2 g / 24h) or measurable free Light chains (FLC) in serum (> 50 mg / l) with an abnormal FLC part must be documented at the time of diagnosis
boolean
C0030490 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0806492 (UMLS CUI [1,4])
Ecog performance status
Item
ECOG performance status ≤2 at the time of enrollment
boolean
C1520224 (UMLS CUI [1])
Laboratory values
Item
Laboratory values within the following Limits: ANC ≥ 1,000 / uL, Platelets ≥ 100,000 / uL, total Bilirubin ≤ 2.5 mg / dL, AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
boolean
C0022877 (UMLS CUI [1,1])
C0042295 (UMLS CUI [1,2])
Contraceptive measures
Item
Patient must be willing and able to use safe contraceptive measures.
boolean
C0700589 (UMLS CUI [1])
Contraceptive methods
Item
Women of childbearing potential must agree to the concurrent use of two medically approved, secure contraceptive methods or continuous abstinence from heterosexual intercourse. Men must consent to use condoms during the study until at least 28 days after conclusion of study, even after having a successful vasectomy, if their partner is of childbearing potential.
boolean
C0700589 (UMLS CUI [1])
Malignancies
Item
Patients should not have suffered an active malignancy during the last 5 years with the exception of a currently treated Basalioma, a squamous cell carcinoma of the skin or a carcinoma "in situ" of the cervix or breast
boolean
C0006826 (UMLS CUI [1])
Item Group
Exclusion criteria
Informed consent
Item
Patient is unable to understand and sign informed consent due to any medical condition, change in laboratory parameter or mental illness
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Pregnancy or breastfeeding
Item
Pregnancy or breastfeeding mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Unacceptable risk or influence to study evaluation
Item
All blood chemistry changes that would place an unacceptable risk to the patient in case of study participation or that could influence study evaluation
boolean
C1883420 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C1299715 (UMLS CUI [2,1])
C0600366 (UMLS CUI [2,2])
Hypersensitivity thalidomide
Item
Known hypersensitivity to thalidomide or lenalidomide
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
Adverse event
Item
Any unexpected skin reaction with a CTC-grade equal to or higher than 3 (i.e: desquamating rash) during application of thalidomid or similar agents
boolean
C0877248 (UMLS CUI [1,1])
C0221743 (UMLS CUI [1,2])
Lenalidomide
Item
Prior use of lenalidomide
boolean
C1144149 (UMLS CUI [1])
Communicable disease
Item
Active infection with HIV or Hepatitis A,B or C
boolean
C0009450 (UMLS CUI [1])
Item Group
Parameter of multiple myeloma at enrollment
Item
ISS Stage
integer
C2346508 (UMLS CUI [1])
Code List
ISS Stage
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Cytogenetics
Item
Cytogenetic examination done?
boolean
C0010802 (UMLS CUI [1])
Cytogenetics
Item
Cytogenetics:please specify
text
C0010802 (UMLS CUI [1])
Cytogenetics
Item
Cytogenetics date
date
C0011008 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
beta2-Microglobulin
Item
beta2-Microglobulin
integer
C0005149 (UMLS CUI [1])
Contrast infiltration
Item
Contrast infiltration
integer
C0009924 (UMLS CUI [1,1])
C0332448 (UMLS CUI [1,2])
Extramedullary lesion
Item
Extramedullary lesion
boolean
C1517060 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
Lytic lesion of bones
integer
C0221204 (UMLS CUI [1])
Code List
Lytic lesion of bones
CL Item
None (1)
CL Item
Osteopenia (2)
CL Item
1-5 lytic lesions of bone (3)
CL Item
>6 lytic lesions of bone (4)
Paraprotein
Item
Paraprotein
float
C0030490 (UMLS CUI [1])
Item Group
Vital signs
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, systolic
integer
C0005823 (UMLS CUI [1])
Blood pressure
Item
Blood pressure, diastolic
integer
C0005823 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Item
Ecog performance status
integer
C1520224 (UMLS CUI [1])
Code List
Ecog performance status
CL Item
Score 0 (0)
CL Item
Score 1 (1)
CL Item
Score 2 (2)
CL Item
Score 3 (3)
CL Item
Score 4 (4)
CL Item
Score 5 (5)
Item Group
Comorbidities
Number
Item
Consecutive number
integer
C0750480 (UMLS CUI [1])
Comorbidity
Item
Comorbidity:please specify
text
C0009488 (UMLS CUI [1])
Initial Diagnosis
Item
Initial Diagnosis
date
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Ongoing
Item
Is the comorbidity persistent?
boolean
C0549178 (UMLS CUI [1])
Treatment
Item
Does the comorbidity require treatment
boolean
C0087111 (UMLS CUI [1])
Item Group
Laboratory:Protein electrophoresis
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total Protein
Item
Total Protein in 24h urine
float
C0428541 (UMLS CUI [1])
Total Serum Protein
Item
Total Serum Protein
float
C0036836 (UMLS CUI [1])
Beta-globulin
Item
Beta-globulin measurement
float
C0005157 (UMLS CUI [1])
Gamma-Globulin
Item
Gamma-Globulin measurement
float
C0860681 (UMLS CUI [1])
Beta and gamma globulin total
Item
Beta and gamma globulin total
float
C1717622 (UMLS CUI [1])
Item
Serum immunofixation
integer
C1271678 (UMLS CUI [1])
Code List
Serum immunofixation
CL Item
positive (1)
CL Item
negative (2)
Comment
Item
Comment on serum immunofixation
text
C0947611 (UMLS CUI [1])
Item
Urine immunofixation
integer
C1271641 (UMLS CUI [1])
Code List
Urine immunofixation
CL Item
positive (1)
CL Item
negative (2)
Comment
Item
Comment on urine immunofixation
text
C0947611 (UMLS CUI [1])
IgA
Item
IgA measurement
float
C0202083 (UMLS CUI [1])
IgD
Item
IgD measurement
float
C0577612 (UMLS CUI [1])
IgG
Item
IgG measurement
float
C0202087 (UMLS CUI [1])
IgM
Item
Immunoglobulin M measurement
float
C0202084 (UMLS CUI [1])
FLC kappa
Item
FLC kappa measurement
float
C3274397 (UMLS CUI [1])
Kappa
Item
Kappa
integer
C0439099 (UMLS CUI [1])
FLC lambda
Item
FLC lambda measurement
float
C3274399 (UMLS CUI [1])
Lambda
Item
Lambda
integer
C1706314 (UMLS CUI [1])
Kappa/lambda quotient
Item
Kappa/lambda quotient
integer
C1168398 (UMLS CUI [1])
Item Group
Laboratory:Hematology
Erythrocytes
Item
Erythrocytes
float
C0014772 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
MCV
Item
Mean Corpuscular Volume
float
C1948043 (UMLS CUI [1])
MCH
Item
MCH
float
C0369183 (UMLS CUI [1])
MCHC
Item
Mean corpuscular hemoglobin concentration
float
C0474535 (UMLS CUI [1])
Leukocytes
Item
Leukocytes
float
C0023508 (UMLS CUI [1])
Leukocytes
Item
Leukocytes (total)
integer
C1271681 (UMLS CUI [1])
Platelets
Item
Platelet count
float
C0005821 (UMLS CUI [1])
Neutrophils percentage
Item
Neutrophils percentage
float
C2238207 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Eosinophils percentage
Item
Eosinophils percentage
float
C2228144 (UMLS CUI [1])
Basophils percentage
Item
Basophils percentage
float
C2237945 (UMLS CUI [1])
Monocytes percentage
Item
Monocytes percentage
float
C2237144 (UMLS CUI [1])
Lymphocytes percentage
Item
Lymphocytes percentage
float
C2200256 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1])
Item Group
Laboratory:serum chemistry
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Bilirubin
Item
Bilirubin
float
C0005437 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
Gamma GT
Item
Gamma GT
float
C0202035 (UMLS CUI [1])
LDH
Item
Lactate Dehydrogenase (LDH)
float
C0202113 (UMLS CUI [1])
Urea
Item
Urea
float
C0523961 (UMLS CUI [1])
CRP
Item
CRP
float
C0201657 (UMLS CUI [1])
Creatinine, Serum
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Item Group
Laboratory:pregnancy test
Childbearing potential
Item
Is the subject of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
Pregnancy test result
integer
C0032976 (UMLS CUI [1])
Code List
Pregnancy test result
CL Item
positive (1)
CL Item
negative (2)
Item
Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
integer
C0025344 (UMLS CUI [1])
Code List
Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
CL Item
No menstruation (0)
CL Item
Yes (1)
CL Item
No (2)
Item Group
Quality of life
Quality of life score
Item
Total Score QoL
float
C3476431 (UMLS CUI [1])

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