ID

13911

Description

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

Keywords

Versions (2)
  1. 3/16/16 3/16/16 -
  2. 3/16/16 3/16/16 -
Uploaded on

March 16, 2016

DOI

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License

Creative Commons BY-NC 3.0
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First Consolidation Cycle 1.week LenaMain-Study

English

First Consolidation Cycle

1 forms  
Weekly control visit (large)
Description

Weekly control visit (large)

Date of visit
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Medication dosage of last cycle
Description

Cumulative dosage of trial substance during last cycle in mg

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Prior trial substance dosage
Description

Trial substance dosage

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
New trial substance dosage
Description

Trial substance dosage

Data type

integer

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
Please specify reason for dose reduction
Description

Dosage reduction

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0547047
Did any Adverse Events occur?
Description

Adverse Events

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Vital signs
Description

Vital signs

Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Blood pressure, systolic
Description

Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Blood pressure, diastolic
Description

Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Ecog performance status
Description

Ecog performance status

Data type

integer

Alias
UMLS CUI [1]
C1520224
Laboratory:Hematology
Description

Laboratory:Hematology

Erythrocytes
Description

Erythrocytes

Data type

float

Measurement units
  • Mio/μl
Alias
UMLS CUI [1]
C0014772
Mio/μl
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Hematocrit
Description

Hematocrit

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0518014
%
Mean Corpuscular Volume
Description

MCV

Data type

float

Measurement units
  • fl
Alias
UMLS CUI [1]
C1948043
fl
MCH
Description

MCH

Data type

float

Measurement units
  • pg
Alias
UMLS CUI [1]
C0369183
pg
Mean corpuscular hemoglobin concentration
Description

MCHC

Data type

float

Measurement units
  • g Hb/dL Ery
Alias
UMLS CUI [1]
C0474535
g Hb/dL Ery
Leukocytes
Description

Leukocytes

Data type

float

Measurement units
  • 1000/μl
Alias
UMLS CUI [1]
C0023508
1000/μl
Leukocytes (total)
Description

Leukocytes

Data type

integer

Alias
UMLS CUI [1]
C1271681
Platelet count
Description

Platelets

Data type

float

Measurement units
  • 1000/uL
Alias
UMLS CUI [1]
C0005821
1000/uL
Neutrophils percentage
Description

Neutrophils percentage

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2238207
%
Neutrophils
Description

Neutrophils

Data type

float

Measurement units
  • abs.
Alias
UMLS CUI [1]
C0948762
abs.
Eosinophils percentage
Description

Eosinophils percentage

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2228144
%
Basophils percentage
Description

Basophils percentage

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2237945
%
Monocytes percentage
Description

Monocytes percentage

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2237144
%
Lymphocytes percentage
Description

Lymphocytes percentage

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C2200256
%
Neutrophils
Description

Neutrophils

Data type

float

Measurement units
  • 1000/μl
Alias
UMLS CUI [1]
C0200633
1000/μl
Laboratory:serum chemistry
Description

Laboratory:serum chemistry

Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202194
mmol/l
Calcium
Description

Calcium

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0201925
mmol/l
Glucose
Description

Glucose

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0202042
mg/dl
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Bilirubin
Description

Bilirubin

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
AST (SGOT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
ALT
Description

ALT

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
Gamma GT
Description

Gamma GT

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1]
C0202035
U/l
Lactate Dehydrogenase (LDH)
Description

LDH

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
Urea
Description

Urea

Data type

float

Measurement units
  • mg/dl
Alias
UMLS CUI [1]
C0523961
mg/dl
CRP
Description

CRP

Data type

float

Measurement units
  • md/dl
Alias
UMLS CUI [1]
C0201657
md/dl
Serum creatinine
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Creatinine Clearance
Description

Creatinine Clearance

Data type

float

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
Laboratory:pregnancy test
Description

Laboratory:pregnancy test

Is the subject of childbearing potential?
Description

Childbearing potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
Pregnancy test result
Description

Pregnancy test

Data type

integer

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

Menstruation

Data type

integer

Alias
UMLS CUI [1]
C0025344
Quality of life
Description

Quality of life

Total Score QoL
Description

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

Data type

float

Alias
UMLS CUI [1]
C3476431
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Similar models

First Consolidation Cycle

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Weekly control visit (large)
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Medication dosage
Item
Medication dosage of last cycle
float
C3174092 (UMLS CUI [1])
Item
Prior trial substance dosage
integer
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Trial substance dosage
Code List
Prior trial substance dosage
CL Item
25 mg (1)
CL Item
15 mg (2)
CL Item
10 mg (3)
CL Item
5 mg (4)
CL Item
20 mg (5)
Item
New trial substance dosage
integer
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Trial substance dosage
Code List
New trial substance dosage
CL Item
25 mg (1)
CL Item
15 mg (2)
CL Item
10 mg (3)
CL Item
5 mg (4)
CL Item
20 mg (5)
Dosage reduction
Item
Please specify reason for dose reduction
text
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Adverse Events
Item
Did any Adverse Events occur?
boolean
C0877248 (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])
Ecog performance status
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
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])
Pregnancy test
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])
Menstruation
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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