ID

13925

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 (1)
  1. 3/17/16 3/17/16 -
Uploaded on

March 17, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Third Consolidation Cycle 3.week LenaMain-Study

English

Third Consolidation Cycle

1 forms  
3. Weekly control visit (large)
Description

3. Weekly control visit (large)

Date of visit
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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
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
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Similar models

Third Consolidation Cycle

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
3. Weekly control visit (large)
Date
Item
Date of visit
date
C0011008 (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
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])
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