ID
13953
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)
- 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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End of study LenaMain-Study
Trial End
- StudyEvent: ODM
Description
Survival Status
Description
Survival Status
Data type
integer
Alias
- UMLS CUI [1]
- C1148433
Description
Date of death
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Death certificate
Data type
boolean
Alias
- UMLS CUI [1]
- C0011066
Description
Autopsy
Data type
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
Cause of death
Data type
integer
Alias
- UMLS CUI [1]
- C0007465
Description
Cause of death
Data type
text
Alias
- UMLS CUI [1]
- C0007465
Description
Monthly control visit with response evaluation
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Cumulative dosage of trial substance during last cycle in mg
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C3174092
Description
Trial substance dosage
Data type
integer
Measurement units
- mg
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0178602
Description
Trial substance dosage
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0178602
Description
Dosage reduction
Data type
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0547047
Description
Response
Data type
integer
Alias
- UMLS CUI [1]
- C0521982
Description
External assessment of response
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0521982
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C0036524
Description
Adverse Events
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Parameter of multiple myeloma
Description
Cytogenetics
Data type
boolean
Alias
- UMLS CUI [1]
- C0010802
Description
Cytogenetics
Data type
text
Alias
- UMLS CUI [1]
- C0010802
Description
Cytogenetics
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0010802
Description
Contrast infiltration
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0009924
- UMLS CUI [1,2]
- C0332448
Description
Contrast examination date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0542435
Description
Extramedullary lesion
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1517060
- UMLS CUI [1,2]
- C0221198
Description
Osteolysis
Data type
integer
Alias
- UMLS CUI [1]
- C0221204
Description
Progressive disease reason
Data type
text
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C0566251
Description
Vital signs
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Body weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Ecog performance status
Data type
integer
Alias
- UMLS CUI [1]
- C1520224
Description
Laboratory:Protein electrophoresis
Description
Albumin
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0201838
Description
Total Protein
Data type
float
Measurement units
- mg/24h
Alias
- UMLS CUI [1]
- C0428541
Description
Total Serum Protein
Data type
float
Measurement units
- g/dl
Alias
- UMLS CUI [1]
- C0036836
Description
Beta-globulin
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0005157
Description
Gamma-Globulin
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0860681
Description
Please give the sum only, if stated in the lab sheet
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C1717622
Description
Serum immunofixation
Data type
integer
Alias
- UMLS CUI [1]
- C1271678
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Urine immunofixation
Data type
integer
Alias
- UMLS CUI [1]
- C1271641
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
IgA
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0202083
Description
IgD
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0577612
Description
IgG
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0202087
Description
IgM
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0202084
Description
FLC kappa
Data type
float
Measurement units
- mg/l
Alias
- UMLS CUI [1]
- C3274397
Description
Kappa
Data type
integer
Alias
- UMLS CUI [1]
- C0439099
Description
FLC lambda
Data type
float
Measurement units
- mg/l
Alias
- UMLS CUI [1]
- C3274399
Description
Lambda
Data type
integer
Alias
- UMLS CUI [1]
- C1706314
Description
Kappa/lambda quotient
Data type
integer
Alias
- UMLS CUI [1]
- C1168398
Description
Laboratory:Hematology
Description
Erythrocytes
Data type
float
Measurement units
- Mio/μl
Alias
- UMLS CUI [1]
- C0014772
Description
Hemoglobin
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0019046
Description
Hematocrit
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0518014
Description
MCV
Data type
float
Measurement units
- fl
Alias
- UMLS CUI [1]
- C1948043
Description
MCH
Data type
float
Measurement units
- pg
Alias
- UMLS CUI [1]
- C0369183
Description
MCHC
Data type
float
Measurement units
- g Hb/dL Ery
Alias
- UMLS CUI [1]
- C0474535
Description
Leukocytes
Data type
float
Measurement units
- 1000/μl
Alias
- UMLS CUI [1]
- C0023508
Description
Leukocytes
Data type
integer
Alias
- UMLS CUI [1]
- C1271681
Description
Platelets
Data type
float
Measurement units
- 1000/uL
Alias
- UMLS CUI [1]
- C0005821
Description
Neutrophils percentage
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2238207
Description
Neutrophils
Data type
float
Measurement units
- abs.
Alias
- UMLS CUI [1]
- C0948762
Description
Eosinophils percentage
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2228144
Description
Basophils percentage
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2237945
Description
Monocytes percentage
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2237144
Description
Lymphocytes percentage
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C2200256
Description
Neutrophils
Data type
float
Measurement units
- 1000/μl
Alias
- UMLS CUI [1]
- C0200633
Description
Laboratory:serum chemistry
Description
Sodium
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Description
Calcium
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0201925
Description
Glucose
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0202042
Description
Alkaline Phosphatase
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Bilirubin
Data type
float
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0005437
Description
AST
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
ALT
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
Gamma GT
Data type
float
Measurement units
- U/l
Alias
- UMLS CUI [1]
- C0202035
Description
LDH
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0202113
Description
Urea
Data type
float
Measurement units
- mg/dl
Alias
- UMLS CUI [1]
- C0523961
Description
CRP
Data type
float
Measurement units
- md/dl
Alias
- UMLS CUI [1]
- C0201657
Description
Creatinine, Serum
Data type
float
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Description
Creatinine Clearance
Data type
float
Measurement units
- mL/min
Alias
- UMLS CUI [1]
- C0373595
Description
Quality of life
Description
Hematotoxicity CTC
Description
Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest hemoglobin value)
Data type
integer
Alias
- UMLS CUI [1,1]
- C0019046
- UMLS CUI [1,2]
- C1516728
Description
Date of lowest hemoglobin value
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518015
Description
Actions taken with study medication
Data type
integer
Alias
- UMLS CUI [1]
- C1704758
Description
Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest leukocytes value)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0023516
Description
Date of lowest leukocytes value
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0023508
Description
Actions taken with study medication
Data type
integer
Alias
- UMLS CUI [1]
- C1704758
Description
Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest platelets value)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0032181
Description
Date of lowest platelets value
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0032181
Description
Actions taken with study medication
Data type
integer
Alias
- UMLS CUI [1]
- C1704758
Description
Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest neutrophils value)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0948762
Description
Date of lowest neutrophils value
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0948762
Description
Actions taken with study medication
Data type
integer
Alias
- UMLS CUI [1]
- C1704758
Similar models
Trial End
- StudyEvent: ODM
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0547047 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
C0036524 (UMLS CUI [1,3])
C0010802 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,2])
C0542435 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,2])
C0023508 (UMLS CUI [1,2])
C0032181 (UMLS CUI [1,2])
C0948762 (UMLS CUI [1,2])