ID

43842

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2016-03-15 2016-03-15 -
  2. 2021-09-20 2021-09-20 -
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20 september 2021

DOI

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Screening Visit LenaMain-Study

Engelsk

Screening visit

1 Formulär  
  1. StudyEvent: ODM
    1. Screening visit
Medical history
Beskrivning

Medical history

Date of screening visit
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1698960
Date of Informed Consent
Beskrivning

Informed Consent date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1]
C0079399
Date of initial diagnosis
Beskrivning

Date of initial diagnosis

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
Monoclonal gammopathy of undetermined significance (MGUS-Preliminary phase)
Beskrivning

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Datatyp

boolean

Alias
UMLS CUI [1]
C0026470
Date of initial diagnosis: MGUS
Beskrivning

Date of initial diagnosis: MGUS

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0026470
Multiple Myeloma,not eligible for treatment
Beskrivning

Multiple Myeloma,not eligible for treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0013893
UMLS CUI [1,3]
C0039798
Date of initial diagnosis: MM,not eligible for treatment
Beskrivning

Date of initial diagnosis

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0026764
Multiple myeloma, eligible for treatment
Beskrivning

Multiple myeloma, eligible for treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0013893
UMLS CUI [1,3]
C0039798
Date of initial diagnosis:MM,eligible for treatment
Beskrivning

Date of initial diagnosis

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0026764
Previous treatment:please specify
Beskrivning

Previous treatment

Datatyp

text

Alias
UMLS CUI [1]
C0087111
Number of induction cycles
Beskrivning

Induction cycle

Datatyp

integer

Alias
UMLS CUI [1]
C0857127
Response to induction
Beskrivning

Response to induction

Datatyp

integer

Alias
UMLS CUI [1]
C0521982
Date of response to induction
Beskrivning

Date of response

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0871261
Number of mobilization cycles
Beskrivning

Number of mobilization cycles

Datatyp

integer

Alias
UMLS CUI [1]
C0524864
Response to mobilization
Beskrivning

Response to mobilization

Datatyp

text

Alias
UMLS CUI [1,1]
C0524864
UMLS CUI [1,2]
C0521982
Date of response:mobilization
Beskrivning

Date of response:mobilization

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0524864
UMLS CUI [1,3]
C0521982
Radiation therapy:please specify
Beskrivning

Radiation therapy

Datatyp

text

Alias
UMLS CUI [1]
C1522449
Date of first stem cell transplant
Beskrivning

Date of first transplant

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0919688
Conditioning
Beskrivning

Conditioning

Datatyp

integer

Alias
UMLS CUI [1]
C0376450
If other conditioning,please specify
Beskrivning

Conditioning

Datatyp

text

Alias
UMLS CUI [1]
C0376450
Response after first transplant
Beskrivning

Response

Datatyp

integer

Alias
UMLS CUI [1]
C0521982
Date of Evaluation
Beskrivning

Date of Evaluation

Datatyp

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Date of second transplant
Beskrivning

Date of second transplant

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0919688
Conditioning
Beskrivning

Conditioning

Datatyp

integer

Alias
UMLS CUI [1]
C0376450
If other conditioning,please specify
Beskrivning

Conditioning

Datatyp

text

Alias
UMLS CUI [1]
C0376450
Response after second transplant
Beskrivning

Response

Datatyp

integer

Alias
UMLS CUI [1]
C0521982
Date of evaluation
Beskrivning

Date of evaluation

Datatyp

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Initial diagnosis: Multiple myeloma
Beskrivning

Initial diagnosis: Multiple myeloma

Subtype
Beskrivning

Subtype

Datatyp

integer

Alias
UMLS CUI [1]
C0449560
Light chain
Beskrivning

Light chain

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0021038
Salmon-Durie Stage
Beskrivning

Salmon-Durie Stage

Datatyp

integer

Alias
UMLS CUI [1]
C3846373
Salmon-Durie Stage codicil
Beskrivning

Salmon-Durie Stage

Datatyp

integer

Alias
UMLS CUI [1]
C3846373
ISS Stage
Beskrivning

ISS Stage

Datatyp

integer

Alias
UMLS CUI [1]
C2346508
beta2-Microglobulin
Beskrivning

beta2-Microglobulin

Datatyp

integer

Måttenheter
  • mg/l
Alias
UMLS CUI [1]
C0005149
mg/l
Albumin
Beskrivning

Albumin

Datatyp

float

Måttenheter
  • g/dL
Alias
UMLS CUI [1]
C0201838
g/dL
Cytogenetic examination done?
Beskrivning

Cytogenetics

Datatyp

boolean

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

Cytogenetics

Datatyp

text

Alias
UMLS CUI [1]
C0010802
Cytogenetic examination date
Beskrivning

Cytogenetic examination date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0010802
Contrast infiltration
Beskrivning

Contrast infiltration

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C0332448
%
Contrast examination date
Beskrivning

Contrast examination date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0542435
Extramedullary lesion
Beskrivning

Extramedullary lesion

Datatyp

boolean

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

Osteolysis

Datatyp

integer

Alias
UMLS CUI [1]
C0221204
Complications:please specify
Beskrivning

Complications

Datatyp

text

Alias
UMLS CUI [1]
C0009566
Vital signs
Beskrivning

Vital signs

Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Beskrivning

Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Diastolic blood pressure
Beskrivning

Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Body weight
Beskrivning

Body weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Height
Beskrivning

Body Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
ECOG Performance status
Beskrivning

ECOG

Datatyp

integer

Alias
UMLS CUI [1]
C1520224
ECG normal?
Beskrivning

ECG findings

Datatyp

boolean

Alias
UMLS CUI [1]
C0438154
Please specify any pathologic ECG findings
Beskrivning

ECG findings

Datatyp

text

Alias
UMLS CUI [1]
C0438154
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Similar models

Screening visit

1 Formulär
  1. StudyEvent: ODM
    1. Screening visit
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Medical history
Date
Item
Date of screening visit
date
C0011008 (UMLS CUI [1,1])
C1698960 (UMLS CUI [1,2])
Informed Consent date
Item
Date of Informed Consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Date of initial diagnosis
Item
Date of initial diagnosis
date
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Item
Monoclonal gammopathy of undetermined significance (MGUS-Preliminary phase)
boolean
C0026470 (UMLS CUI [1])
Date of initial diagnosis: MGUS
Item
Date of initial diagnosis: MGUS
date
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0026470 (UMLS CUI [1,3])
Multiple Myeloma,not eligible for treatment
Item
Multiple Myeloma,not eligible for treatment
boolean
C0026764 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
C0039798 (UMLS CUI [1,3])
Date of initial diagnosis
Item
Date of initial diagnosis: MM,not eligible for treatment
date
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Multiple myeloma, eligible for treatment
Item
Multiple myeloma, eligible for treatment
boolean
C0026764 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
C0039798 (UMLS CUI [1,3])
Date of initial diagnosis
Item
Date of initial diagnosis:MM,eligible for treatment
date
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
Previous treatment
Item
Previous treatment:please specify
text
C0087111 (UMLS CUI [1])
Item
Number of induction cycles
integer
C0857127 (UMLS CUI [1])
Induction cycle
Code List
Number of induction cycles
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item
Response to induction
integer
C0521982 (UMLS CUI [1])
Response to induction
Code List
Response to induction
CL Item
sCR (0)
CL Item
CR (1)
CL Item
vgPR (2)
CL Item
PR (3)
CL Item
SD (5)
CL Item
PD (6)
Date of response
Item
Date of response to induction
date
C0011008 (UMLS CUI [1,1])
C0871261 (UMLS CUI [1,2])
Item
Number of mobilization cycles
integer
C0524864 (UMLS CUI [1])
Number of mobilization cycles
Code List
Number of mobilization cycles
CL Item
1 (1)
CL Item
2 (2)
Item
Response to mobilization
text
C0524864 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Response to mobilization
Code List
Response to mobilization
CL Item
sCR (0)
CL Item
CR (1)
CL Item
vgPR (2)
CL Item
PR (3)
CL Item
SD (5)
CL Item
PD (6)
Date of response:mobilization
Item
Date of response:mobilization
date
C0011008 (UMLS CUI [1,1])
C0524864 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,3])
Radiation therapy
Item
Radiation therapy:please specify
text
C1522449 (UMLS CUI [1])
Date of first transplant
Item
Date of first stem cell transplant
date
C0011008 (UMLS CUI [1,1])
C0919688 (UMLS CUI [1,2])
Item
Conditioning
integer
C0376450 (UMLS CUI [1])
Conditioning
Code List
Conditioning
CL Item
M100 (1)
CL Item
M140 (2)
CL Item
M200 (3)
CL Item
other (4)
Conditioning
Item
If other conditioning,please specify
text
C0376450 (UMLS CUI [1])
Item
Response after first transplant
integer
C0521982 (UMLS CUI [1])
Response
Code List
Response after first transplant
CL Item
sCR (0)
CL Item
CR (1)
CL Item
vgPR (2)
CL Item
PR (3)
CL Item
SD (5)
CL Item
PD (6)
Date of Evaluation
Item
Date of Evaluation
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of second transplant
Item
Date of second transplant
date
C0011008 (UMLS CUI [1,1])
C0919688 (UMLS CUI [1,2])
Item
Conditioning
integer
C0376450 (UMLS CUI [1])
Conditioning
Code List
Conditioning
CL Item
M100 (1)
CL Item
M140 (2)
CL Item
M200 (3)
CL Item
other (4)
Conditioning
Item
If other conditioning,please specify
text
C0376450 (UMLS CUI [1])
Item
Response after second transplant
integer
C0521982 (UMLS CUI [1])
Response
Code List
Response after second transplant
CL Item
sCR (0)
CL Item
CR (1)
CL Item
vgPR (2)
CL Item
PR (3)
CL Item
SD (5)
CL Item
PD (6)
Date of evaluation
Item
Date of evaluation
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Initial diagnosis: Multiple myeloma
Item
Subtype
integer
C0449560 (UMLS CUI [1])
Subtype
Code List
Subtype
CL Item
IgG (1)
CL Item
IgA (2)
CL Item
IgM (3)
CL Item
IgD (4)
CL Item
Light chain (5)
Item
Light chain
integer
C0332307 (UMLS CUI [1,1])
C0021038 (UMLS CUI [1,2])
Light chain
Code List
Light chain
CL Item
Kappa (k)
CL Item
Lambda (l)
Item
Salmon-Durie Stage
integer
C3846373 (UMLS CUI [1])
Salmon-Durie Stage
Code List
Salmon-Durie Stage
CL Item
I (1)
CL Item
II (2)
CL Item
III (3)
Item
Salmon-Durie Stage codicil
integer
C3846373 (UMLS CUI [1])
Salmon-Durie Stage
Code List
Salmon-Durie Stage codicil
CL Item
A (a)
CL Item
B (b)
Item
ISS Stage
integer
C2346508 (UMLS CUI [1])
ISS Stage
Code List
ISS Stage
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
beta2-Microglobulin
Item
beta2-Microglobulin
integer
C0005149 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Cytogenetics
Item
Cytogenetic examination done?
boolean
C0010802 (UMLS CUI [1])
Cytogenetics
Item
Cytogenetics:please specify
text
C0010802 (UMLS CUI [1])
Cytogenetic examination date
Item
Cytogenetic examination date
date
C0011008 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
Contrast infiltration
Item
Contrast infiltration
integer
C0009924 (UMLS CUI [1,1])
C0332448 (UMLS CUI [1,2])
Contrast examination date
Item
Contrast examination date
date
C0011008 (UMLS CUI [1,1])
C0542435 (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])
Osteolysis
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)
Complications
Item
Complications:please specify
text
C0009566 (UMLS CUI [1])
Item Group
Vital signs
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Blood pressure
Item
Systolic blood pressure
integer
C0005823 (UMLS CUI [1])
Blood pressure
Item
Diastolic blood pressure
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
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)
ECG findings
Item
ECG normal?
boolean
C0438154 (UMLS CUI [1])
ECG findings
Item
Please specify any pathologic ECG findings
text
C0438154 (UMLS CUI [1])
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