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ID
13908
Beschrijving
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
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Versies (1)
- 2016-03-16 2016-03-16 -
Geüploaded op
16 mars 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Baseline visit LenaMain-Study
Similar models
Baseline Visit
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
C0021430 (UMLS CUI [1,2])
Screening Date
Item
Screening Date
date
C0011008 (UMLS CUI [1,1])
C1710032 (UMLS CUI [1,2])
C1710032 (UMLS CUI [1,2])
Inclusion date
Item
Date of Inclusion
date
C0011008 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
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])
C0449438 (UMLS CUI [1,2])
CL Item
sCR (0)
CL Item
CR (1)
CL Item
vgPR (2)
CL Item
PR (3)
CL Item
SD (5)
CL Item
PD (6)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
Branch A (1)
CL Item
Branch B (2)
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0332448 (UMLS CUI [1,2])
Extramedullary lesion
Item
Extramedullary lesion
boolean
C1517060 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
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])
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])
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)
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])
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])
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])
CL Item
positive (1)
CL Item
negative (2)
Comment
Item
Comment on serum immunofixation
text
C0947611 (UMLS CUI [1])
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])
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])
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])
Childbearing potential
Item
Is the subject of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
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)
Quality of life score
Item
Total Score QoL
float
C3476431 (UMLS CUI [1])