ID

30881

Beschreibung

A Study Evaluating the Activity, Safety and Pharmacology of Two Doses of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00999830

Link

https://clinicaltrials.gov/show/NCT00999830

Stichworte

Versionen (1)
  1. 30.06.18 30.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. Juni 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00999830

Englisch

Eligibility Multiple Myeloma NCT00999830

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. mm which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
Beschreibung

First line treatment Multiple Myeloma | Requirement Initially Systemic therapy | Chemotherapy Dose conventional | Chemotherapy High dose | Transplantation of autologous hematopoietic stem cell | Consolidation therapy | Consolidation therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0026764
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C1515119
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0439858
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0444956
UMLS CUI [5]
C1831743
UMLS CUI [6]
C1511484
UMLS CUI [7,1]
C1511484
UMLS CUI [7,2]
C0332197
2. residual disease considered as evaluable with:
Beschreibung

Residual disease Evaluable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543478
UMLS CUI [1,2]
C1516986
quantifiable serum m-protein: ≥ 3 g/l, except for spike in the beta globulin area. in this particular case serum m-protein is considered quantifiable if ≥
Beschreibung

Serum M Protein Measurement | Exception m-spike Beta Globulin Area

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0242485
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0241988
UMLS CUI [2,3]
C0005157
UMLS CUI [2,4]
C0205146
10g/l
Beschreibung

ID.4

Datentyp

boolean

if serum m-protein is < 3g/l, measurable involved free light chains ≥ 100 mg/l and an abnormal free light chains ratio (<0.26 or > 1.65)
Beschreibung

Serum M Protein Measurement | Free Immunoglobulin Light Chain Involved Measurement | Serum Immunoglobulin Free Light Chain Ratio Abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0242485
UMLS CUI [2,1]
C0806492
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0242485
UMLS CUI [3]
C2826181
3. responses which are partial (pr and vgpr) and in plateau
Beschreibung

Disease Response | Partial response | Very Good Partial Response | Response Plateau

Datentyp

boolean

Alias
UMLS CUI [1]
C1704632
UMLS CUI [2]
C1521726
UMLS CUI [3]
C4053871
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C2964353
partial response should meet the imwg uniform response criteria: a ≥ 50% reduction from value of serum m-protein before the first line chemotherapy treatment and a reduction in 24h urinary m-protein by ≥ 90% or to < 200 mg /24h;
Beschreibung

Partial response Criteria | Serum M Protein Percentage Reduction | Status pre- First line Chemotherapy | M Protein Percentage Reduction 24 Hour Urine Test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521726
UMLS CUI [1,2]
C0243161
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0392756
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C1708063
UMLS CUI [3,3]
C0392920
UMLS CUI [4,1]
C0700271
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0392756
UMLS CUI [4,4]
C1255149
very good partial response according to the imwg uniform response criteria with 90% or greater reduction in serum m-protein plus urine m-protein level < 100 mg/24h; furthermore the m-protein should spike in the gamma globulin area;
Beschreibung

Very Good Partial Response Criteria | Serum M Protein Percentage Reduction | M Protein Level 24 Hour Urine Test | m-spike Gamma globulin Area

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4053871
UMLS CUI [1,2]
C0243161
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0392756
UMLS CUI [3,1]
C0700271
UMLS CUI [3,2]
C0441889
UMLS CUI [3,3]
C1255149
UMLS CUI [4,1]
C0241988
UMLS CUI [4,2]
C0017007
UMLS CUI [4,3]
C0205146
plateau phase is defined by :
Beschreibung

Plateau Phase Definition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2964353
UMLS CUI [1,2]
C0205390
UMLS CUI [1,3]
C1704788
for patients with serum m-protein ≥ 3g/l: stable levels of m-protein in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. fluctuations of ± 25 % and ± 2 g/l in serum m-protein levels are allowed.
Beschreibung

Serum M Protein Measurement | Serum M Protein Level Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0242485
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0700271
UMLS CUI [2,3]
C0441889
UMLS CUI [2,4]
C0205360
for patients with serum m-protein < 3g/l: stable levels free light chains in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. fluctuations of ± 25 % of involved serum free light chain are allowed.
Beschreibung

Serum M Protein Measurement | Serum Free Immunoglobulin Light Chain Level Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0229671
UMLS CUI [1,2]
C0700271
UMLS CUI [1,3]
C0242485
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0806492
UMLS CUI [2,3]
C0441889
UMLS CUI [2,4]
C0205360
4. ecog performance status of 0, 1 or 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. clinical laboratory values at screening:
Beschreibung

Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
calculated creatinine clearance (according to mdrd) > 50 ml/min
Beschreibung

Creatinine clearance MDRD

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0812399
UMLS CUI [1,2]
C3839656
platelet > 50 x 109 /l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
anc > 1 x 109 /l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
bilirubin levels < 1.5 uln; alt and ast < 2.5 uln
Beschreibung

Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
6. male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, iucd, barrier method of contraception in conjunction with spermicidal jelly) throughout the study.
Beschreibung

Gender Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraception, Barrier | Spermicidal Jelly

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0004764
UMLS CUI [5]
C2985330
7. signed inform consent obtained before any trial-related activities
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age < 18 years old or > 75 years old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. previous consolidation/ maintenance therapy by imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
Beschreibung

Consolidation therapy | Maintenance therapy | Immunomodulators | Thalidomide | Lenalidomide | Bortezomib

Datentyp

boolean

Alias
UMLS CUI [1]
C1511484
UMLS CUI [2]
C0677908
UMLS CUI [3]
C1527392
UMLS CUI [4]
C0039736
UMLS CUI [5]
C1144149
UMLS CUI [6]
C1176309
3. treatment with chemotherapy, systemic corticosteroid within the previous 2 months
Beschreibung

Chemotherapy | CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C3653708
4. treatment with growth factors (epo, g- or gm-csf) within the previous 1 month
Beschreibung

Growth Factor | Epo | G-CSF | GM-CSF

Datentyp

boolean

Alias
UMLS CUI [1]
C0018284
UMLS CUI [2]
C0014822
UMLS CUI [3]
C0079459
UMLS CUI [4]
C0079460
5. radiotherapy for bone or visceral lesion within the last 3 months
Beschreibung

Therapeutic radiology procedure Bone lesion | Therapeutic radiology procedure Lesion Visceral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0238792
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0442045
6. use of any investigational agent within the last 2 months
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
7. primary or associated amyloidosis
Beschreibung

Primary amyloidosis | Amyloidosis Associated

Datentyp

boolean

Alias
UMLS CUI [1]
C0268381
UMLS CUI [2,1]
C0002726
UMLS CUI [2,2]
C0332281
8. peripheral neuropathy of grade ≥ iii according to the ctcae of the nci
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
9. abnormal cardiac status with any of the following
Beschreibung

Cardiac Status Abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C0205161
1. nyha stage iii or iv congestive heart failure
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
2. myocardial infarction within the previous 6 months
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
3. symptomatic cardiac arrhythmia despite treatment
Beschreibung

Cardiac Arrhythmia Symptomatic | Therapeutic procedure Resistant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332325
10. current active infectious disease or positive serology for hiv, hcv or positive hbs antigen
Beschreibung

Communicable Disease | HIV Seropositivity | Serology positive Hepatitis C virus | Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019699
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0220847
UMLS CUI [4]
C0149709
11. history of or current auto-immune disease
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
12. serious concurrent uncontrolled medical disorder
Beschreibung

Comorbidity Serious Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
13. history of other malignancy for less then 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
Beschreibung

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
14. history of allogenic hematopoietic cell or solid organ transplantation
Beschreibung

Allogeneic Hematopoietic Stem Cell Transplantation | Solid organ transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C1705576
UMLS CUI [2]
C0730400
15. pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
16. any medical condition which is regarded by the investigator as incompatible with the study participation
Beschreibung

Medical condition Inconsistent Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C2348568
17. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Beschreibung

Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0241888
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C3850138
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0017444
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00999830

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
First line treatment Multiple Myeloma | Requirement Initially Systemic therapy | Chemotherapy Dose conventional | Chemotherapy High dose | Transplantation of autologous hematopoietic stem cell | Consolidation therapy | Consolidation therapy Absent
Item
1. mm which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
boolean
C1708063 (UMLS CUI [1,1])
C0026764 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C1515119 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0439858 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C1831743 (UMLS CUI [5])
C1511484 (UMLS CUI [6])
C1511484 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Residual disease Evaluable
Item
2. residual disease considered as evaluable with:
boolean
C0543478 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
Serum M Protein Measurement | Exception m-spike Beta Globulin Area
Item
quantifiable serum m-protein: ≥ 3 g/l, except for spike in the beta globulin area. in this particular case serum m-protein is considered quantifiable if ≥
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0241988 (UMLS CUI [2,2])
C0005157 (UMLS CUI [2,3])
C0205146 (UMLS CUI [2,4])
ID.4
Item
10g/l
boolean
Serum M Protein Measurement | Free Immunoglobulin Light Chain Involved Measurement | Serum Immunoglobulin Free Light Chain Ratio Abnormal
Item
if serum m-protein is < 3g/l, measurable involved free light chains ≥ 100 mg/l and an abnormal free light chains ratio (<0.26 or > 1.65)
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0806492 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
C2826181 (UMLS CUI [3])
Disease Response | Partial response | Very Good Partial Response | Response Plateau
Item
3. responses which are partial (pr and vgpr) and in plateau
boolean
C1704632 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C4053871 (UMLS CUI [3])
C1704632 (UMLS CUI [4,1])
C2964353 (UMLS CUI [4,2])
Partial response Criteria | Serum M Protein Percentage Reduction | Status pre- First line Chemotherapy | M Protein Percentage Reduction 24 Hour Urine Test
Item
partial response should meet the imwg uniform response criteria: a ≥ 50% reduction from value of serum m-protein before the first line chemotherapy treatment and a reduction in 24h urinary m-protein by ≥ 90% or to < 200 mg /24h;
boolean
C1521726 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0392756 (UMLS CUI [2,4])
C0332152 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0700271 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0392756 (UMLS CUI [4,3])
C1255149 (UMLS CUI [4,4])
Very Good Partial Response Criteria | Serum M Protein Percentage Reduction | M Protein Level 24 Hour Urine Test | m-spike Gamma globulin Area
Item
very good partial response according to the imwg uniform response criteria with 90% or greater reduction in serum m-protein plus urine m-protein level < 100 mg/24h; furthermore the m-protein should spike in the gamma globulin area;
boolean
C4053871 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0392756 (UMLS CUI [2,4])
C0700271 (UMLS CUI [3,1])
C0441889 (UMLS CUI [3,2])
C1255149 (UMLS CUI [3,3])
C0241988 (UMLS CUI [4,1])
C0017007 (UMLS CUI [4,2])
C0205146 (UMLS CUI [4,3])
Plateau Phase Definition
Item
plateau phase is defined by :
boolean
C2964353 (UMLS CUI [1,1])
C0205390 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
Serum M Protein Measurement | Serum M Protein Level Stable
Item
for patients with serum m-protein ≥ 3g/l: stable levels of m-protein in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. fluctuations of ± 25 % and ± 2 g/l in serum m-protein levels are allowed.
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0229671 (UMLS CUI [2,1])
C0700271 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Serum M Protein Measurement | Serum Free Immunoglobulin Light Chain Level Stable
Item
for patients with serum m-protein < 3g/l: stable levels free light chains in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. fluctuations of ± 25 % of involved serum free light chain are allowed.
boolean
C0229671 (UMLS CUI [1,1])
C0700271 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C0229671 (UMLS CUI [2,1])
C0806492 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
ECOG performance status
Item
4. ecog performance status of 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Laboratory Results
Item
5. clinical laboratory values at screening:
boolean
C1254595 (UMLS CUI [1])
Creatinine clearance MDRD
Item
calculated creatinine clearance (according to mdrd) > 50 ml/min
boolean
C0812399 (UMLS CUI [1,1])
C3839656 (UMLS CUI [1,2])
Platelet Count measurement
Item
platelet > 50 x 109 /l
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
anc > 1 x 109 /l
boolean
C0948762 (UMLS CUI [1])
Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
bilirubin levels < 1.5 uln; alt and ast < 2.5 uln
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Gender Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Contraception, Barrier | Spermicidal Jelly
Item
6. male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, iucd, barrier method of contraception in conjunction with spermicidal jelly) throughout the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C2985330 (UMLS CUI [5])
Informed Consent
Item
7. signed inform consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age < 18 years old or > 75 years old
boolean
C0001779 (UMLS CUI [1])
Consolidation therapy | Maintenance therapy | Immunomodulators | Thalidomide | Lenalidomide | Bortezomib
Item
2. previous consolidation/ maintenance therapy by imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
boolean
C1511484 (UMLS CUI [1])
C0677908 (UMLS CUI [2])
C1527392 (UMLS CUI [3])
C0039736 (UMLS CUI [4])
C1144149 (UMLS CUI [5])
C1176309 (UMLS CUI [6])
Chemotherapy | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
3. treatment with chemotherapy, systemic corticosteroid within the previous 2 months
boolean
C0392920 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
Growth Factor | Epo | G-CSF | GM-CSF
Item
4. treatment with growth factors (epo, g- or gm-csf) within the previous 1 month
boolean
C0018284 (UMLS CUI [1])
C0014822 (UMLS CUI [2])
C0079459 (UMLS CUI [3])
C0079460 (UMLS CUI [4])
Therapeutic radiology procedure Bone lesion | Therapeutic radiology procedure Lesion Visceral
Item
5. radiotherapy for bone or visceral lesion within the last 3 months
boolean
C1522449 (UMLS CUI [1,1])
C0238792 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0442045 (UMLS CUI [2,3])
Investigational New Drugs
Item
6. use of any investigational agent within the last 2 months
boolean
C0013230 (UMLS CUI [1])
Primary amyloidosis | Amyloidosis Associated
Item
7. primary or associated amyloidosis
boolean
C0268381 (UMLS CUI [1])
C0002726 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
Peripheral Neuropathy CTCAE Grades
Item
8. peripheral neuropathy of grade ≥ iii according to the ctcae of the nci
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cardiac Status Abnormal
Item
9. abnormal cardiac status with any of the following
boolean
C1999091 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification
Item
1. nyha stage iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction
Item
2. myocardial infarction within the previous 6 months
boolean
C0027051 (UMLS CUI [1])
Cardiac Arrhythmia Symptomatic | Therapeutic procedure Resistant
Item
3. symptomatic cardiac arrhythmia despite treatment
boolean
C0003811 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
Communicable Disease | HIV Seropositivity | Serology positive Hepatitis C virus | Hepatitis B surface antigen positive
Item
10. current active infectious disease or positive serology for hiv, hcv or positive hbs antigen
boolean
C0009450 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C0242089 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C0149709 (UMLS CUI [4])
Autoimmune Disease
Item
11. history of or current auto-immune disease
boolean
C0004364 (UMLS CUI [1])
Comorbidity Serious Uncontrolled
Item
12. serious concurrent uncontrolled medical disorder
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
13. history of other malignancy for less then 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Allogeneic Hematopoietic Stem Cell Transplantation | Solid organ transplant
Item
14. history of allogenic hematopoietic cell or solid organ transplantation
boolean
C1705576 (UMLS CUI [1])
C0730400 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
15. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Inconsistent Study Subject Participation Status
Item
16. any medical condition which is regarded by the investigator as incompatible with the study participation
boolean
C3843040 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Mental condition Interferes with Protocol Compliance | Condition Familial Interferes with Protocol Compliance | Sociological Factors Interfere with Protocol Compliance | Geographic Factors Interfere with Protocol Compliance
Item
17. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C3840291 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0241888 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C3850138 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0017444 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
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