ID

4433

Description

ODM derived from http://clinicaltrials.gov/show/NCT00777998

Link

http://clinicaltrials.gov/show/NCT00777998

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00777998 Multiple Myeloma

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 55 Years
Description

age 18 Years to 55 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Multiple Myeloma Stage II or III acc. to Salmon and Durie
Description

Multiple Myeloma Stage II or III acc. to Salmon and Durie

Data type

boolean

Alias
UMLS CUI 2011AA
C0278723
UMLS CUI 2011AA
C0278724
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patient's written informed consent
Description

Patient's written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment
Description

Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C2698977
UMLS CUI 2011AA
C0035150
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)
Description

a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)

Data type

boolean

Alias
UMLS CUI 2011AA
C1302181
SNOMED CT 2011_0131
399042005
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0677874
SNOMED CT 2011_0131
103338009
UMLS CUI 2011AA
C1521726
SNOMED CT 2011_0131
103337004
UMLS CUI 2011AA
C0547040
SNOMED CT 2011_0131
255605001
UMLS CUI 2011AA
C0544452
SNOMED CT 2011_0131
277022003
UMLS CUI 2011AA
C1335499
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
More than eight chemotherapy cycles prior to registration
Description

More than eight chemotherapy cycles prior to registration

Data type

boolean

Alias
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C1302181
SNOMED CT 2011_0131
399042005
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Description

severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
total bilirubin, SGPT or SGOT > 3 times upper the normal level
Description

total bilirubin, SGPT or SGOT > 3 times upper the normal level

Data type

boolean

Alias
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
LVEF - Left ventricular ejection fraction
Description

Left ventricular ejection fraction < 30 %

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
Creatinine clearance (CrCl) measurement
Description

Creatinine Clearance < 30 ml/min

Data type

boolean

Alias
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
DLCO < 35 % and/or receiving supplementary continuous oxygen
Description

DLCO < 35 % and/or receiving supplementary continuous oxygen

Data type

boolean

Alias
UMLS CUI 2011AA
C1516251
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0919655
MedDRA 14.1
10050322
HIV Seropositivity
Description

Positive serology for HIV

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Pregnant or lactating women
Description

Pregnant or lactating women

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Participation in another trial at the time of registration
Description

Participation in another trial at the time of registration

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1516879
Preceding autologous stem cell transplantation
Description

Preceding autologous stem cell transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1831743
age > 56 years
Description

age > 56 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 55 Years
Item
age 18 Years to 55 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Multiple Myeloma Stage II or III acc. to Salmon and Durie
Item
Multiple Myeloma Stage II or III acc. to Salmon and Durie
boolean
C0278723 (UMLS CUI 2011AA)
C0278724 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patient's written informed consent
Item
Patient's written informed consent
boolean
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment
Item
Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C2698977 (UMLS CUI 2011AA)
C0035150 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0677582 (UMLS CUI 2011AA)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)
Item
a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)
boolean
C1302181 (UMLS CUI 2011AA)
399042005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0677874 (UMLS CUI 2011AA)
103338009 (SNOMED CT 2011_0131)
C1521726 (UMLS CUI 2011AA)
103337004 (SNOMED CT 2011_0131)
C0547040 (UMLS CUI 2011AA)
255605001 (SNOMED CT 2011_0131)
C0544452 (UMLS CUI 2011AA)
277022003 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
More than eight chemotherapy cycles prior to registration
Item
More than eight chemotherapy cycles prior to registration
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C1302181 (UMLS CUI 2011AA)
399042005 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
Item
severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
total bilirubin, SGPT or SGOT > 3 times upper the normal level
Item
total bilirubin, SGPT or SGOT > 3 times upper the normal level
boolean
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
Left ventricular ejection fraction < 30 %
Item
LVEF - Left ventricular ejection fraction
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
Creatinine Clearance < 30 ml/min
Item
Creatinine clearance (CrCl) measurement
boolean
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
DLCO < 35 % and/or receiving supplementary continuous oxygen
Item
DLCO < 35 % and/or receiving supplementary continuous oxygen
boolean
C1516251 (UMLS CUI 2011AA)
C0750536 (UMLS CUI 2011AA)
C0919655 (UMLS CUI 2011AA)
10050322 (MedDRA 14.1)
Positive serology for HIV
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Pregnant or lactating women
Item
Pregnant or lactating women
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Participation in another trial at the time of registration
Item
Participation in another trial at the time of registration
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Preceding autologous stem cell transplantation
Item
Preceding autologous stem cell transplantation
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1831743 (UMLS CUI 2011AA)
age > 56 years
Item
age > 56 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
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