ID

18245

Beschreibung

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00622336

Link

https://clinicaltrials.gov/show/NCT00622336

Stichworte

Versionen (1)
  1. 26.10.16 26.10.16 -
Hochgeladen am

26. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00622336

Englisch

Eligibility Multiple Myeloma NCT00622336

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
understand and voluntarily sign an informed consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years at time of signing the informed consent form.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
able to adhere to the study visit schedule and other protocol requirements
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
participants with multiple myeloma and were enrolled in either thal-mm-003, cc-5013-mm-009, or cc-5013-mm-010 and discontinued study therapy with thalidomide and high-dose dexamethasone or high-dose dexamethasone alone due to:
Beschreibung

Multiple Myeloma | Thalidomide Discontinued | Dexamethasone High dose Discontinued

Datentyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0039736
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0011777
UMLS CUI [3,2]
C0444956
UMLS CUI [3,3]
C1444662
documented disease progression or inability to tolerate the lowest dosing regimen allowed on previous protocol without a grade 3 or 4 toxicity.
Beschreibung

Dexamethasone High dose Due to Disease Progression | Toxicity | CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011777
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0242656
UMLS CUI [2]
C0600688
UMLS CUI [3]
C1516728
eastern cooperative oncology group (ecog) performance status score 0,1,2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
recovery from thalidomide or dexamethasone-related toxicity to ≤ grade 2 (nci ctc)
Beschreibung

Toxic effect | CTCAE Grades | Thalidomide Related Toxic effect | Dexamethasone Related Toxic effect | Patient Recovered

Datentyp

boolean

Alias
UMLS CUI [1]
C0600688
UMLS CUI [2]
C1516728
UMLS CUI [3,1]
C0039736
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0600688
UMLS CUI [4,1]
C0011777
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0600688
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C0521108
females of child-bearing potential (fcbp) must agree to using two methods of contraception
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior development of a ≥ grade 2 allergic reaction/hypersensitivity or prior development of a grade ≥ 3 rash or desquamation while taking thalidomide national cancer institute common toxicity criteria (nci ctc)
Beschreibung

Allergic Reaction Thalidomide | Hypersensitivity Thalidomide | CTCAE Grades | Exanthema | Peeling of skin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0039736
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039736
UMLS CUI [3]
C1516728
UMLS CUI [4]
C0015230
UMLS CUI [5]
C0237849
use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
Beschreibung

Therapeutic procedure Against Multiple Myeloma | Investigational Therapy Against Multiple Myeloma | Therapies, Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0026764
UMLS CUI [3]
C0949266
any serious medical condition, laboratory abnormality, or psychiatric illness that will prevent the participant from signing the informed consent form or that will place the participant at an unacceptable risk for toxicity if he/she participates in the study.
Beschreibung

Medical condition Preventing Informed Consent | LABORATORY ABNORMALITIES Preventing Informed Consent | Mental disorder Preventing Informed Consent | Medical condition Resulting in Risk Toxic effect | LABORATORY ABNORMALITIES Resulting in Risk Toxic effect | Mental disorder Resulting in Risk Toxic effect | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0332294
UMLS CUI [4,3]
C0035647
UMLS CUI [4,4]
C0600688
UMLS CUI [5,1]
C1853129
UMLS CUI [5,2]
C0332294
UMLS CUI [5,3]
C0035647
UMLS CUI [5,4]
C0600688
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0332294
UMLS CUI [6,3]
C0035647
UMLS CUI [6,4]
C0600688
UMLS CUI [7]
C2348568
pregnant or lactating females.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior therapy with cc-5013; prior history of malignancies, other than multiple myeloma (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast), unless subject has been free of disease for ≥ 5 years
Beschreibung

CC 5013 | Malignant Neoplasms | Multiple Myeloma | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Breast Carcinoma In situ

Datentyp

boolean

Alias
UMLS CUI [1]
C1134588
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0026764
UMLS CUI [4]
C0007117
UMLS CUI [5]
C0553723
UMLS CUI [6]
C0851140
UMLS CUI [7,1]
C0678222
UMLS CUI [7,2]
C0444498
more than 4 months has elapsed since the last dose of study drug was administered on study tal mm-003, cc-5013-mm-009, cc-5013-mm-010
Beschreibung

Elapsed Time Since Investigational New Drug Dose Last

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C1517741
absolute neutrophil count (anc) <1,000cells/mm^3 (1.0 x 10^9/l)
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count <75,000/mm^3 (30 x 10^9/l) for those with <50% if the bone marrow nucleated cells re plasma cells; platelet count <30,000/mm^3 (30 x 10^9/l) for those with <50% if the bone marrow nucleated cells re plasma cells
Beschreibung

Platelet Count measurement | Nucleated cells Bone marrow | Plasma Cells

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C2738468
UMLS CUI [3]
C0032112
serum creatinine >2.5mg/dl; serum sgot/ast or sgpt/alt x upper limits of normal (uln)
Beschreibung

Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
serum total bilirubin >2.0mg/d/l
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
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Ähnliche Modelle

Eligibility Multiple Myeloma NCT00622336

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
understand and voluntarily sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years at time of signing the informed consent form.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
able to adhere to the study visit schedule and other protocol requirements
boolean
C0525058 (UMLS CUI [1])
Multiple Myeloma | Thalidomide Discontinued | Dexamethasone High dose Discontinued
Item
participants with multiple myeloma and were enrolled in either thal-mm-003, cc-5013-mm-009, or cc-5013-mm-010 and discontinued study therapy with thalidomide and high-dose dexamethasone or high-dose dexamethasone alone due to:
boolean
C0026764 (UMLS CUI [1])
C0039736 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0011777 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
Dexamethasone High dose Due to Disease Progression | Toxicity | CTCAE Grades
Item
documented disease progression or inability to tolerate the lowest dosing regimen allowed on previous protocol without a grade 3 or 4 toxicity.
boolean
C0011777 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0242656 (UMLS CUI [1,4])
C0600688 (UMLS CUI [2])
C1516728 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score 0,1,2
boolean
C1520224 (UMLS CUI [1])
Toxic effect | CTCAE Grades | Thalidomide Related Toxic effect | Dexamethasone Related Toxic effect | Patient Recovered
Item
recovery from thalidomide or dexamethasone-related toxicity to ≤ grade 2 (nci ctc)
boolean
C0600688 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
C0039736 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0600688 (UMLS CUI [3,3])
C0011777 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0600688 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C0521108 (UMLS CUI [5,2])
Childbearing Potential Contraceptive methods
Item
females of child-bearing potential (fcbp) must agree to using two methods of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Allergic Reaction Thalidomide | Hypersensitivity Thalidomide | CTCAE Grades | Exanthema | Peeling of skin
Item
prior development of a ≥ grade 2 allergic reaction/hypersensitivity or prior development of a grade ≥ 3 rash or desquamation while taking thalidomide national cancer institute common toxicity criteria (nci ctc)
boolean
C1527304 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039736 (UMLS CUI [2,2])
C1516728 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C0237849 (UMLS CUI [5])
Therapeutic procedure Against Multiple Myeloma | Investigational Therapy Against Multiple Myeloma | Therapies, Investigational
Item
use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C0949266 (UMLS CUI [3])
Medical condition Preventing Informed Consent | LABORATORY ABNORMALITIES Preventing Informed Consent | Mental disorder Preventing Informed Consent | Medical condition Resulting in Risk Toxic effect | LABORATORY ABNORMALITIES Resulting in Risk Toxic effect | Mental disorder Resulting in Risk Toxic effect | Study Subject Participation Status
Item
any serious medical condition, laboratory abnormality, or psychiatric illness that will prevent the participant from signing the informed consent form or that will place the participant at an unacceptable risk for toxicity if he/she participates in the study.
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C1853129 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0332294 (UMLS CUI [4,2])
C0035647 (UMLS CUI [4,3])
C0600688 (UMLS CUI [4,4])
C1853129 (UMLS CUI [5,1])
C0332294 (UMLS CUI [5,2])
C0035647 (UMLS CUI [5,3])
C0600688 (UMLS CUI [5,4])
C0004936 (UMLS CUI [6,1])
C0332294 (UMLS CUI [6,2])
C0035647 (UMLS CUI [6,3])
C0600688 (UMLS CUI [6,4])
C2348568 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
CC 5013 | Malignant Neoplasms | Multiple Myeloma | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Breast Carcinoma In situ
Item
prior therapy with cc-5013; prior history of malignancies, other than multiple myeloma (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast), unless subject has been free of disease for ≥ 5 years
boolean
C1134588 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0026764 (UMLS CUI [3])
C0007117 (UMLS CUI [4])
C0553723 (UMLS CUI [5])
C0851140 (UMLS CUI [6])
C0678222 (UMLS CUI [7,1])
C0444498 (UMLS CUI [7,2])
Elapsed Time Since Investigational New Drug Dose Last
Item
more than 4 months has elapsed since the last dose of study drug was administered on study tal mm-003, cc-5013-mm-009, cc-5013-mm-010
boolean
C2826303 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
Absolute neutrophil count
Item
absolute neutrophil count (anc) <1,000cells/mm^3 (1.0 x 10^9/l)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement | Nucleated cells Bone marrow | Plasma Cells
Item
platelet count <75,000/mm^3 (30 x 10^9/l) for those with <50% if the bone marrow nucleated cells re plasma cells; platelet count <30,000/mm^3 (30 x 10^9/l) for those with <50% if the bone marrow nucleated cells re plasma cells
boolean
C0032181 (UMLS CUI [1])
C2738468 (UMLS CUI [2])
C0032112 (UMLS CUI [3])
Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum creatinine >2.5mg/dl; serum sgot/ast or sgpt/alt x upper limits of normal (uln)
boolean
C0201976 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Serum total bilirubin measurement
Item
serum total bilirubin >2.0mg/d/l
boolean
C1278039 (UMLS CUI [1])
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