ID

43901

Beskrivning

Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00086216

Länk

https://clinicaltrials.gov/show/NCT00086216

Nyckelord

Versioner (2)
  1. 2016-10-23 2016-10-23 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT00086216

Engelsk

Eligibility Multiple Myeloma NCT00086216

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented history of multiple myeloma,
Beskrivning

Multiple Myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
failed at least two prior regimens for multiple myeloma,
Beskrivning

Multiple Myeloma | Regimen Quantity failed

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C0040808
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
18 years of age or older,
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog(zubrod)ps of 0 to 2,
Beskrivning

Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C3714786
screening evaluation for determining eligibility prior to enrollment,
Beskrivning

Screening Evaluation Eligibility Determination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1409616
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0013893
signed informed consent form,
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
Beskrivning

Pharmacotherapy Against Multiple Myeloma | Adrenal Cortex Hormones Against Multiple Myeloma | Chemotherapy Against Multiple Myeloma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0026764
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0026764
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0026764
renal insufficiency (serum creatinine levels of > 2mg/dl),
Beskrivning

Renal Insufficiency | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
mucosal bleeding,
Beskrivning

Mucosal bleeding

Datatyp

boolean

Alias
UMLS CUI [1]
C2748540
any condition which in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
Beskrivning

Condition At risk Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
clinically relevant active infection or co-morbid medical conditions.
Beskrivning

Communicable Disease Relevant Clinical | Comorbidity Relevant Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0205210
prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
Beskrivning

Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
patients with non-secretory myeloma.
Beskrivning

Non-secretory myeloma

Datatyp

boolean

Alias
UMLS CUI [1]
C0456845
as atiprimod is a potent inhibitor or cyp2d6, patients taking drugs that are substrates of cyp2d6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.
Beskrivning

antiprimod | CYP2D6 | Adrenergic beta-Antagonists | Antidepressive Agents | Antipsychotic Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C1579206
UMLS CUI [2]
C0057223
UMLS CUI [3]
C0001645
UMLS CUI [4]
C0003289
UMLS CUI [5]
C0040615
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Similar models

Eligibility Multiple Myeloma NCT00086216

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Myeloma
Item
documented history of multiple myeloma,
boolean
C0026764 (UMLS CUI [1])
Multiple Myeloma | Regimen Quantity failed
Item
failed at least two prior regimens for multiple myeloma,
boolean
C0026764 (UMLS CUI [1])
C0040808 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Age
Item
18 years of age or older,
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
ecog(zubrod)ps of 0 to 2,
boolean
C3714786 (UMLS CUI [1])
Screening Evaluation Eligibility Determination
Item
screening evaluation for determining eligibility prior to enrollment,
boolean
C1409616 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,3])
Informed Consent
Item
signed informed consent form,
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmacotherapy Against Multiple Myeloma | Adrenal Cortex Hormones Against Multiple Myeloma | Chemotherapy Against Multiple Myeloma
Item
concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
boolean
C0013216 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0026764 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0026764 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0026764 (UMLS CUI [3,3])
Renal Insufficiency | Creatinine measurement, serum
Item
renal insufficiency (serum creatinine levels of > 2mg/dl),
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Mucosal bleeding
Item
mucosal bleeding,
boolean
C2748540 (UMLS CUI [1])
Condition At risk Study Subject Participation Status
Item
any condition which in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Communicable Disease Relevant Clinical | Comorbidity Relevant Clinical
Item
clinically relevant active infection or co-morbid medical conditions.
boolean
C0009450 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated
Item
prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Non-secretory myeloma
Item
patients with non-secretory myeloma.
boolean
C0456845 (UMLS CUI [1])
antiprimod | CYP2D6 | Adrenergic beta-Antagonists | Antidepressive Agents | Antipsychotic Agents
Item
as atiprimod is a potent inhibitor or cyp2d6, patients taking drugs that are substrates of cyp2d6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.
boolean
C1579206 (UMLS CUI [1])
C0057223 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
C0040615 (UMLS CUI [5])
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