ID

43901

Description

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

Link

https://clinicaltrials.gov/show/NCT00086216

Keywords

  1. 10/23/16 10/23/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Multiple Myeloma NCT00086216

Eligibility Multiple Myeloma NCT00086216

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented history of multiple myeloma,
Description

Multiple Myeloma

Data type

boolean

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

Multiple Myeloma | Regimen Quantity failed

Data type

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,
Description

Age

Data type

boolean

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

Zubrod Performance Status

Data type

boolean

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

Screening Evaluation Eligibility Determination

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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),
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

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

Mucosal bleeding

Data type

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.
Description

Condition At risk Study Subject Participation Status

Data type

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.
Description

Communicable Disease Relevant Clinical | Comorbidity Relevant Clinical

Data type

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.
Description

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

Data type

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.
Description

Non-secretory myeloma

Data type

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.
Description

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

Data type

boolean

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

Similar models

Eligibility Multiple Myeloma NCT00086216

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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